Background

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, lower back pain, and vertebral subluxation.

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.

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 plaques, 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 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

Device Name	Manufacturer	Clearance Date	510(K) No.
Infrared Sciences Breastscan IR System	Infrared Sciences	Feb 2004	K032350
Telethermographic Camera, Series A, E, S, and P	FLIR Systems	Mar 2004	K033967
Notouch Breastscan	UE Lifesciences	Feb 2012	K113259
WoundVision Scout	WoundVision	Dec 2013	K131596
AlfaSight 9000 Thermographic System	Alfa Thermodiagnostics	Apr 2015	K150457
FirstSense Breast Exam®	First Sense Medical	Jun 2016	K160573
Sentinel BreastScan II System	First Sense Medical	Jan 2017	K162767
InTouchThermal Camera	InTouch Technologies	Feb 2019	K181716

Related Policies

• Scintimammography and Gamma Imaging of the Breast and Axilla (Policy #058 in the Radiology Section)
• Adult Breast Imaging (Policy #177 in the Radiology Section)

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources.

Breast Cancer

Clinical Context and Test Purpose

The purpose of using thermography in patients who are suspected of having breast cancer is to inform a decision whether to proceed to appropriate treatment or not.

The question addressed in this portion of the policy is: Does thermography when used to screen or diagnose breast cancer improve the net health outcome compared with standard mammographic techniques? Specifically, does the use of thermography improve diagnostic accuracy compared with standard screening mammography methods and is this increase in accuracy likely to improve health outcomes by leading to earlier diagnosis and treatment?

The following PICOs were used to select literature to inform this policy.

Patients

The relevant populations of interest are asymptomatic individuals being screened for breast cancer or individuals undergoing testing to diagnose breast cancer.

Interventions

The intervention of interest is thermography. The test would be performed in an outpatient setting.

Comparators

The following test is currently being used to make decisions about breast cancer diagnosis: mammography.

Outcomes

The outcome of interest for diagnostic accuracy is test validity (i.e., sensitivity, specificity). The primary outcomes of interest for clinical utility are overall survival and breast cancer-specific survival rates.

The potential beneficial outcomes of primary interest in the case of a true-negative would be the avoidance of unnecessary surgery and its associated consequences (e.g., morbidity, mortality, resource utilization, patient anxiety). The potential harms from a false-positive could be inappropriate assessment and improper management of patients with breast malignancies, which could result in the following: inappropriate surgical decisions, high frequency of unnecessary further testing, and unnecessary patient anxiety. The potential harms from a false-negative could be a determination that the patient does not have malignancy, which would lead to a delay in surgery and tumor diagnosis.

The timing for routine screening can be guided by national guidelines on breast cancer screening. The timing for diagnosis would be after an initial screening test or clinical examination.

Technically Reliable

Assessment of technical reliability focuses on specific tests and operators and requires a review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this policy and alternative sources exist. This policy focuses on the clinical validity and clinical utility.

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Systematic Reviews

Several systematic reviews of the published literature on the diagnostic accuracy of thermography were identified. A systematic review by Vreugdenburg et al (2013) identified 8 studies on thermography for diagnosis of breast cancer that included a valid reference standard (e.g., biopsy with histopathologic confirmation).^1, A previous systematic review by Fitzgerald and Berentson-Shaw (2012) identified 6 studies, one using thermography for breast cancer screening and the others using thermography to diagnose breast cancer among symptomatic women or those with a positive mammogram.^2, A summary of the characteristics of clinical validity for these systematic reviews is provided in Table 2. A summary of the clinical validity results is provided in Table 3. Study findings were not pooled due to heterogeneity in data reporting and assessment methodology utilized.

Table 2. Systematic Reviews: Characteristics of Clinical Validity of Thermography in Breast Cancer Screening or Diagnosis

Study	Study Population	Designa	Reference Standard	Threshold for Positive Index Test	Timing of Reference and Index Tests	Blinding of Assessors	Commentb
Vreugdenburg et al (2013)1,	For screening studies: asymptomatic women with unknown disease status For diagnostic studies: women with suspicious symptoms, suspicious findings on clinical examination, or women with an abnormal mammogram	Diagnostic, cross-sectional studies: Retrospective case-control; sample selection consecutive Prospective cohort; sample selection NR NR cohort; sample selection NR	Biopsy with histopathologic confirmation	Various	Reference Test Prior to Index Test: 1/8 Reference Test During Course of Study: 7/8	Studies blind to reference: Blind: 4/8 Not blind: 2/8 Unclear: 2/8 Studies blind to comparator: Blind: 2/8 Not blind: 3/8 Unclear: 2/8 N/A: 1/8	All 8 studies utilized different measurement scales and cut-off scores. Poor reporting of index and reference test timing.
Fitzgerald et al (2012)2,	For screening studies: asymptomatic women aged 40-65 For diagnostic studies: symptomatic women	Screening studies: Prospective cohort; NR sample selection Diagnostic studies: NR case-control; sample selection NR NR cohort; sample selection NR	Screening studies: mammography Diagnostic studies: biopsy with histopathologic confirmation	Various	In screening studies, only patients with positive index test received reference test. In diagnostic studies, timing of index and reference tests poorly reported.	In all studies, blinding was poorly reported.	Studies utilized various measurement scales and cut-off scores. Thermograms were scored by software, manually, or through a combination of methods. Screening study utilized more than one thermography device. Poor reporting of index and reference test timing.

NR: not reported.

^a Note 2 aspects of design: prospective, retrospective or nonconcurrent prospective; sample selection random or consecutive.

^b Note other characteristics that could bias or limit relevance such as use of historical data, evolution of technology, or practice setting.

Study; Subgroup	Initial N (Range)	Final N (Range)	Excluded N	Prevalence of Condition	Clinical Validity (95% Confidence Interval)
					Sensitivity	Specificity	PPV	NPV
Vreugdenberg et al (2013)1, Diagnostic studies	NR	1,709 (29-769)	565 (13-524)*	NR	25-97% (NR)	12-85% (NR)	24-81% (NR)	36-95% (NR)
Fitzgerald et al (2012)2, Diagnostic studies	1,224 (63-769)	NR	NR	NR	25-97% (NR)	12-85% (NR)	24-83% (NR)	36-95% (NR)
Fitzgerald et al (2012)2, Screening studies, at initial screening	10,229	NR	NR	NR	61% (NR)	74% (NR)	0.01% (NR)	1.00% (NR)
Fitzgerald et al (2012)2, Screening studies, at 5-yr follow-up	10,229	NR	NR	NR	28% (NR)	74% (NR)	0.01% (NR)	0.99% (NR)

*Only 3/8 studies reported the number of excluded patients in indicated subgroup.

Diagnostic Studies

Several studies have been published since the systematic reviews. Morales-Cervantes et al (2018) compared the accuracy of automated or manual thermography screening in 206 women scheduled for mammography in Mexico.^3,A retrospective study conducted in the U.S. by Neal et al (2018) assessed outcomes in 38 women referred for further breast imaging following abnormal thermography testing.^4,Omranipour et al (2016) compared the accuracy of thermography and mammography in 132 patients in Iran who had breast lesions and were candidates for breast biopsy.^5,Rassiwala et al (2014) in India reported on 1008 women being screened for breast cancer.^6, Summaries of characteristics and results of clinical validity for these diagnostic studies are provided in Tables 4 and 5.

Table 4. Diagnostic Study Characteristics of Clinical Validity of Thermography in Breast Cancer Screening or Diagnosis

Study	Study Population	Designa	Reference Standard	Threshold for Positive Index Test	Timing of Reference and Index Tests	Blinding of Assessors	Commentb
Morales-Cervantes et al (2018)3,	For screening study: women scheduled for consultation with clinical evidence of tumor suspicious for breast cancer and breast cancer risk factors	Prospective cohort, NR sample allocation	Biopsy with histopathologic confirmation	Automated Thermography (Thermal Score)c + (Thermal Score ≥2.5) - (Thermal Score < 2.5) Manual Thermography NR Mammography (BI-RADS Rating): NR	Reference testing performed for women with mammography BI-RADS score indicating suspicion for cancer. Mammography performed after thermography.	Blinding of mammography assessor with respect to thermography not described. Double-blinding indicated for manual assessment of thermograms by oncologist. Blinding of biopsy assessor not described.	Blinding and allocation poorly described. No data reported for mammography despite inclusion as comparator. Reported results may be biased and inaccurate due to selective use of reference tests.
Neal et al (2018)4,	For diagnostic study: women referred for conventional breast imaging (mammogram and/or ultrasound) for evaluation of abnormal thermography findings	Retrospective cohort, NR sample allocation	Biopsy with histopathologic confirmation or at least one year of clinical and/or imaging follow-up	Abnormal Thermography: Any report of abnormal findings Mammography: (BI-RADS Rating): + (B4-5) - (B1-3) Ultrasound (Mammography declined by Patient) of Mammography: NR	Thermography testing performed prior to mammography and/or ultrasound. Reference testing performed after index tests. Histopathological reference testing offered for women with BI-RADS score 4-5.	Blinding of assessors not described.	Blinding and allocation not described. Limited data reporting. Reference testing not uniform for all patients. Small study size with retrospective design. Long-term health outcomes not described.
Omranipour et al (2016)5,	For diagnostic study: women with breast lesions based on clinical, mammographic, or ultrasonographic finding in need of breast biopsy	Prospective cohort, NR sample selection	Core needle or surgical biopsy with histopathologic confirmation	Mammography (BI-RADS Rating): + (B4-5) - (B1-3) Thermography (Rating): + (TH3-5) - (TH1-2)	Reference testing performed after imaging index tests.	Mammography assessors blinded to thermography test results. Blinding of thermography and histopathology assessors not described.	Blinding and allocation poorly described. Concordance of risk classification cannot be assessed due to limited data reporting.
Rassiwala et al (2014)6,	For screening study: women aged 20-60 years without a prior diagnosis of breast cancer	Prospective cohort, NR sample allocation	For women with normal thermograms: clinical examination only. For women with ΔT ≥ 2.5: clinical, radiologic, and histopathologic examination.	Positive (Potentially having breast cancer) (ΔT ≥ 3) Abnormal (ΔT > 2.5, <3) Normal (ΔT ≤ 2.5)	Reference test provided only to women with abnormal or elevated thermography index test results.	NR	Blinding and allocation not described. Reported results may be biased and inaccurate due to selective use of reference tests.

BI-RADS: breast imaging reporting and data system; NR: not reported; ΔT: temperature gradient.

^a Note 2 aspects of design: prospective, retrospective or nonconcurrent prospective; sample selection random or consecutive.

^b Note other characteristics that could bias or limit relevance such as use of historical data, evolution of technology, or practice setting.

^c Thermal score is defined as the sum of the surface temperature difference at the site of the lesion compared to that of the contralateral breast and the vascularity score, based on the following scale: 1) absence of vascular patterns; 2) symmetrical or moderate vascular patterns; 3) significant vascular asymmetry; 4) vascular asymmetry extended in at least one-third of breast area.

Study; Subgroup	Initial N	Final N	Excluded Samples	Prevalence of Condition	Clinical Validity (95% Confidence Interval)
					Sensitivity	Specificity	PPV	NPV
Morales-Cervantes et al (2018)3,
Automated Thermography*	NR	206	NR	198 benign; 8 malignant	100% (NR)	68.68% (NR)	11.42% (NR)	100% (NR)
Manual Thermography*	NR	206	NR		87.50% (NR)	56.06% (NR)	7.44%	99.10%
Mammography	NR	206	NR		NR	NR	NR	NR
Neal et al (2018)4,
Abnormal Thermography	45	38	7	36 benign; 2 malignant	NA	NA	NR (2/38)	NA
Mammography following Abnormal Thermography	45	38	7		NR	NR	33.3%	100%
Omranipour et al (2016)5,	Initial N	Final N	Excluded Samples		Sensitivity	Specificity	PPV	NPV
Thermography	NR	132	NR	45 benign; 87 malignant	81.6% (NR)	57.8% (NR)	78.9% (NR)	61.9% (NR)
Mammography	NR	132	NR		80.5% (NR)	73.3% (NR)	85.4% (NR)	66.0% (NR)
Rassiwala et al (2014)6,
Thermography**	NR	1,008	NR	41 malignant in 49 women with positive or abnormal thermograms	97.6% (NR)	99.17% (NR)	83.67% (NR)	99.89% (NR)

* Clinical validity results for this subgroup must be interpreted with caution as subjects with normal mammograms did not undergo histopathologic reference testing for diagnostic confirmation.

** Clinical validity results for this subgroup must be interpreted with caution as subjects with normal thermograms did not undergo radiologic and histopathologic reference testing for diagnostic confirmation, only clinical assessment.

Table 6. Relevance Limitations: Breast Cancer Screening or Diagnosis

Study	Populationa	Interventionb	Comparatorc	Outcomesd	Duration of Follow-Upe
Morales-Cervantes et al (2018)3,	1, 4. Intended use population unclear; study population not representative of intended use (screening study enriched with patients with clinical symptoms).	1-2. Classification thresholds for manual thermographic assessment not described; BI-RADS version used unclear with no description of classification thresholds.	1-2. BI-RADS classification thresholds for mammography not defined; normal mammograms not compared to credible reference standard.	1, 3, 5. Study does not directly assess a key health outcome; key clinical validity outcomes not reported; adverse events of the test not described.
Neal et al (2018)4,		1. Classification thresholds for patients receiving ultrasounds after declining mammography not described; classification thresholds for thermography not evaluated.	1. Not compared to consistent reference standard.	1. Study does not report on key long-term health outcomes; key clinical validity outcomes not reported.	1. Follow-up duration not sufficient for patients not evaluated by biopsy.
Omranipour et al (2016)5,				1, 5. Study does not directly assess a key health outcome; adverse events of the test not described.
Rassiwala et al (2014)6,	4. Study population not representative of intended use (age for screening).		1-2. Classification thresholds not defined; normal index tests not compared to credible reference standard.	1, 4-5. Study does not directly assess a key health outcome; reclassification of diagnostic or risk categories not reported; adverse events of the test not described.

The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.

BI-RADS: breast imaging reporting and data system.

^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.

^b Intervention key: 1. Classification thresholds not defined; 2. Version used unclear; 3. Not intervention of interest.

^c Comparator key: 1. Classification thresholds not defined; 2. Not compared to credible reference standard; 3. Not compared to other tests in use for same purpose.

^d Outcomes key: 1. Study does not directly assess a key health outcome; 2. Evidence chain or decision model not explicated; 3. Key clinical validity outcomes not reported (sensitivity, specificity and predictive values); 4. Reclassification of diagnostic or risk categories not reported; 5. Adverse events of the test not described (excluding minor discomforts and inconvenience of venipuncture or noninvasive tests).

^e Follow-Up key: 1. Follow-up duration not sufficient with respect to natural history of disease (true positives, true negatives, false positives, false negatives cannot be determined).

^a Selection key: 1. Selection not described; 2. Selection not random or consecutive (i.e., convenience).

^bBlinding key: 1. Not blinded to results of reference or other comparator tests.

^cTest Delivery key: 1. Timing of delivery of index or reference test not described; 2. Timing of index and comparator tests not same; 3. Procedure for interpreting tests not described; 4. Expertise of evaluators not described.

^d Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.

^e Data Completeness key: 1. Inadequate description of indeterminate and missing samples; 2. High number of samples excluded; 3. High number loss to follow-up or missing data.

^f Statistical key: 1. Confidence intervals and/or p values not reported; 2. Comparison with other tests not reported.

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from randomized controlled trials.

No studies have demonstrated how the results of thermography could be used to enhance the management of breast cancer patients in a manner that would improve their health outcomes.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

It is not possible to construct a chain of evidence for clinical utility due to the lack of sufficient evidence that the diagnostic accuracy of thermography is at least as high as mammographic techniques for breast cancer screening and diagnosis.

Section Summary: Breast Cancer

Systematic reviews of studies evaluating the accuracy of thermography for diagnosing breast cancer found wide ranges of sensitivities and specificities and, where data are available, relatively low diagnostic accuracy compared with mammography. 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 patients with breast cancer.

Musculoskeletal Injuries

Clinical Context and Test Purpose

The purpose of using thermography in patients who have a musculoskeletal injury is to inform a decision whether to proceed to appropriate treatment or not.

The question addressed in this portion of the policy is: Does thermography when used to diagnose musculoskeletal injuries, improve the net health outcome compared with standard approaches. Specifically, does the use of thermography improve diagnostic accuracy compared with standard approaches (e.g., clinical examination, imaging with radiography or magnetic resonance imaging), and is this degree of increased accuracy likely to improve health outcomes by leading to earlier diagnosis and treatment?

The following PICOs were used to select literature to inform this policy.

Patients

The relevant population of interest are individuals with musculoskeletal pain.

Interventions

The intervention of interest is thermography. The test would be performed in an outpatient setting.

Comparators

The following tests and practices are currently being used to make decisions about musculoskeletal injuries: standard care without imaging and other forms of imaging (e.g., with radiography, magnetic resonance imaging).

Outcomes

The outcomes of interest for diagnostic accuracy include test accuracy and test validity (i.e., sensitivity, specificity). The primary outcomes of interest for clinical utility are a reduction in pain symptoms and improvement in functional ability. The timing would be following a musculoskeletal injury.

Technically Reliable

Assessment of technical reliability focuses on specific tests and operators and requires a review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this policy and alternative sources exist. This policy focuses on the clinical validity and clinical utility.

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Systematic Reviews

A systematic review by Sanchis-Sanchez et al (2014) evaluated the literature on thermography for diagnosing musculoskeletal injuries.^7,Six studies met the eligibility criteria (n=416); 3 included patients with suspected stress fractures (n=119) and the remainder addressed other musculoskeletal injuries. Characteristics and results of clinical validity for stress fracture diagnostic studies were reported and summaries are provided in Tables 8 and 9. A systematic review by Vardasca et al (2019) evaluated the literature on musculoskeletal applications of thermography specific to the arm and forearm. However, the review mainly focused on correlations between skin surface temperatures and physical condition or health recovery monitoring. As diagnostic accuracy data was not extracted or pooled from included studies, this review was not assessed for evidence of clinical validity.

Table 8. Systematic Review: Characteristics of Clinical Validity of Thermography in Musculoskeletal Injury

Study	Study Population	Designa	Reference Standard	Threshold for Positive Index Test	Timing of Reference and Index Tests	Blinding of Assessors	Commentb
Sanchis-Sanchez (2014)7,	For diagnostic studies: studies reporting on the diagnostic accuracy of infrared thermal imaging in the diagnosis of musculoskeletal injuries (e.g., bone fractures, dislocations, sprains, muscle contractures, tendinopathy, contusions, or compartment syndrome) that utilized a recognized reference standard (e.g., radiographs, CT, MRI, or ultrasound scanning)	Prospective cohort; sample selection consecutive (4/6) Prospective cohort; sample selection NR (1/6) Prospective cohort; sample selection by convenience (1/6)	High-quality radiographic imaging (various)	NR; various methodologies utilized	Reported (1/6 studies) Unclear (4/6 studies, including all studies on stress fractures) NR (1/6 studies)	Reported (2/6 studies) Unclear (4/6 studies, including all studies on stress fractures)	High heterogeneity in thermography index test methodologies and diagnostic accuracy. QUADAS assessment by authors indicates moderate-to-high risk of bias in studies on stress fractures.

CT: computed tomography; MRI: magnetic resonance imaging; NR: not reported; QUADAS: Quality Assessment of Diagnostic Accuracy Studies.

^a Note 2 aspects of design: prospective, retrospective or nonconcurrent prospective; sample selection random or consecutive.

^b Note other characteristics that could bias or limit relevance such as use of historical data, evolution of technology, or practice setting.

Study; Subgroup	Initial N (Range)	Final N (Range)	Excluded N	Prevalence of Condition	Clinical Validity (95% Confidence Interval)
					Sensitivity	Specificity	PPV	NPV
Sanchis-Sanchez (2014)7, Stress Fractures	NR	119 (17-84)	NR	NR	NR Range: 45.3-82%	69% (49-85%) Range: 60-100% p-value: 0.17	NR Positive Likelihood Ratio: 2.31 (0.63-8.47) Range: 1.13-6.25 p-value: 0.12	NR Negative Likelihood Ratio: NR Range: 0.22-0.91

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from randomized controlled trials.

Longitudinal Studies

Côrte et al (2019) published pilot data from a longitudinal prospective study on the screening and prevention of muscle injuries in 28 professional Brazilian soccer players.^8, Players were monitored for musculoskeletal imaging during the 2015-2016 seasons with ultrasound. In the second season, a thermographic monitoring regimen was added twice-weekly 48 hours after matches, and an injury prevention protocol was followed based on the results of thermographic imaging. The number of musculoskeletal injuries was compared for both seasons based on these management protocols. The total number of muscle injuries reported decreased from 11 in 2015 to 4 in 2016 (p=0.04). Seven players were on the team roster across both seasons. There was no statistically significant reduction in muscle injury in this subgroup (p=0.06). Limitations of this study are addressed in Tables 10 and 11.

Table 10. Relevance Limitations: Musculoskeletal Injury

Study	Populationa	Interventionb	Comparatorc	Outcomesd	Duration of Follow-Upe
Côrte et al (2019)8,	2. Clinical context is unclear (definition and reporting of muscle injuries are subjective).	2. Version used unclear (therapy utilized in prevention protocol was based on physician discretion and not standardized).	1-2. Classification thresholds for ultrasound not defined; comparison to credible reference standard unclear.	3-5. Key clinical validity outcomes not reported; reclassification of diagnostic or risk categories not reported; adverse events of the test not described.

The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.

^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.

^b Intervention key: 1. Classification thresholds not defined; 2. Version used unclear; 3. Not intervention of interest.

^c Comparator key: 1. Classification thresholds not defined; 2. Not compared to credible reference standard; 3. Not compared to other tests in use for same purpose.

^d Outcomes key: 1. Study does not directly assess a key health outcome; 2. Evidence chain or decision model not explicated; 3. Key clinical validity outcomes not reported (sensitivity, specificity and predictive values); 4. Reclassification of diagnostic or risk categories not reported; 5. Adverse events of the test not described (excluding minor discomforts and inconvenience of venipuncture or noninvasive tests).

^e Follow-Up key: 1. Follow-up duration not sufficient with respect to natural history of disease (true positives, true negatives, false positives, false negatives cannot be determined).

^a Selection key: 1. Selection not described; 2. Selection not random or consecutive (i.e., convenience).

^b Blinding key: 1. Not blinded to results of reference or other comparator tests.

^c Test Delivery key: 1. Timing of delivery of index or reference test not described; 2. Timing of index and comparator tests not same; 3. Procedure for interpreting tests not described; 4. Expertise of evaluators not described.

^d Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.

^e Data Completeness key: 1. Inadequate description of indeterminate and missing samples; 2. High number of samples excluded; 3. High loss to follow-up or missing data.

^f Statistical key: 1. Confidence intervals and/or p values not reported; 2. Comparison with other tests not reported.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

It is not possible to construct a chain of evidence for clinical utility due to the lack of sufficient evidence that the diagnostic accuracy of thermography is at least as high as standard techniques for diagnosing musculoskeletal injuries.

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. There was a lack of a 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 insufficient studies on the impact of thermography on patient management or health outcomes for patients with musculoskeletal injuries.

Temporomandibular Joint Disorder

Clinical Context and Test Purpose

The purpose of using thermography in patients who have TMJ disorder is to inform a decision whether to proceed to appropriate treatment or not.

The question addressed in this portion of the policy is: Does thermography when used to diagnose TMJ disorder, improve the net health outcome compared with standard approaches. Specifically, does the use of thermography improve diagnostic accuracy compared with standard approaches (e.g., clinical examination, imaging with radiography or magnetic resonance imaging), and is this degree of increased accuracy likely to improve health outcomes by leading to earlier diagnosis and treatment?

The following PICOs were used to select literature to inform this policy.

Patients

The relevant population of interest are individuals with TMJ pain.

Interventions

The intervention of interest is thermography. The test would be performed in an outpatient setting.

Comparators

The following tests and practices are currently being used to make decisions about TMJ disorder: standard clinical examination without imaging, diagnostic scales (e.g., Research Diagnostic Criteria for Temporomandibular Disorders [RDC/TMD], Fonseca Anamnestic Index, Anamnestic Index), and other forms of imaging (e.g., with radiography, arthrotomography, magnetic resonance imaging).

Outcomes

The outcomes of interest for diagnostic accuracy include test accuracy and test validity (i.e., sensitivity, specificity). The primary outcomes of interest for clinical utility are a reduction in pain symptoms and improvement in functional ability.

Technically Reliable

Assessment of technical reliability focuses on specific tests and operators and requires a review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this policy and alternative sources exist. This policy focuses on the clinical validity and clinical utility.

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Systematic Reviews

A systematic review by de Melo et al (2019) evaluated the diagnostic accuracy of infrared thermography in TMJ disorder.^9, Nine studies were identified utilizing a variety of comparators. The authors note that while no specific diagnostic tool is currently considered the gold standard for the diagnosis of TMJ disorder, the RDC/TMD diagnostic is commonly used with a reported sensitivity and specificity of 87% and 92%, respectively. Four out of nine studies utilized RDC/TMD, whereas the remaining studies utilized clinical examination or other methods. Characteristics and results of clinical validity for temporomandibular joint disorder diagnostic accuracy in this systematic review are summarized in Tables 12 and 13.

Table 12. Systematic Review: Characteristics of Clinical Validity of Thermography in Temporomandibular Joint Disorder

Study	Study Population	Designa	Reference Standard	Threshold for Positive Index Test	Timing of Reference and Index Tests	Blinding of Assessors	Commentb
de Melo et al (2019)9,	For diagnostic studies: studies reporting on the diagnostic accuracy of infrared thermography vs other diagnostic tests and imaging methods in patients with temporomandibular disorder	NR; sample selection consecutive (1/9 studies) or by convenience (8/9 studies)	RDC/TMD diagnostic, clinical examination, or other imaging methods	NR	NR High-risk of bias based on flow and timing: 4/9 studies Unclear risk of bias based on flow and timing: 5/9 studies	NR	Thermography index test methodologies unclear. Heterogeneity in use of comparator and/or reference standard. Assessment by authors indicates high-risk of bias in all studies.

NR: not reported; RDC/TMD: Research Diagnostic Criteria for Temporomandibular Disorders.

^a Note 2 aspects of design: prospective, retrospective or nonconcurrent prospective; sample selection random or consecutive.

^b Note other characteristics that could bias or limit relevance such as use of historical data, evolution of technology, or practice setting.

Study	Initial N (Range)	Final N (Range)	Excluded N	Prevalence of Condition	Clinical Validity (95% Confidence Interval)
					Sensitivity	Specificity	PPV	NPV
de Melo et al (2019)9,	NR	548 (23-104)	NR	NR	NR Range: 38.5-90%	NR Range: 22.8-95.5%	NR	NR

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from randomized controlled trials.

No studies have been published that evaluate health outcomes in patients with TMJ disorder who were managed with and without thermography.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

It is not possible to construct a chain of evidence for clinical utility due to the lack of sufficient evidence that the diagnostic accuracy of thermography is at least as high as standard techniques for diagnosing TMJ disorder.

Section Summary: TMJ Disorder

A systematic review of studies on thermography for diagnosing TMJ disorder found a wide variation in accuracy compared with other diagnostics. There was a lack of a 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 studies on the impact of thermography on patient management or health outcomes for patients with TMJ disorder.

Miscellaneous Conditions

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,^10,11, surgical site healing in patients who underwent knee replacements,^12, predicting pressure ulcers^13, and pressure ulcer healing,^14, posttreatment pain in patients with coccygodynia,^15, evaluation of allergic conjunctivitis,^16, evaluation of burn depth^17, and association between thermographic findings and burn treatment,^18, detecting cervical lymph node metastasis from oral cavity cancer,^19, monitoring lesions or inflammation in patients with scleroderma,^20,21, detection of vascular obstruction^22, or perforator vessels during surgery,^23,24, diagnosis of lower extremity cellulitis,^25, prediction of infrainguinal bypass surgery,^26, detection of melanoma,^27, detection of contact dermatitis during allergy patch testing,^28,and measuring disease activity in patients with rheumatoid arthritis.^29,

Several studies evaluating the clinical validity of thermography to assess potential complications of the diabetic foot have been conducted. Thermographic images of nondiabetic feet, nonulcerated diabetic feet and ulcerated diabetic feet have been compared.^30,31,32,33,Another study used thermography to diagnose infections in patients admitted with diabetic foot complications.^34, While these studies reported temperature differences between the different feet, none investigated clinical utility, in which health outcomes were compared in patients who were managed with and without thermography results.

Section Summary: Miscellaneous Conditions

For most of these potential indications, there are one or two preliminary studies on each of the indications. Several studies evaluated the clinical validity of thermography in assessing diabetic foot and related complications. For all indications, the studies described temperature gradients or the association between temperature differences and the clinical condition. Due to the small number of studies for each indication, the diagnostic accuracy could not adequately be evaluated. The clinical utility of thermography for these miscellaneous conditions was not investigated in any study.

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. The relevant outcomes are overall survival, disease-specific survival, and test validity. Using histopathologic findings as 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 whether 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, a longitudinal prospective study, and a systematic review. The 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 a lack of a 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 patients with musculoskeletal injuries. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have TMJ disorder who receive thermography, the evidence includes a systematic review. The relevant outcomes are test validity, symptoms, and functional outcomes. A systematic review of studies on thermography for diagnosing TMJ disorder found a wide variation in accuracy compared to other diagnostics. There is a lack of a 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 patients with TMJ disorder. 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, diabetic foot) who receive thermography, the evidence includes diagnostic accuracy studies. The relevant outcomes are test validity, symptoms, and functional outcomes. There are one or two preliminary studies on each of these potential indications for thermography. 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 for any of these miscellaneous conditions has not been investigated in studies considered. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements

European Society of Breast Imaging

A position paper by the European Society of Breast Imaging (2017) and 30 other national breast radiology bodies on screening for breast cancer stated that "screening with thermography or other optical tools as alternatives to mammography is discouraged."^35,

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.^36,

American College of Radiology

The American College of Radiology guidelines for breast cancer screening(revised 2017) do not mention the use of thermography for breast cancer screening.^37,

National Comprehensive Cancer Network

National Comprehensive Cancer Network guidelines on breast cancer screening and diagnosis (v.1.2019) states that: "Current evidence does not support the routine use of thermography or ductal lavage as screening procedures."^38,

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force (2016) 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, magnetic resonance imaging, digital breast tomosynthesis, or other methods) in women identified to have dense breasts on a negative screening mammogram.^39,

Medicare National Coverage

Medicare does not cover thermography. Current Medicare coverage policy states: "Thermography for any indication (including breast lesions which were excluded from Medicare coverage …) is excluded from Medicare coverage because the available evidence does not support this test as a useful aid in the diagnosis or treatment of illness or injury. Therefore, it is not considered effective..."^40,

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this policy are listed in Table 14.

Table 14. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT02705443	Early Identification of Suspected Deep Tissue Injury (sDTI) Utilizing Long-Wave Thermographic Imaging (LWIT)	60	Jun 2017 (unknown)
NCT03089463	Foot Assessment in People with Diabetes: A Quantitative Diagnostic Approach	153	Apr 2020 (recruiting)
NCT03735550	Investigation of the Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts Compared to Standard Diagnostic Methods of Breast Cancer	3000	Jan 2019 (ongoing)
NCT03217214	Investigation of Contact Based Method for Diagnosis of Cardiovascular Disease	100	Sep 2019 (recruiting)
NCT02776995	Tumor Monitoring Using Thermography During Radiation Therapy	80	Dec 2020 (recruiting)
NCT04013711	Quantitative Thermal Imaging to Evaluate Skin Toxicity from Radiation Treatment	200	Aug 2021 (recruiting)
Unpublished
NCT03254095	Thermal and Biomechanical Characterization of Diabetic Foot Patients, Predictors of Skin Temperature, Barefoot Plantar Pressure and Ulceration	100	Sep 2018 (completed)

NCT: national clinical trial.]
________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Thermography

References:
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8. 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). PMID 30687515

9. 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). PMID 30482738

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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. Feb 2012;18(1):88-93. PMID 21605168

12. Romano CL, Logoluso N, Dell'Oro F, et al. Telethermographic findings after uncomplicated and septic total knee replacement. Knee. Jun 2012;19(3):193-197. PMID 21441031

13. 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. PMID 28475447

14. 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

15. 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

16. Hara Y, Shiraishi A, Yamaguchi M, et al. Evaluation of allergic conjunctivitis by thermography. Ophthalmic Res. Mar 5 2014;51(3):161-166. PMID 24603108

17. 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. PMID 26720102

18. Martínez-Jiménez, MM, Ramirez-GarciaLuna, 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). PMID 30427892

19. 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. PMID 29739969

20. 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. PMID 29914516

21. Ranosz-Janicka, II, Lis-Święty, AA, Skrzypek-Salamon, AA, Brzezińska-Wcisło, LL. Detecting and quantifying activity/inflammation in localized scleroderma with thermal imaging. Skin Res Technol, 2018 Jul 22;25(2). PMID 30030915

22. 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. PMID 31067581

23. 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). PMID 30519870

24. 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). PMID 30636085

25. 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). PMID 30003987

26. 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. PMID 31067207

27. 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. PMID 30974494

28. 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). PMID 30598404

29. 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. PMID 29679167

30. 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. PMID 29947290

31. Gatt A, Falzon O, Cassar K, et al. Establishing differences in thermographic patterns between the various complications in diabetic foot disease. Int J Endocrinol. Mar 12 2018;2018:9808295. PMID 29721019

32. 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. PMID 24124938

33. 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. PMID 30738090

34. 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

35. 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. PMID 27807699

36. 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., 2019 Apr 9. PMID 30959525

37. 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). PMID 29101979

38. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer Screening and Diagnosis. Version 1.2019. 2019; https://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf. Accessed July 22, 2019.

39. U.S. Preventive Services Task Force. Breast Cancer: Screening. 2016; https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/breast-cancer-screening1. Accessed July 22, 2019.

40. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination for Thermography (220.11). 1992; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=164&ncdver=1&DocID=220.11. Accessed July 22, 2019.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

93799