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Thermography

Policy Number: MP-436

Latest Review Date: September 2020

Category: Radiology

Policy Grade: B

 

POLICY:

The use of all forms of thermography is considered not medically necessary and investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Thermography is a noninvasive imaging technique that is intended to measure temperature distribution of organs and tissues. The visual display of this temperature information is known as a thermogram. Thermography has been proposed as a diagnostic tool for planning and evaluation of treatment effects for a variety of conditons.

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.

KEY POINTS:

The most recent literature review was performed through August 4, 2020.

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 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, a longitudinal prospective study, and a systematic review. The relevant outcomes are test accuracy and 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 consistent reference standard. This evidence does not permit conclusions 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. 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 (eg, herpes zoster, pressure ulcers, diabetic foot) who receive thermography, the evidence primarily includes diagnostic accuracy studies. Outcomes in these studies are test validity, symptoms, and functional outcomes. Most studies assessed temperature gradients or the association between temperature differences and the clinical condition. Due to the small number of studies for each indication, diagnostic accuracy could not adequately be evaluated. The clinical utility of thermography has only been considered in one study of of diabetic foot ulcers. For any of these other miscellaneous conditions, the clinical utility of thermography has not been investigated. The evidence is insufficient to determine the effects of the technology on health outcomes.

PRACTICE GUIDELINES AND POSITION STATEMENTS

European Society of Breast Imaging et al

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

American College of Physicians

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

American College of Radiology (ACR):

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

National Comprehensive Cancer Network

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

U.S. Preventative Services Task Force Recommendations

The 2016 U.S. Preventive Services Task Force recommendations on breast cancer screening do not mention thermography. Additionally, there is insufficient evidence for the use of adjunctive screening methods for breast cancer (ultrasonography, magnetic resonance imaging, digital breast tomosynthesis, or other methods) in women identified to have dense breasts on a negative screening mammogram.

KEY WORDS:

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

APPROVED BY GOVERNING BODIES:

A number of thermographic devices have been cleared for marketing by the Food and Drug Administration through the 510(k) process. Food and Drug Administration product codes: LHQ, FXN. Devices with product code LHQ may only be marketed for adjunct use. Devices with product code FXN do not provide a diagnosis or therapy. Examples of these devices are shown in Table 1.

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

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

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:

93799

Unlisted cardiovascular service or procedure

93740

Temperature Gradient Studies

REFERENCES:

  1. Agazzi A, Fadanelli G, Vittadello F, et al. Reliability of LoSCAT score for activity and tissue damage assessment in a large cohort of patients with Juvenile Localized Scleroderma. Pediatr Rheumatol Online J. Jun 18 2018; 16(1):37.

  2. Al Shakarchi, JJ, Inston, NN, Dabare, DD, Newman, JJ, Garnham, AA, Hobbs, SS, Wall, MM. Pilot study on the use of infrared thermal imaging to predict infrainguinal bypass outcome in the immediate post-operative period. Vascular, 2019 May 9;1708538119847391.

  3. American 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):523-5. www.aan.com/professionals/practice/pdfs/gl0053.pdf.

  4. American College of Obstetricians and Gynecologists (ACOG). Mammography and Other Screening Tests for Breast Problems. 2015. Accessed August 10, 2016.

  5. American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening: ACOG practice bulletin; no. 122. Available online at: www.guideline.gov.

  6. American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2003. 12 p. (ACOG practice bulletin; no. 42). The currency of the guideline was reaffirmed in 2006.

  7. American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2003. 12 p. (ACOG practice bulletin; no. 42). The currency of the guideline was reaffirmed in 2006.

  8. American College of Radiology. ACR Appropriateness Criteria® breast cancer screening: 2012. Available online at: www.guideline.gov.

  9. American College of Radiology. ACR Appropriateness Criteria for Myelopathy: 2011. Available online at: www.guideline.gov.

  10. American College of Radiology. Appropriateness Criteria for Acute Low Back Pain – Radiculopathy. Radiology 2000; 215(suppl):479-85. www.acr.org/s_acr/bin.asp?CID=1205&DID=11801&DOC=FILE.PDF.

  11. American College of Radiology. Appropriateness Criteria for Suspected Lower Extremity Deep Vein Thrombosis. www.acr.org/s_acr/bin.asp?CID=1208&DID=11746&DOC=FILE.PDF.

  12. American Medical Association (AMA) policy statement. H-175.988 Thermography Update. www.ama-assn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/HnE/H-175.988.HTM.

  13. 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).

  14. 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.

  15. Balbinot LF, Canani LH, Robinson CC et al. Plantar thermography is useful in the early diagnosis of diabetic neuropathy. Clinics (Sao Paulo) 2012; 67(12):1419-25.

  16. 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.

  17. Brkljacic B, Miletic D, Sardanelli F. Thermography is not a feasible method for breast cancer screening. Collegium antropologicum 2013; 37(2):589-93.

  18. 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).

  19. 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).

  20. Council on Chiropractic Practice. Subluxation chiropractic practice. 2013. Available online at: www.guideline.gov/content.aspx?id=47342.

  21. Council on Chiropractic Practice. Vertebral Subluxation in Chiropractic Practice: 2008. Available online at: www.guideline.gov/content.aspx?id=13617&search=vertebral+subluxation.

  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.

  23. 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).

  24. 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.

  25. Fitzgerald A, Berentson-Shaw J. Thermography as a screening and diagnostic tool: a systematic review. N Z Med J 2012; 125(1351):80-91.

  26. 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.

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

  28. Han SS, Jung CH, Lee SC et al. Does skin temperature difference as measured by infrared thermography within 6 months of acute herpes zoster infection correlate with pain level? Skin Res Tech 2010; 16(2):198-201.

  29. Hara Y, Shiraishi A, Yamaguchi M et al. Evaluation of Allergic Conjunctivitis by Thermography. Ophthalmic research 2014; 51(3):161-66.

  30. 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.

  31. International Research Foundation for RSD/CRPS. Reflex sympathetic dystrophy/complex regional pain syndrome. Third ed. Tampa (FL): International Research Foundation for RSD/CRPS; 2003.

  32. 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.

  33. Kolaric D, Herceg Z, Nola IA et al. Thermography--a feasible method for screening breast cancer? Collegium antropologicum 2013; 37(2):583-8.

  34. 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.

  35. 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).

  36. 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.

  37. Mainiero MB, Lourenco A, Mahoney MC, et al. ACR Appropriateness Criteria Breast Cancer Screening. J Am Coll Radiol. Nov 2016; 13(11s):R45-r49.

  38. 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).

  39. Martínez-Jiménez, MM, Ramirez-Garcia Luna, JJ, Kolosovas-Machuca, EE, Drager, JJ, González, FF. Development and validation of an algorithm to predict the treatment modality of burn wounds using thermographic scans: Prospective cohort study. PLoS ONE, 2018 Nov 15;13(11).

  40. Morales-Cervantes, A, Kolosovas-Machuca, ES, Guevara, E, Maruris Reducindo, MM, Bello Hernández, AB, Ramos García, M, González, FJ. An automated method for the evaluation of breast cancer using infrared thermography. EXCLI J, 2018 Dec 20;17:989-998.

  41. 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.

  42. 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.

  43. Neal, CH, Flynt, KA, Jeffries, DO, Helvie, MA. Breast Imaging Outcomes following Abnormal Thermography. Acad Radiol, 2018 Mar;25(3):273-278.

  44. 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.

  45. Omranipour R, Kazemian A, Alipour S, et al. Comparison of the accuracy of thermography and mammography in the detection of breast cancer. Breast Care (Basel). Aug 2016; 11(4):260-264.

  46. 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.

  47. 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.

  48. 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).

  49. Rassiwala M, Mathur P, Mathur R, et al. Evaluation of digital infra-red thermal imaging as an adjunctive screening method for breast carcinoma: a pilot study. Int J Surg. Dec 2014; 12(12):1439-1443.

  50. 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):663-7.

  51. Romano CL, Logoluso N, Dell’Oro F et al. Telethermographic findings after uncomplicated and septic total knee replacement. Knee 2012; 19(3):193-7.

  52. Sanchis-Sanchez E, Vergara-Hernandez C, Cibrian RM, et al. Infrared thermal imaging in the diagnosis of musculoskeletal injuries: a systematic review and meta-analysis. AJR Am J Roentgenol. Oct 2014; 203(4):875-882.

  53. 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.

  54. 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):449-57.

  55. Shada AL, Dengel LT, Petroni GR et al. Infrared thermography of cutaneous melanoma metastases. J Surg Res 2012.

  56. 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.

  57. 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).

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

  59. 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.

  60. Vreugdenburg TD, Willis CD, Mundy L et al. A systematic review of elastography, electrical impedance scanning and digital infrared thermography for breast cancer screening and diagnosis. Breast Cancer Res Treat 2013; 137(3):665-676.

  61. Work Loss Data Institute. Low back - lumbar & thoracic (acute & chronic). 2011. Available online at: www.guideline.gov/content.aspx?id=33184&search=work+loss+institute.

  62. Work Loss Data Institute. Neck and upper back (acute & chronic). 2011. Available online at: www.guideline.gov.

  63. Wozniak K, Szyszka-Sommerfeld L, Trybek G, et al. Assessment of the sensitivity, specificity, and accuracy of thermography in identifying patients with TMD. Med Sci Monit. 2015; 21:1485-1493.

  64. Wu CL, Yu KL, Chuang HY, et al. The application of infrared thermography in the assessment of patients with coccygodynia before and after manual therapy combined with diathermy. J Manipulative Physiol Ther 2009; 32(4):287-93.

POLICY HISTORY:

Medical Policy Group, June 2010 (3)

Medical Policy Administration Committee, July 2010

Available for comment July 2-August 16, 2010

Medial Policy Group, December 2010 (2)

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

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

Medical Policy Panel, May 2013

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

Medical Policy Panel, May 2014

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

Medical Policy Panel, May 2015

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

Medical Policy Panel, September 2016

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

Medical Policy Panel, September 2017

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

Medical Policy Panel, September 2018

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

Medical Policy Panel, September 2019

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

Medical Policy Panel

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

 

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

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

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

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

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

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

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

3. The technology must improve the net health outcome;

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

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

 

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

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

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

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

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