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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Dermatoscopy and Surveillance Photography for Detection of Melanoma - Commercial Medical Management Guideline TITLE: Digital Infrared Thermal Imaging Authorized By: Medical Management Guideline Committee

Adoption Date: 08/11/09 Revision Date:

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.

Member benefit coverage and limitations may vary based on the member’s benefit plan.

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supersede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

–  –  –

Description After evaluating relevant benefit document language (exclusions or limitations), refer to Coverage sections of this document to determine coverage.

This policy describes the use of digital infrared thermal imaging, a technology that provides an image of the body's heat emissions. This type of imaging has been investigated as a method for diagnosis and/or prognosis of a number of different conditions, including breast cancer, Raynaud's phenomenon, neurological disorders, orofacial pain and disorders, Digital Infrared Thermal Imaging - Commercial Medical Management Guideline musculoskeletal damage, and undescended testes Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Coverage Rationale

Digital infrared thermal imaging is unproven as a method of diagnosing and/or evaluating the following:

• breast cancer,

• Raynaud's phenomenon,

• neurological disorders,

• orofacial pain and disorders,

• musculoskeletal damage, or

• undescended testes There is insufficient evidence to support the use of digital infrared thermal imaging (DITI) as a sole or adjunct diagnostic procedure for breast cancer. Specificity of DITI for this indication is low and there are no data regarding the relative accuracy of DITI compared with other adjunct methods of breast cancer diagnosis. There is also insufficient evidence to support the use of DITI for the diagnosis of Raynaud's phenomenon, neurological disorders, orofacial pain and disorders, musculoskeletal damage to the foot, and localization of undescended testes. The available evidence is limited and weak, and standards for image evaluation and cut-off values that would allow clinical recommendations based on this technology have not been established for any of the above indications.

Regulatory Requirements

U.S. Food and Drug Administration (FDA):

The FDA regulates telethermographic systems such as those used for breast cancer detection as Class II devices. Over 30 of these systems have been approved via the FDA 510 (k) process.

Systems include, but are not limited to, the following: Telesis Digital Infrared Thermal Imaging System-Spectrum 9000MB (Telesis Technologies Inc, His-Chih City, Taiwan; June 7, 2002) for the adjunctive detection of breast cancer or other uses; Dorex Spectrum 9000MB Thermography System (DOREX Inc, Orange, CA; November 14, 2002) for the adjunctive diagnosis and/or follow-up in areas of orthopedics, pain management, neurology, and diabetic foot care; Mark I Thermal Imager (IX-DR Inc, Howell, MI; February 11, 2003) as an adjunctive medical imaging modality; MHS 7000 Thermal Imaging System (Micro Health Systems Inc, Parkland, FL; March 26, 2003) for providing thermal images of the human body in all age groups from adult to pediatric and neonatal; IRIS-IV Infrared Imaging System (Biocare Medical Technology LLC, Woodbury, CT; April 16, 2003), indicated for the viewing and documenting of temperature differences prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting. (Accessed October 23, 2008).





Research Evidence

Background:

Digital infrared thermal imaging (DITI), also called thermography or temperature gradient studies, involves imaging of the body's vascular heat emissions. The most common parameters considered to be indicative of illness and of potentially diagnostic value are: mean temperature, spatial thermal variations, and temporal thermal variations, including the frequency of thermal variations. These irregularities in the body surface's thermal patterns occur in response to vasomotor dysfunction. It has therefore been suggested that DITI may be a prognostic tool for the detection, diagnosis, and/or prognosis of peripheral vascular and neurological disorders. In addition, the efficacy of DITI for disease diagnosis and prognosis is being evaluated in many other medical disciplines such as oncology, dentistry, urology, and dermatology.

Digital Infrared Thermal Imaging - Commercial Medical Management Guideline This policy summarizes the available clinical trial evidence regarding DITI for the diagnosis of breast cancer, Raynaud's phenomenon, neurological disorders, orofacial disorders, and undescended testes.

Breast Cancer may be detected by mammography, physical examination, and patient self-breast examination at an early, curable stage. In recent years, the development of alternative breast imaging techniques for early breast cancer detection, including positron emission tomography, computed tomography, magnetic resonance imaging, transillumination diaphanography, ultrasound, digital subtraction angiography, and DITI, has received increasing attention. Breast cancer diagnosis using DITI is based on a thermogram of abnormal heat distribution patterns and so-called hot spots. The mechanism underlying the DITI diagnostic criteria for breast cancer diagnosis is not yet understood. Physiologic features related to tumor tissue that may contribute to the thermal signal are local increases in blood flow, angiogenesis, and the release of vasoactive mediators.

Raynaud's phenomenon (RP) is characterized by episodic color and temperature changes of the fingers and/or toes on exposure to cold or emotional stress. Diagnosis and staging of RP is based on subjective scoring systems. DITI has been proposed as an objective diagnostic tool to assess the severity of RP and to distinguish primary from secondary RP using thermal abnormalities in the fingers in response to a cold provocation test as an objective diagnostic measure.

DITI has also been used to demonstrate thermal abnormalities in patients with sympathetic nerve damage. The rationale for this is that temperature changes at the body surface are regulated by the sympathetic nervous system. In some types of nerve damage, such as encountered in peripheral neuropathy, disc herniations, and some orofacial disorders, the skin's vasomotor response is affected. Therefore, DITI may be able to identify neuronal damage based on detection of thermal abnormalities on the body surface. DITI is being evaluated as a means to provide differential diagnosis in these patients as an alternative to other diagnostic modalities such as magnetic resonance imaging or positron emission tomography.

Other applications of DITI that have been investigated include use as a complementary imaging technique for the diagnosis of undescended testes and for the noninvasive assessment of stress-induced musculoskeletal damage.

Research Evidence:

No new studies on the use of digital infrared thermal imaging (DITI) were identified in the published, peer-reviewed, medical literature.

Diagnosis of breast cancer: In a prospective, controlled study by Ohashi and Uchida, 2000, (n = 828) an overall diagnostic accuracy of 82% and a false-positive rate of 41% was achieved. In a prospective, multicenter, blinded, study, Parisky et al., 2003, (n = 769) reported sensitivity, specificity, positive predictive value, and a negative predictive value of 97%, 14%, 24%, and 95%, respectively. Lack of statistical analysis and exclusion of a large number of patients from data analysis compromised the quality of the evidence in both studies.

Diagnosis and staging of Raynaud's phenomenon: Three studies of 31 to 58 patients with primary or secondary Raynaud's phenomenon were identified (Cherkas et al., 2001, Coughlin et al., 2001, Merla et al., 2002). DITI was conducted in a room with ambient temperature. The patient was asked to rest in the imaging room to equilibrate the patient's body temperature to imaging temperatures. A cold provocation test (CPT) was administered by immersing the patient's latexgloved hands in cold water. The patients' hands were imaged pre- and post-CPT and during the rewarming period. In these studies, sensitivity of DITI for RP ranged from 86% to 100%, with a specificity of 84 to 100%. Cherkas et al., 2001, correlated DITI results to Taylor-Pelmear (T-P) staging in patients with RP secondary to vibration induced white finger. In this study, no significant difference was found between the two most advanced stages, T-P III and IV. Lack of blinding, small sample size, insufficient statistical analysis, and differences in imaging and data interpretation compromise the quality of the evidence.

Digital Infrared Thermal Imaging - Commercial Medical Management Guideline

Diagnosis of neurological disorders: The studies included 35 to 165 patients with nerve damage including lumbosacral radiculopathy (Harper et al., 1991), peripheral neuropathy (Park et al., 1994), and cervical disc herniation (Zhang et al., 1994). In all studies, temperature differences between corresponding body sites served as the primary outcome measure. In these studies, DITI achieved a sensitivity of 78% to 94% and a specificity of 20% to 44% for the diagnosis of lumbosacral radiculopathy. The positive predictive value (45% to 50%) was significantly lower than that of electromyography (100%) and computed tomography myelography (80%) (Harper et al., 1991). DITI demonstrated significant temperature changes in localized body surface thermal patterns (thermatomes) in patients with cervical disc herniation depending on the level of disc protrusion (Zhang et al., 1999). Small sample sizes, heterogeneous study populations, insufficiently defined inclusion and exclusion criteria, a lack of randomization, and, in some cases, lack of blinding compromised the quality of the evidence.

Diagnosis of orofacial pain and other disorders: The studies included 40 to 328 patients with orofacial pain or disorders including inferior alveolar nerve deficit, infraorbital nerve injury, neuropathic facial pain, trigeminal neuralgia, and temporal mandibular joint (TMJ) dysfunction (Gratt et al., 1995, McGimpsey et al., 2000, Graff-Radford et al., 1995, Canavan and Gratt, 1995, Gratt et al., 1996). Outcome measures included temperature differences between the affected and unaffected side of the face and comparisons of thermograms of age- and sex-matched healthy volunteers. In these studies, DITI achieved an overall accuracy of 89%, 85% sensitivity, and 92% specificity for the diagnosis of TMJ dysfunction (Canavan and Gratt, 1995, Gratt et al., 1996). A loss of facial thermal symmetry was observed for patients with sympathetically independent traumatic trigeminal neuralgia with peripheral facial neuropathy (Graff-Radford et al., 1995). Contradictory results were obtained for the diagnosis of infraorbital nerve injury (Gratt et al., 1995, McGimpsey et al., 2000). Small sample sizes, heterogeneous study populations, insufficiently defined inclusion and exclusion criteria, a lack of randomization, and, in some cases, lack of blinding compromised the quality of the evidence.

Diagnosis of undescended testes: The study included 28 patients with 36 undescended testes (Lai et al., 1998). Outcome measures included temperature differences between affected and unaffected side and diagnostic rate compared with ultrasonogram and palpation. In this study, DITI achieved an overall diagnostic rate of 54.5%. This rate did not significantly differ from ultrasonography (65.7%) or palpation (63.9%). Small sample size, lack of a control group, and insufficiently defined patient selection criteria compromised the quality of the evidence.

Diagnosis of stress-induced musculoskeletal damage to the foot: The study included 90 male study participants, all selected from a large cohort of military basic trainees (DiBenedetto et al., 2002). Thirty patients were identified by bone scan as having stress bone fractures, 30 volunteers were actively participating in military training, and 30 were new recruits prior to military training. Outcome measures included differences in thermal symmetry of the plantar aspect of the foot of patients with stress bone fractures compared with healthy control subjects. In this study, patients with stress bone fractures presented with statistically significant differences in thermal patterns of the plantar aspect of the foot. A small sample size compromised the quality of this study.



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