MEDICAL POLICY

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Thermography

Number 6.01.12*

Effective Date July 31, 2014

Revision Date(s) 07/14/14; 07/08/13; 07/10/12; 07/12/11; 06/09/09;03/11/08; 08/08/06; 08/09/05; 10/12/04; 04/15/03; 01/97

Replaces N/A

*Medicare has a policy.

Policy

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The use of all forms of thermography is considered investigational.

Related Policies

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8.03.501

Chiropractic Services

Policy Guidelines

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Coding

CPT

93799

Unlisted cardiovascular service or procedure

Description

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Thermography is a noninvasive imaging technique that is intended to measure temperature distribution in organs and tissues. The visual display of this temperature information is known as a thermogram. Thermography has been proposed to use with a variety of conditions as a diagnostic tool, for treatment planning and to evaluate the effects of treatment.

Background

Thermography involves the use of an infrared scanning device and can include various types of telethermographic infrared detector images and heat-sensitive cholesteric liquid crystal systems. Infrared radiation from the skin or organ tissue reveals temperature variations by producing brightly colored patterns on a liquid crystal display. Interpretation of the color patterns is thought to assist in the diagnosis of many disorders such as complex regional pain syndrome (CRPS, previously known as reflex sympathetic dystrophy), breast cancer, Raynaud phenomenon, digital artery vasospasm in hand-arm vibration syndrome, peripheral nerve damage following trauma, impaired spermatogenesis in infertile men, degree of burns, deep vein thrombosis, gastric cancer, tear-film layer stability in dry-eye syndrome, Frey syndrome, headaches, low-back pain, and vertebral subluxation.

Thermography may also assist in treatment planning and procedure guidance 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.

Regulatory Status

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. FDA determined that this device was substantially equivalent to existing devices for use in quantifying and visualizing skin temperature changes. Its indicated use is as an aid in diagnosis and follow-up therapy in areas such as orthopedics, pain management, neurology, and diabetic foot care. This type of device is also known as a telethermographic system. FDA product code: LHQ.

In 2003, several telethermographic cameras (Series A, E, P, S) by Flir Systems (McCordsville, IN) were cleared for marketing by 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, three new or updated thermography devices received 510(k) marketing clearance from FDA based on demonstrating substantial equivalence to existing products. FDA product code: LHQ.

Scope

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Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

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N/A

Rationale

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Literature Review

This policy was originally created in 1996 and was updated regularly with searches of the MEDLINE database. The most recent literature review was conducted through April 1, 2014. Following is a summary of the key literature to date:

No published studies have demonstrated how the results of thermography can be used to enhance patient management and/or improve patient health outcomes Breast cancer is the potential application of thermography with the most published literature. Two systematic reviews of the published literature were identified. A 2012 systematic review 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. (1) In the screening study, more than 10,000 women were invited to participate, and sample sizes in the diagnosis studies ranged from 63 to 2,625 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 identified 8 studies on thermography for diagnosis of breast cancer that included a valid reference standard. (2) Six of the 8 studies, with sample sizes between 29 and 769 patients, included women scheduled for biopsy. The sensitivity of thermography in the individual studies ranged from 25% to 97% and specificity ranged from 12% to 85%. Study findings were not pooled. For example, a 2008 study by Arora et al. included 92 patients presenting for breast biopsy. (3) When used in a screening mode (any positive reading was considered abnormal) for breast cancer, the sensitivity of thermography was 97% and specificity was 12%; when evaluated in a clinical mode (the lesion in question was used to determine an abnormal score), sensitivity was 90% and specificity was 44%. A more recent example is a 2013 study from Croatia by Kolaric et al. in which 26 patients were evaluated with mammography and thermography before breast cancer surgery. (4) The sensitivity and specificity of mammography were 85% and 84%, respectively, and of thermography were 100% and 79%, respectively. Limitations of the Kolaric study include its small sample size, unclear patient selection criteria, and unblinded analysis of test findings. (5)

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. For example, a study by Krumova et al. reported on skin temperature measurements in 22 patients with complex regional pain syndrome (CRPS), 18 with non-CRPS pain, and 23 healthy controls. (6) Using long-term thermography, there was asymmetry in limb temperature in the CRPS group and, to some extent, in non-CRPS pain patients that was not seen in healthy controls. However, the significance of these results is uncertain. Some of the differences could be due to effects of medication, e.g., antiseizure or antidepressant medications. In addition, the similarity of some findings between those with CRPS and non-CRPS pain limits applicability for use in diagnosis. Another example is a study published by Shada et al. that addressed the use of infrared thermography for differentiating between a melanoma metastasis and benign cutaneous lesions. (7) The study included 74 subjects with 251 palpable skin lesions. Thermographic images were taken of the lesions and diagnosis was confirmed by biopsy or clinical diagnosis. The sensitivity and specificity of thermography varied by lesion size. For lesions between 0 and 5 mm (n=40), the sensitivity was 39% and specificity was 100%. For lesions between 5 and 15 mm (n=46), the sensitivity was 0.58% and the specificity was 98%. Sensitivity and specificity were 95% and 100%, respectively, for lesions between 15 and 30 mm and 78% and 89%, respectively, for lesions greater than 30 mm.

Examples of other studies on thermography, all conducted outside of the United States, include evaluating the association between thermographic findings and post-herpetic neuralgia in patients with herpes zoster, (8, 9), surgical site healing in patients who underwent knee replacements, (10) ulcer healing in patients with pressure ulcers, (11) post-treatment pain in patients with coccygodynia, (12) evaluation of allergic conjunctivitis, (13) and early diagnosis of diabetic neuropathy. (14)

Summary

There is insufficient evidence to support the use of thermography, a noninvasive infrared scanning device, for screening, diagnosis, treatment planning, or treatment monitoring. Studies are lacking that thermography can accurately diagnose any condition or improve the accuracy of another diagnostic tool. Moreover, there are no published studies evaluating whether use of thermography in patient management, such as to select a treatment or determine treatment effectiveness, improves health outcomes. Thus, thermography is considered investigational.

Practice Guidelines and Position Statements

American College of Radiology: Their 2011 statement on myelopathy states that there is no high-quality evidence in support of thermography. (15)

American College of Radiology: Their 2012 statement on breast imaging states that there is insufficient evidence to support the use of thermography for breast cancer screening. (16)

American College of Obstetricians and Gynecologists: Their 2011 practice bulletin on breast cancer did not address thermography as a screening option. (17)

Council on Chiropractic Practice: In 2013 they issued an updated clinical practice guideline which includes the following recommendation on skin temperature instrumentation, (18) “temperature reading devices employing thermocouples, infrared thermometry or thermography (liquid crystal, telethermography, multiple IR detectors, etc.) may be used to detect temperature changes in spinal and paraspinal tissues related to vertebral subluxation.” The recommendation remains unchanged from 2008. (19) It was based on expert opinion and literature support in the form of observational, pre-post, and/or case studies but not controlled studies.

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. (20, 21)

Medicare National Coverage

Medicare does not consider thermography to be eligible for coverage. The Medicare coverage policy, current as of April 2011 states, “Thermography for any indication (including breast lesions which were excluded from Medicare coverage on July 20, 1984) 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. This exclusion was published as a CMS Final Notice in the "Federal Register" on November 20, 1992.”

References

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  1. Fitzgerald A, Berentson-Shaw J. Thermography as a screening and diagnostic tool: a systematic review. N Z Med J 2012; 125(1351):80-91.
  2. 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 research and treatment 2013; 137(3):665-76.
  3. 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):523-6.
  4. Kolaric D, Herceg Z, Nola IA et al. Thermography--a feasible method for screening breast cancer? Collegium antropologicum 2013; 37(2):583-8.
  5. Brkljacic B, Miletic D, Sardanelli F. Thermography is not a feasible method for breast cancer screening. Collegium antropologicum 2013; 37(2):589-93.
  6. 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-Jan):8-22.
  7. Shada AL, Dengel LT, Petroni GR et al. Infrared thermography of cutaneous melanoma metastases. The Journal of surgical research 2012.
  8. Han SS, Jung CH, Lee SC et al. Does skin temperature difference as measured by infrared thermography within 6 months of acute herpes zoster infection correlate with pain level? Skin Res Technol 2010; 16(2):198-201.
  9. Park J, Jang WS, Park KY et al. Thermography as a predictor of postherpetic neuralgia in acute herpes zoster patients: a preliminary study. Skin Res Technol 2012; 18(1):88-93.
  10. Romano CL, Logoluso N, Dell'Oro F et al. Telethermographic findings after uncomplicated and septic total knee replacement. The Knee 2012; 19(3):193-7.
  11. Nakagami G, Sanada H, Iizaka S et al. Predicting delayed pressure ulcer healing using thermography: a prospective cohort study. J Wound Care 2010; 19(11):465-72.
  12. Wu CL, Yu KL, Chuang HY et al. The application of infrared thermography in the assessment of patients with coccygodynia before and after manual therapy combined with diathermy. J Manipulative Physiol Ther 2009; 32(4):287-93.
  13. Hara Y, Shiraishi A, Yamaguchi M et al. Evaluation of Allergic Conjunctivitis by Thermography. Ophthalmic research 2014; 51(3):161-66.
  14. Balbinot LF, Canani LH, Robinson CC et al. Plantar thermography is useful in the early diagnosis of diabetic neuropathy. Clinics (Sao Paulo, Brazil) 2012; 67(12):1419-25.
  15. ACR Appropriateness Criteria®. ACR Appropriateness Criteria® myelopathy: 2011. Available online at: www.guideline.gov. Last accessed June, 2014.
  16. ACR Appropriateness Criteria®. ACR Appropriateness Criteria® breast cancer screening: 2012. Available online at: www.guideline.gov. Last accessed June, 2014.
  17. American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening: ACOG practice bulletin; no. 122. Available online at: www.guideline.gov. Last accessed March, 2014.
  18. Council on Chiropractic Practice. Subluxation chiropractic practice. 2013. Available online at: http://www.guideline.gov/content.aspx?id=47342. Last accessed June, 2014.
  19. Council on Chiropractic Practice. Vertebral subluxation in chiropractic practice: 2008. Available online at: http://www.guideline.gov/content.aspx?id=13617&search=vertebral+subluxation. Last accessed June, 2014.
  20. Work Loss Data Institute. Neck and upper back (acute & chronic): 2011. Available online at: www.guideline.gov. Last accessed March, 2014.
  21. Work Loss Data Institute. Low back - lumbar & thoracic (acute & chronic): 2011. Available online at: http://www.guideline.gov/content.aspx?id=33184&search=work+loss+institute. Last accessed June, 2014

Coding

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Codes

Number

Description

CPT

93799

Unlisted cardiovascular service or procedure

Type of Service

Radiology

 

Place of Service

Inpatient/
Outpatient

Physician's Office

 

Appendix

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N/A

History

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Date

Reason

01/97

Add to Radiology Section - New Policy

04/15/03

Replace Policy - Policy updated with additional references; no change in policy statement.

10/12/04

Replace Policy - Literature review update on MEDLINE for the period of June 2003-May 2004; updated clinical guideline information; policy statement unchanged.

08/09/05

Replace Policy - Policy updated with literature review; no clinical trial information addressing health outcomes found. References added; policy statement unchanged.

06/30/06

Update Scope and Disclaimer - No other changes.

08/08/06

Replace Policy - Policy reviewed with literature search; references updated; policy statement unchanged.

11/13/07

Cross reference updated - No other changes.

03/11/08

Replace Policy - Policy updated with literature search; no change to policy statement. References added.

06/09/09

Replace Policy - Policy updated with literature search; no change to policy statement. References added.

07/12/11

Replace Policy - Policy updated with literature search through March 2011. Reference numbers 6, 7 and 8 added; other references renumbered/removed. No change in policy statement. ICD-10 codes added to policy.

02/09/12

The CPT code 937240 was removed from the policy.

07/20/12

Replace policy. Policy updated with literature search through March 2012. References 1 and 7 added; other references renumbered/removed. Policy statement is unchanged.

09/25/12

Update Coding Section – ICD-10 codes are now effective 10/01/2014.

07/24/13

Replace policy. Rationale updated based on literature review through April 2013. ACR 2012 statement on breast imaging states that there is insufficient evidence to support the use of thermography for breast cancer screening. References 2, 5, 11 and 13 added; others renumbered/removed. Policy statement unchanged.

03/11/14

Coding Update. Codes 88.81, 88.82, 88.83, 88.84, 88.85, 88.86, 88.89 were removed per ICD-10 mapping project; these codes are not utilized for adjudication of policy.

07/31/14

Annual Review. Policy updated with literature review through April 1, 2014. References 4, 5, 13 and 18 added. Policy statement unchanged.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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