Electromagnetic Navigation- Guided Bronchoscopy

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ELECTROMAGNETIC NAVIGATION- GUIDED BRONCHOSCOPY HS-234

Clinical Coverage Guideline page 1 Original Effective Date: 12/5/2013 - Revised: 12/4/2014, 12/3/2015

Easy Choice Health Plan, Inc.

Exactus Pharmacy Solutions, Inc.

Harmony Health Plan of Illinois, Inc.

Missouri Care, Incorporated

WellCare Health Insurance of Arizona, Inc., operating in Hawai‘i as ‘Ohana Health Plan, Inc.

WellCare of Kentucky, Inc.

WellCare Health Plans of Kentucky, Inc.

WellCare Health Plans of New Jersey, Inc.

WellCare of Connecticut, Inc.

WellCare of Florida, Inc., operating in Florida as Staywell

WellCare of Georgia, Inc.

WellCare of Louisiana, Inc.

WellCare of New York, Inc.

WellCare of South Carolina, Inc.

WellCare of Texas, Inc.

WellCare Prescription Insurance, Inc.

Windsor Health Plan, Inc.

Electromagnetic Navigation- Guided Bronchoscopy

Policy Number: HS-234

Original Effective Date: 12/5/2013

Revised Date(s): 12/4/2014; 12/3/2015 APPLICATION STATEMENT

The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

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ELECTROMAGNETIC NAVIGATION- GUIDED BRONCHOSCOPY HS-234

DISCLAIMER

The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: Lines of business (LOB) are subject to change without notice; current LOBs can be found at www.wellcare.com – select the Provider tab, then

“Tools” and “Clinical Guidelines”.

BACKGROUND

ENB (Electromagnetic Navigation Bronchoscopy) or EMN bronchoscopy is a medical procedure utilizing electromagnetic technology designed to localize and guide endoscopic tools or catheters through the bronchial pathways of the lung. Using a virtual, three-dimensional (3D) bronchial map from a recently computed tomography (CT) chest scan and disposable catheter set, physicians are able to navigate to a desired location within the lung to biopsy lesions, stage lymph nodes, insert markers to guide radiotherapy or guide brachytherapy catheters. (Gildea, Mazzone, Karnak, Meziane, & Mehta, 2006). Electromagnetic Navigation Bronchoscopy consists of two primary phases: planning and navigation. In the planning phase previously acquired CT scans are utilized to mark and plan pathways to targets within the lung. In the navigation phase these previously planned targets and pathways are displayed and can be utilized for navigation and access deep within the lung. Upon arriving at the target ENB enables multiple applications all within the same procedure. (Heinrich, & Becker, 2005).

Professional Statements

The American College of Chest Physicians (ACCP) (2007) stated that newer modalities such as ultrathin

bronchoscopy, CT fluoroscopy, multiplanar volume reformation, and electromagnetic navigation are being studied for their impact on the diagnostic yield of fiberoptic bronchoscopy for lung cancer, yet no recommendation can be made based on the preliminary results of the studies (Rivera & Mehta, 2007).

The British Thoracic Society (2011) developed guidelines concerning advanced diagnostic and therapeutic flexible bronchoscopy in adult patients (Du Rand & et al., 2011). Their findings state ENB as one of the more recent diagnostic applications using a flexible bronchoscope however, despite its high safety and efficacy, there is a high cost factor. Further, studies demonstrate that virtual bronchoscopy used alone can reach comparable diagnostic rates as ENB.

POSITION STATEMENT Applicable To:

Medicaid Medicare

The use of electromagnetic navigation-guided bronchoscopy (e.g., superDimension System) for the management of peripheral lung lesions and placement of fiducial markers is considered experimental and investigational due to a lack of evidence of its effectiveness.

CODING

Non-Covered CPT®* Codes

31626 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with placement of fiducial markers, single or multiple

+31627 - with computer-assisted,

image-guided navigation (list separately in addition to code for primary procedure)

76376 3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality with image post processing under concurrent supervision; not requiring image postprocessing on an independent workstation

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ELECTROMAGNETIC NAVIGATION- GUIDED BRONCHOSCOPY HS-234

76377 3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality with image postprocessing under concurrent supervision; not requiring image postprocessing on an independent workstation.

76499 Unlisted diagnostic radiographic procedure Non-Covered ICD-9-CM Diagnosis Codes

162.3 Malignant neoplasm of upper lobe bronchus or lung 162.4 Malignant neoplasm of middle lobe bronchus or lung 162.5 Malignant neoplasm of lower lobe bronchus or lung 162.8 Malignant neoplasm of other parts of bronchus or lung 162.9 Malignant neoplasm of bronchus or lung, unspecified

196.1 Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes 197.0 Secondary malignant neoplasm of lung

212.3 Benign neoplasm of bronchus and lung 518.89 Other diseases of lung not otherwise classified 785.6 Enlargement of lymph nodes

793.11-793.2 Nonspecific (Abnormal) findings on radiological and other examination of lung field Non-Covered Draft ICD-10-CM Diagnosis Codes

C34.10–C34.12 Malignant neoplasm of upper lobe, bronchus or lung C34.2 Malignant neoplasm of middle lobe, bronchus or lung C34.30-C34.32 Malignant neoplasm of lower lobe, bronchus or lung

C34.80-C34.82 Malignant neoplasm of overlapping sites of bronchus and lung C34.90-C34.92 Malignant neoplasm of unspecified part of bronchus or lung

C77.1 Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes C78.00-C78.02 Secondary malignant neoplasm of right lung, left lung, or unspecified lung D14.30-D14.32 Benign neoplasm of right, left, or unspecified bronchus and lung

J98.4 Other disorders of lung

R59.0-R59.9 Localized, Generalized, or enlarged lymph nodes

R91.1-R91.8 Solitary pulmonary nodule,other nonspecific abnormal finding of lung field R93.1 Abnormal findings on diagnostic imaging of heart and coronary circulation R93.8 Abnormal findings on diagnostic imaging of other specified body structures

*Current Procedural Terminology (CPT®) 2015 American Medical Association: Chicago, IL.

REFERENCES

1. Du Rand IA, Barber PV, Goldring J, et al. Summary of the British Thoracic Society guidelines for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax. 2011;66(11), 1014-1015.

2. Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy. American Journal of Respiratory and Critical Care Medicine. 2006;174(9), 982-989.

3. Computed tomography (CT)-guided lung biopsy with the superDimension i-Logic System (Covidien). Hayes Directory Web site.

http://www.hayesinc.com. Published April 24, 2013 [updated March 18, 2015]. Accessed November 11, 2015.

4. Heinrich D, Becker MF. Bronchoscopic biopsy of peripheral lung lesions under electromagnetic guidance. Journal of Bronchology.

2005;12(1), 9-13.

5. Rivera MP, Mehta AC. Initial diagnosis of lung cancer: American College of Chest Physicians evidence-based clinical practice guidelines (2nd edition). Chest. 2007;132(3 Suppl), 131S-148S.

MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS

Date Action

12/3/2015, 12/4/2014  Approved by MPC. Updated coding.

12/5/2013  Approved by MPC. New.