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Electromagnetic Navigational Bronchoscopy

Policy Number: MP-400

Latest Review Date:  June 2022

Category:  Surgery                                                                 

POLICY:

When flexible bronchoscopy alone, or with endobronchial ultrasound, are considered inadequate to accomplish the diagnostic or

interventional objective, electromagnetic navigation bronchoscopy (ENB) may be considered medically necessary to:

  • establish a diagnosis of suspicious peripheral pulmonary lesion(s) or
  • place fiducial markers within lung tumor(s) prior to treatment

Electromagnetic navigation bronchoscopy is considered investigational for use with flexible bronchoscopy for the diagnosis of mediastinal lymph nodes as well as all other uses not covered above.

DESCRIPTION OF PROCEDURE OR SERVICE:

Electromagnetic navigation bronchoscopy (ENB) is intended to enhance standard bronchoscopy by providing a 3-dimensional roadmap of the lungs and real-time information about the position of the steerable probe during bronchoscopy. The purpose of ENB is to allow navigation to distal regions of the lungs so that suspicious lesions can be biopsied and to allow for placement of fiducial markers.

Pulmonary Nodules

Pulmonary nodules are identified on plain chest radiographs or chest computed tomography (CT) scans. Although most nodules are benign, some are cancerous, and early diagnosis of lung cancer is desirable because of the poor prognosis when it is diagnosed later.

Diagnosis

Lung cancer is the leading cause of cancer-related death in the U.S., with an estimated 236,740 new cases and 130,180 deaths due to the disease in 2022. The stage at which lung cancer is diagnosed has the greatest impact on prognosis. Localized disease confined to the primary site has a 60% relative 5-year survival but accounts for only 22% of lung cancer cases at diagnosis. Mortality increases sharply with advancing stage and metastatic lung cancer has a relative 5-year survival of 6%. In addition to tumor stage, other factors such as age, sex, race/ethnicity, and performance status are independent prognostic factors for survival in patients with lung cancer. The average age at diagnosis is about 70 years and most people diagnosed with lung cancer are 65 years of age or older. The lifetime risk of lung cancer is approximately 1 in 15 for men and 1 in 17 for women, with an increased risk in people who smoke. Rates of lung cancer have been dropping among men over the past few decades, but only for about the last decade in women. Black men are about 12% more likely to develop lung cancer compared to White men, although Black men are less likely to develop small cell lung cancer when compared to White men. Among women, the rate of lung cancer is about 16% lower for Black versus White women.

The method used to diagnose lung cancer depends on a number of factors, including lesion size, shape and location, as well as the clinical history and status of the patient. Peripheral lung lesions and solitary pulmonary nodules (most often defined as asymptomatic nodules <6 mm) are more difficult to evaluate than larger, centrally located lesions. There are several options for diagnosing them; none of the methods is ideal for safely and accurately diagnosing malignant disease. Sputum cytology is the least invasive approach. Reported sensitivity rates are relatively low and vary widely across studies; sensitivity is lower for peripheral lesions. Sputum cytology, however, has a high specificity; and a positive test may obviate the need for more invasive testing. Flexible bronchoscopy, a minimally invasive procedure, is an established approach to evaluate pulmonary nodules. The sensitivity of flexible bronchoscopy for diagnosing bronchogenic carcinoma has been estimated at 88% for central lesions and 78% for peripheral lesions. For small peripheral lesions (<1.5 cm in diameter), the sensitivity may be as low as 10%. The diagnostic accuracy of transthoracic needle aspiration for solitary pulmonary nodules tends to be higher than that of bronchoscopy; the sensitivity and specificity are both approximately 94%. A disadvantage of transthoracic needle aspiration is that a pneumothorax develops in 11% to 25% of patients, and 5% to 14% require insertion of a chest tube. Positron emission tomography scans are also highly sensitive for evaluating pulmonary nodules, yet may miss lesions less than 1 cm in size. Lung biopsy is the criterion standard for diagnosing pulmonary nodules but is an invasive procedure.

Advances in technology have led to enhancements that may increase the yield of established diagnostic methods. CT scanning equipment can be used to guide bronchoscopy and bronchoscopic transbronchial needle biopsy, but have the disadvantage of exposing the patient and staff to radiation. Endobronchial ultrasound (EBUS) by radial probes, previously used in the perioperative staging of lung cancer, can also be used to locate and guide sampling of peripheral lesions. EBUS is reported to increase the diagnostic yield of flexible bronchoscopy to at least 82%, regardless of the size and location of the lesion.

Marker Placement

Another proposed enhancement to standard bronchoscopy is electromagnetic navigation bronchoscopy (ENB). ENB is intended to enhance standard bronchoscopy by providing a 3-dimensional roadmap of the lungs and real-time information about the position of the steerable probe during bronchoscopy. The purpose of ENB is to allow navigation to distal regions of the lungs. Once the navigation catheter is in place, any endoscopic tool can be inserted through the channel in the catheter to the target. This includes insertion of transbronchial forceps to biopsy the lesion. In addition, the guide catheter can be used to place fiducial markers. Markers are loaded in the proximal end of the catheter with a guide wire inserted through the catheter.

KEY POINTS:

This review has been updated regularly with searches of the MEDLINE database. Most recently, the literature was reviewed through April 21, 2022.

Summary of Evidence

For individuals who have suspicious peripheral pulmonary lesion(s) when flexible bronchoscopy alone or with endobronchial ultrasound are inadequate to sample the pulmonary lesion(s), the evidence includes meta-analyses, a randomized controlled trial (RCT), and uncontrolled prospective observational studies. Relevant outcomes are test accuracy and validity, other test performance measures, and treatment-related morbidity. A 2020 meta-analysis of 40 studies and a 2015 meta-analysis of 17 studies of ENB reported a large pooled positive likelihood ratio but a small negative likelihood ratio (0.2 to 0.22 ). Similarly, a 2014 meta-analysis of 15 studies found that navigation success was high, but diagnostic yield (64.9; 95% confidence interval [CI], 59.2 to 70.3) and negative predictive value (52.1; 95% CI, 43.5 to 60.6) were relatively low. The systematic reviews assessed the methodological quality of the evidence as low. Results from 2 large prospective multicenter uncontrolled studies, AQuiRE (American College of Chest Physicians Quality Improvement Registry, Evaluation, and Education) and NAVIGATE (Clinical Evaluation of superDimension Navigation System for Electromagnetic Navigation Bronchoscopy), provide information about test characteristics and safety of ENB. An analysis of more than 500 patients included in the AQuiRE registry found a diagnostic yield of ENB that was lower than in other studies, and lower than bronchoscopy without ENB or endobronchial ultrasound. In the US cohort of the NAVIGATE study, the 2-year diagnostic yield was 69.8%. Overall, 4.3% of patients experienced pneumothorax, and grade 2 or higher pneumothorax occurred in 2.9% of patients. Overall, bronchopulmonary hemorrhage occurred in 2.5% of patients, and grade 2 or higher bronchopulmonary hemorrhage in 1.6% of patients. There were no deaths related to the ENB device. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have enlarged mediastinal lymph nodes who receive ENB with flexible bronchoscopy, the evidence includes a RCT and case series. Relevant outcomes are test accuracy and validity, other test performance measures, and treatment-related morbidity. There is less published literature on ENB for diagnosing mediastinal lymph nodes than for diagnosing pulmonary lesions. One RCT identified found higher sampling and diagnostic success with ENB-guided transbronchial needle aspiration than with conventional transbronchial needle aspiration. Endobronchial ultrasound, which has been shown to be superior to conventional transbronchial needle aspiration, was not used as the comparator. The RCT  did not report the diagnostic accuracy of ENB for identifying malignancy, and this was also not reported in uncontrolled studies. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lung tumor(s) who need fiducial marker placement prior to treatment when flexible bronchoscopy alone or with endobronchial ultrasound are inadequate to place the markers near the pulmonary lesion(s), the evidence includes 1 comparative observational study and several noncomparative observational studies and case series. Relevant outcomes are health status measures and treatment-related morbidity. In the largest series, a subgroup analysis of 258 patients from the NAVIGATE study, the subjective assessment of outcome was that 99.2% of markers were accurately placed and 94.1% were retained at follow-up (mean 8.1 days postprocedure). Pneumothorax of any grade occurred in 5.4% of patients, and grade 2 or higher pneumothorax occurred in 3.1%. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network

Current National Comprehensive Cancer Network (v.3.2022) practice guidelines on non-small-cell lung cancer state that the strategy for diagnosing lung cancer should be individualized and the least invasive biopsy with the highest diagnostic yield is preferred as the initial diagnostic study.  

  • "Patients with central masses and suspected endobronchial involvement should undergo bronchoscopy.
  • Patients with peripheral (outer one-third) nodules may benefit from navigational bronchoscopy, radial EBUS [endobronchial ultrasound], or transthoracic needle aspiration...
  • Patients with suspected nodal disease should be biopsied by EBUS, EUS [endoscopic ultrasound], navigation biopsy, or mediastinoscopy."

American College of Chest Physicians (ACCP)

In 2013, the American College of Chest Physicians (ACCP) issued updated guidelines on the diagnosis of lung cancer.  Regarding ENB, the guideline stated: “In patients with peripheral lung lesions difficult to reach with conventional bronchoscopy, electromagnetic navigation guidance is recommended if the equipment and the expertise are available.” The authors noted that the procedure can be performed with or without fluoroscopic guidance and has been found to complement radial probe ultrasound. The strength of evidence for this recommendation as Grade 1C, defined as “Strong recommendation, low- or very-low-quality evidence.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Bronchoscopy, electromagnetic navigation, InReach, SuperDimension, ENB, Veran, IG4, SPiN Drive

APPROVED BY GOVERNING BODIES:

In September 2004, the SuperDimension/Bronchus (superDimension Ltd, Herzliya, Israel) was cleared for marketing by the FDA through the 510(k) process. The system includes planning and navigation software, a disposable extended working channel and a disposable steerable guide. The FDA-cleared indication is for displaying images of the tracheobronchial tree that aids physicians in guiding endoscopic tools in the pulmonary tract. The device is not intended as an endoscopic tool, does not make a diagnosis and is not approved for pediatric use.

In December 2009, the ig4™ EndoBronchial system (Veran Medical; St. Louis, MO) was cleared for marketing by the FDA through the 510(k) process. The system was considered to be substantially equivalent to the InReach system and is marketed as the SPiN™ Drive system.

Several additional navigation software-only systems have been cleared for marketing by the FDA through the 510(k) process. These include:

  • December 2008: The LungPoint® virtual bronchoscopic navigation (VPN) system (Broncus Technologies, Mountain View, CA).
  • June 2010: The bf-NAVI virtual bronchoscopic navigation (VPN) system (Emergo Group, Austin, TX)

Two ENB systems are currently available, the SPiN Thoracic Navigation System™ (Veran Medical Technologies) and the superDimension™ navigation system. [medtronic]

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.

CURRENT CODING:

CPT Codes:

31627

Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with computer-assisted, image-guided navigation (List separately in addition to code for primary procedure)

                      

REFERENCES:

  1. Added value of InReach software on performance characteristics of standard bronchoscopy (NCT00817167). Sponsored by superDimension, Ltd. www.clinicaltrials.gov.
  2. Balbo PE, Bodini BD, Patrucco F et al. Electromagnetic navigation bronchoscopy and rapid on site evaluation added to fluoroscopy-guided assisted bronchoscopy and rapid on site evaluation: improved yield in pulmonary nodules. Minerva Chir 2013; 68(6):579-585.
  3. Bechara R, Parks C, Ernst A. Electromagnetic navigation bronchoscopy. Future Oncol 2011; 7(1):31-36.
  4. Bolton WD, Richey J, Ben-Or S, et al. Electromagnetic navigational bronchoscopy: a safe and effective method for fiducial marker placement in lung cancer patients. Am Surg. Jul 2015; 81(7):659-662.
  5. Bowling MR, Folch EE, Khandhar SJ, et al. Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study. Ther Adv Respir Dis. Jan-Dec 2019; 13: 1753466619841234.
  6. Bowling, MM, Folch, EE, Khandhar, SS, Kazakov, JJ, Krimsky, WW, LeMense, GG, Linden, PP, Murillo, BB, Nead, MM, Pritchett, MM, Teba, CC, Towe, CC, Williams, TT, Anciano, CC. Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study.. Ther Adv Respir Dis, 2019 Apr 9;13:1753466619841234.
  7. Brownback KR, Quijano F, Latham HE et al. Electromagnetic navigational bronchoscopy in the diagnosis of lung lesions. J Bronchology Interv Pulmonol 2012; 19(2):91-97.
  8. Chee A, Stather DR, Maceachern P et al. Diagnostic utility of peripheral endobronchial ultrasound with electromagnetic navigation bronchoscopy in peripheral lung nodules. Respirology 2013; 18(5):784-789.
  9. Detterbeck FC, Mazzone PJ, Naidich DP, et al. Screening for lung cancer: Diagnosis and management of lung cancer, 3rd ed:American College of Chest Physicians evidence-based clinical practice guidelines. Chest. May 2013; 143(5 Suppl): e78S-e92S.
  10. Diken OE, Karnak D, Ciledag A, et al. Electromagnetic navigation-guided TBNA vs conventional TBNA in the diagnosis of mediastinal lymphadenopathy. Clin Respir J. Apr 2015; 9(2):214-220.
  11. Du Rand IA, Barber PV, Goldring J et al. British Thoracic Society guideline for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax 2011; 66 Suppl 3:iii1-21.
  12. Folch EE, Bowling MR, Pritchett MA, et al. NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States. J Thorac Oncol. Apr 2022; 17(4): 519-531.
  13. Folch EE, Labarca G, Ospina-Delgado D, et al. Sensitivity and Safety of Electromagnetic Navigation Bronchoscopy for Lung Cancer Diagnosis: Systematic Review and Meta-analysis. Chest. Oct 2020; 158(4): 1753-1769.
  14. Folch EE, Pritchett MA, Nead MA, et al. Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study. J Thorac Oncol. Mar 2019; 14(3): 445-458.
  15. Folch, EE, Pritchett, MM, et al. Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study.. J Thorac Oncol, 2018 Nov 27;14(3).
  16. Gex G, Pralong JA, Combescure C, et al. Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. Respiration. 2014; 87(2):165-176.
  17. Gildea TR, Mazzone PJ, Karnak D, et al. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med 2006; 174(9):982-989.
  18. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  19. Jensen KW, Hsia DW, Seijo LM et al. Multicenter experience with electromagnetic navigation bronchoscopy for the diagnosis of pulmonary nodules. J Bronchology Interv Pulmonol 2012; 19(3):195-199.
  20. Key Statistics for Lung Cancer. American Cancer Society. https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Updated February 14, 2022. Accessed April 26, 2022.
  21. Khandhar SJ, Bowling MR, Flandes J, et al. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med. Apr 11 2017; 17(1):59.
  22. Lamprecht B, Porsch P, Wegleitner B et al. Electromagnetic navigation bronchoscopy (ENB): Increasing diagnostic yield. Respir Med 2012; 106(5):710-715.
  23. Minnich DJ, Bryant AS, Wei B, et al. Retention rate of electromagnetic navigation bronchoscopic placed fiducial markers for lung radiosurgery. Ann Thorac Surg. Oct 2015; 100(4):1163-1165; discussion 1165-1166.
  24. Nabavizadeh N, Zhang J, Elliott DA, et al. Electromagnetic navigational bronchoscopy-guided fiducial markers for lung stereotactic body radiation therapy: analysis of safety, feasibility, and interfraction stability. J Bronchology Interv Pulmonol. Apr 2014; 21(2):123-130.
  25. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer. Version 6.2017. 2017; //www.nccn.org/professionals/physician_gls/pdf/nscl.pdf.
  26. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer.Version 5.2020. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed May 28, 2020.
  27. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer. Version 4.2021. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed May 6, 2021.
  28. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer. Version 3.2022. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed April 21, 2022.
  29. National Comprehensive Cancer Network (NCCN). Non-small cell lung cancer Version 4, 2016. //www.nccn.org/professionals/physician_gls/pdf/nscl.pdf
  30. National Comprehensive Cancer Network (NCCN). Non-small cell lung cancer Version 2, 2014. 2014. //www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. 3.
  31. Ost DE, Ernst A, Lei X, et al. Diagnostic yield and complications of bronchoscopy for peripheral lung lesions. Results of the AQuIRE registry. Am J Respir Crit Care Med. Jan 1 2016; 193(1):68-77.
  32. Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. May 2013; 143(5 Suppl):e142S-65S.
  33. Rong Y, Bazan JG, Sekhon A, et al. Minimal inter-fractional fiducial migration during image-guided lung stereotactic body radiotherapy using superlock nitinol coil fiducial markers. PLoS One. 2015; 10(7):e0131945.
  34. Steinfort DP, Bonney A, See K, et al. Sequential multimodality bronchoscopic investigation of peripheral pulmonary lesions. Eur Respir J. Feb 2016; 47(2):607-614.
  35. Surveillance, Epidemiology, and End Results Program (SEER). National Cancer Institute. https://seer.cancer.gov/statistics-network/ Accessed April 26, 2022.
  36. Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest 2012; 142(2):385-393.
  37. Wiener RS, Wiener DC, Gould MK. Risks of transthoracic needle biopsy: how high? Clin Pulm Med. Jan 01 2013; 20(1):29-35.
  38. Zhang W, Chen S, Dong X, et al. Meta-analysis of the diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules. J Thorac Dis. May 2015; 7(5):799-809.

POLICY HISTORY:

Medical Policy Group, December 2009 (3)

Medical Policy Group, January 2010 (3)

Medical Policy Administration Committee, January 2010

Available for comment January 26-February 22, 2010

Medical Policy Group, February 2010 (3)

Medical Policy Administration Committee, February 2010

Available for comment February 23-April 8, 2010

Medical Policy Group, March 2011

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

Medical Policy Panel, January 2013.

Medical Policy Group, January 2013 (3):  Updated Description, Key Points & References. Policy statement remains unchanged.

Medical Policy Panel, January 2014

Medical Policy Group, January 2014 (3):  Update to Key Points & References; no change in policy statement

Medical Policy Group, May 2014 (3): Removed Code 31626 from Coding Section placed there in error.

Medical Policy Group, June 2014 (3): Updated policy with link to CareCore National© medical policies effective August 1, 2014

Medical Policy Administration Committee, June 2014

Available for comment June 16 through July 31, 2014

Medical Policy Group, July 2014: Removed CareCore link. Transfer to CareCore is on hold until further notice. The policy has been returned to FINAL.

Medical Policy Panel, January 2015

Medical Policy Group, January 2015 (2): 2015 Updates to Key Points and References, no change to policy statement.

Medical Policy Panel, June 2016

Medical Policy Group, June 2016 (7): 2016 Updates to Key Points and References, no change to policy statement.

Medical Policy Panel, July 2017

Medical Policy Group, July 2017 (7): Updates to Key Points and References, no change to policy statement.

Medical Policy Panel, June 2018

Medical Policy Group, June 2018 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (5): Updates to Description, Key Points, References, and Policy Statement- Opened up coverage for individuals with either suspicious peripheral pulmonary lesion(s) or with lung tumor(s) who need fiducial marker placement prior to treatment when flexible bronchoscopy alone or with endobronchial ultrasound are considered inadequate to accomplish the procedure.

Medical Policy Administrative Committee, August 2019.

Available for comment August 1, 2019 through September 15, 2019.

Medical Policy Panel, July 2020

Medical Policy Group, July 2020 (5): Updates to Policy Statement verbiage for clarification, Key Points, Practice Guidelines and Position Statements, and References. No change in policy intent.

Medical Policy Panel, June 2021

Medical Policy Group, July 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and Refereences. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, June 2022

Medical Policy Group, June 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. 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.