Electromagnetic Navigation Bronchoscopy (ENB) (L30510)
Contractor Information
|
Contractor Name Wisconsin Physicians Service Insurance Corporation |
Contractor Number 00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402 |
Contractor Type Carrier - FI - MAC |
LCD Information
Document Information
L30510 LCD Title Electromagnetic Navigation Bronchoscopy (ENB) Contractor's Determination Number PULM-007 AMA CPT/ADA CDT Copyright Statement CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply. |
Primary Geographic Jurisdiction
Oversight Region Original Determination Effective Date For services performed on or after 02/15/2010 Original Determination Ending Date Revision Effective Date For services performed on or after 10/01/2011 Revision Ending Date |
CMS National Coverage Policy
Indications and Limitations of Coverage and/or Medical Necessity
Indications:
Despite spectacular medical advances in the last 50 years, lung cancer causes more deaths than any other cancer in both men and women. It is now the most common form of cancer diagnosed in the United States and a major cause of death, accounting for 14% of all cancers and 31% all cancer deaths in males.
Electromagnetic navigation bronchoscopy systems are designed to biopsy peripheral lung lesions by an endobronchial route using a real-time navigation system. The navigation system tracks positioning of the bronchoscope tip on a three-dimensional (3- D) map of the inner lung constructed from a recent computed tomography (CT) lung scan. The navigation system is inserted into the working channel of a bronchoscope and uses CT scanning and low frequency electromagnetic field guiding technology along with a standard steerable fiber optic camera to re-create the 3-D mapping onto previously defined anatomical landmarks. When peripheral foci are reached, an extended working channel is locked in position through which tissues samples are biopsied.
The ENB system consists of four essential components:
1. Computer software that creates a three-dimensional (3D), virtual bronchoscopy reconstruction from CT images;
2. An electromagnetic location board which emits a low-dose electromagnetic field;
3. A steerable sensor probe that is locatable within the electromagnetic field, and
4. An extended working channel (EWC) that when secured enables the placement of the bronchoscopic tools to the lung periphery.
The digitized information from the patient's CT scan is imported into the electromagnetic navigation system where axial, coronal and sagittal views of the chest and virtual endoscopy images are reconstructed. Anatomic landmarks are identified as coordinates on the corresponding CT as well as on the virtual bronchoscopy image (planning). The same identifiable landmarks are then used during real-time bronchoscopy in order to relate the CT data to the actual anatomy. When these points were touched with the sensor, they were simultaneously recorded by the navigation system (registration). After registration, navigation is performed with simultaneous advancement of the steerable probe toward the target and directing the steerable probe to the lesion.
The ENB system enables real-time navigation guidance within the lungs to endobronchially invisible targets and subsequent biopsy through the extending working channel. This procedure can also be used for the bronchoscopic placement of fiducial markers with ENB guidance. These markers can facilitate treatment localization for stereotactic radiosurgery in patients with early-stage bronchogenic carcinoma who are otherwise unfit for surgical resection.
Electromagnetic Navigation for Bronchoscopy will be considered medically necessary for the following conditions:
Solitary Pulmonary Nodule:
Patients identified with Solitary Pulmonary Nodules in which malignancy is reasonably suspected and it has been determined that a tissue diagnosis is required, and
- the lesion is poorly accessible by standard bronchoscopy, or
- a more invasive procedure for diagnosis and/or staging pose a significant risk, i.e. high pneumothorax risk, bullous lung disease, diffuse emphysema, etc.
Lung Lesion with a Coexisting Cancer:
Patients with an identified lung lesion(s) and a coexisting cancer in whom further determination of the lung lesion may impact the staging of the primary malignancy, and thus the treatment.
Placement of Fiducial markers:
- Fiducial marker placement will be considered medically necessary when a brushing, washing, aspirate or biopsy shows a malignancy or high suspicion of a malignancy and the patients is considered a candidate for stereotactic radiosurgery.
Limitations:
Electromagnetic Navigation for Bronchoscopy is not considered medically reasonable and necessary when:
- The patient has a solitary pulmonary nodule that is stable on imaging tests for at least two years,
- The patient has a solitary pulmonary nodule that is calcified in a clearly benign pattern,
- The patient has a low pretest probability of malignancy (<30 to 40%) and an indeterminant solitary pulmonary nodule that measures at least 8 to 10 mm in diameter, and the lesion is not hypermetabolic by FDG-PET imaging, or does not enhance .15 HU on dynamic contrast CT.
- CT scan indicates the lesion is accessible by a standard flexible bronchoscopy.
The diagnostic yield of ENB may be affected by CT-to-body divergence rather than the size or location of the lesion. The ENB yield was found to be significantly lower when CT-to-body divergence was 10 mm.
Despite spectacular medical advances in the last 50 years, lung cancer causes more deaths than any other cancer in both men and women. It is now the most common form of cancer diagnosed in the United States and a major cause of death, accounting for 14% of all cancers and 31% all cancer deaths in males.
Electromagnetic navigation bronchoscopy systems are designed to biopsy peripheral lung lesions by an endobronchial route using a real-time navigation system. The navigation system tracks positioning of the bronchoscope tip on a three-dimensional (3- D) map of the inner lung constructed from a recent computed tomography (CT) lung scan. The navigation system is inserted into the working channel of a bronchoscope and uses CT scanning and low frequency electromagnetic field guiding technology along with a standard steerable fiber optic camera to re-create the 3-D mapping onto previously defined anatomical landmarks. When peripheral foci are reached, an extended working channel is locked in position through which tissues samples are biopsied.
The ENB system consists of four essential components:
1. Computer software that creates a three-dimensional (3D), virtual bronchoscopy reconstruction from CT images;
2. An electromagnetic location board which emits a low-dose electromagnetic field;
3. A steerable sensor probe that is locatable within the electromagnetic field, and
4. An extended working channel (EWC) that when secured enables the placement of the bronchoscopic tools to the lung periphery.
The digitized information from the patient's CT scan is imported into the electromagnetic navigation system where axial, coronal and sagittal views of the chest and virtual endoscopy images are reconstructed. Anatomic landmarks are identified as coordinates on the corresponding CT as well as on the virtual bronchoscopy image (planning). The same identifiable landmarks are then used during real-time bronchoscopy in order to relate the CT data to the actual anatomy. When these points were touched with the sensor, they were simultaneously recorded by the navigation system (registration). After registration, navigation is performed with simultaneous advancement of the steerable probe toward the target and directing the steerable probe to the lesion.
The ENB system enables real-time navigation guidance within the lungs to endobronchially invisible targets and subsequent biopsy through the extending working channel. This procedure can also be used for the bronchoscopic placement of fiducial markers with ENB guidance. These markers can facilitate treatment localization for stereotactic radiosurgery in patients with early-stage bronchogenic carcinoma who are otherwise unfit for surgical resection.
Electromagnetic Navigation for Bronchoscopy will be considered medically necessary for the following conditions:
Solitary Pulmonary Nodule:
Patients identified with Solitary Pulmonary Nodules in which malignancy is reasonably suspected and it has been determined that a tissue diagnosis is required, and
- the lesion is poorly accessible by standard bronchoscopy, or
- a more invasive procedure for diagnosis and/or staging pose a significant risk, i.e. high pneumothorax risk, bullous lung disease, diffuse emphysema, etc.
Lung Lesion with a Coexisting Cancer:
Patients with an identified lung lesion(s) and a coexisting cancer in whom further determination of the lung lesion may impact the staging of the primary malignancy, and thus the treatment.
Placement of Fiducial markers:
- Fiducial marker placement will be considered medically necessary when a brushing, washing, aspirate or biopsy shows a malignancy or high suspicion of a malignancy and the patients is considered a candidate for stereotactic radiosurgery.
Limitations:
Electromagnetic Navigation for Bronchoscopy is not considered medically reasonable and necessary when:
- The patient has a solitary pulmonary nodule that is stable on imaging tests for at least two years,
- The patient has a solitary pulmonary nodule that is calcified in a clearly benign pattern,
- The patient has a low pretest probability of malignancy (<30 to 40%) and an indeterminant solitary pulmonary nodule that measures at least 8 to 10 mm in diameter, and the lesion is not hypermetabolic by FDG-PET imaging, or does not enhance .15 HU on dynamic contrast CT.
- CT scan indicates the lesion is accessible by a standard flexible bronchoscopy.
The diagnostic yield of ENB may be affected by CT-to-body divergence rather than the size or location of the lesion. The ENB yield was found to be significantly lower when CT-to-body divergence was 10 mm.
Coding Information
Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
| 011x | Hospital Inpatient (Including Medicare Part A) |
| 013x | Hospital Outpatient |
| 085x | Critical Access Hospital |
Revenue Codes:
Revenue codes 096X, 097X and 098X are to be used only by Critical Access Hospitals (CAHs) choosing the optional payment method (also called Option 2 or Method 2) and only for services performed by physicians or practitioners who have reassigned their billing rights. When a CAH has selected the optional payment method, physicians or other practitioners providing professional services at the CAH may elect to bill their carrier or Part B MAC, or assign their billing rights to the CAH. When professional services are reassigned to the CAH, the CAH must bill the FI, or Part A MAC using revenue codes 096X, 097X or 098X.
CPT/HCPCS Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.Revenue codes 096X, 097X and 098X are to be used only by Critical Access Hospitals (CAHs) choosing the optional payment method (also called Option 2 or Method 2) and only for services performed by physicians or practitioners who have reassigned their billing rights. When a CAH has selected the optional payment method, physicians or other practitioners providing professional services at the CAH may elect to bill their carrier or Part B MAC, or assign their billing rights to the CAH. When professional services are reassigned to the CAH, the CAH must bill the FI, or Part A MAC using revenue codes 096X, 097X or 098X.
| 0360 | Operating Room Services - General Classification |
| 0361 | Operating Room Services - Minor Surgery |
| 0490 | Ambulatory Surgical Care - General Classification |
| 0960 | Professional Fees - General Classification |
| 0981 | Professional Fees - Emergency Room Services |
| 0982 | Professional Fees - Outpatient Services |
| 0983 | Professional Fees - Clinic |
| 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[S]) |
ICD-9 Codes that Support Medical Necessity
| 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 AND LUNG UNSPECIFIED |
| 197.0 | SECONDARY MALIGNANT NEOPLASM OF LUNG |
| 212.3 | BENIGN NEOPLASM OF BRONCHUS AND LUNG |
| 518.89 | OTHER DISEASES OF LUNG NOT ELSEWHERE CLASSIFIED |
| 793.11 | SOLITARY PULMONARY NODULE |
Diagnoses that Support Medical Necessity
Not applicable
ICD-9 Codes that DO NOT Support Medical Necessity
Not applicable
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
Not applicable
General Information
The patient's
medical record must contain documentation that fully supports the
medical necessity for services outlined in the Indications and
Limitations section of Coverage in this LCD. This documentation
includes, but is not limited to, relevant medical history, physical
examination, and results of pertinent diagnostic tests or procedures
including past radiologic examinations. The medical record must also
contain evidence that diagnostic and treatment alternatives have been
discussed with the patient.
Results of all testing should be shared with the referring physician. Documentation must be available to Medicare upon request.
Appendices
Results of all testing should be shared with the referring physician. Documentation must be available to Medicare upon request.
Electromagnetic
Navigation for Bronchoscopy may be necessary for diagnosis and possible
placement of fiducial markers in those patients with a confirmed or
suspected malignancy. The procedure will be covered only twice per
patient per episode of care. Services exceeding this parameter will be
considered not medically necessary.
*- An asterisk indicates a revision to that section of the policy.
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.
Sources of Information and Basis for Decision
*- An asterisk indicates a revision to that section of the policy.
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.
Anantham, D, et al.
Electromagnetic navigation bronchoscopy guided fiducial placement for
robotic stereotactic radiosurgery of lung tumors - a feasibility study.
Chest 2007;132: 930-935.
NGS Medical Policy Electromagnetic Navigational Bronchoscopy
Becker HD, Herth F, Ernst A, Schwarz Y; Bronchoscopic biopsy of peripheral lung lesions under electromagnetic guidance. J Bronchol. 2005; 12(1):9-13.
Eberhardt R, Anantham D, Ernst A, Feller-Kopman D, Herth F. Multimodality bronchoscopic diagnosis of peripheral lung lesions: A randomized controlled trial. Am J Respir Crit Care Med; 176:36-41.
Eberhardt R, Anantham D, Herth F, Feller-Kopman D, Ernst A. Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest. 2007:1800-1805.
Gildea, TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: A prospective study. Am J Respir Crit Care Med;174:982-989.
Gould, MK, et al. Evaluation of patients with pulmonary nodules: When is it cancer? ACCP evidence-based clinical practice guidelines (2nd Edition).Chest. 2007; 132:108-130
Greenlee RT, et al. Cancer statistics 2000. CA Cancer J Clin. 2000; 50:7-33
Harms W, Krempien R, Grehn C, Hensley F, Debus J, Becker, HD. Strahlenther Onkol. 2006;182:108-111.
Kupelian PA, et al. Implantation and stability of metallic fiducials within pulmonary lesions. Int J Radiation Oncology Biol Phys. 2007; 69(3):777-785.
Makris D, et al. Electromagnetic navigation diagnostic bronchoscopy for small peripheral lung lesions. Eur Respir J. 2007; 29: 1187-1192.
McLemore L, Ochran G, Kerley Endobronchial ultrasound and/or super dimension bronchoscopic placement of fiducial markers in malignant mediastinal lymph nodes (LN) and lung cancers (LC): A novel approach for highly selective external beam radiation therapy (RT). 14th World Congress for Bronchology;2006:57-62.
Schwarz Y, et al. Electromagnetic navigation during flexible bronchoscopy. Interventional Pulmonology. 2003:516-522.
Schwarz Y, Greif J, Becker, HD, Ernst A, Mehta A. real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: The first human study. Chest. 2006; 129:988-994.
Shulman L, Ost D. Advances in bronchoscopic diagnosis of lung cancer. Curr Opin Pulm Med; 13:271-277.
Weiser TS, Hyman K, Yun J, Litle V, Chin C, Swanson, SJ. Electromagnetic navigational bronchoscopy: A surgeon's perspective. Ann Thorac Surg. 2008; 85:S797-801.
Wilson D. Improved diagnostic yield of bronchoscopy in a community based hospital: Combination of electromagnetic navigation system and rapid on-site evaluation. J Bronchol. 2007; 14(4);227-232.
Advisory Committee Meeting Notes
NGS Medical Policy Electromagnetic Navigational Bronchoscopy
Becker HD, Herth F, Ernst A, Schwarz Y; Bronchoscopic biopsy of peripheral lung lesions under electromagnetic guidance. J Bronchol. 2005; 12(1):9-13.
Eberhardt R, Anantham D, Ernst A, Feller-Kopman D, Herth F. Multimodality bronchoscopic diagnosis of peripheral lung lesions: A randomized controlled trial. Am J Respir Crit Care Med; 176:36-41.
Eberhardt R, Anantham D, Herth F, Feller-Kopman D, Ernst A. Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest. 2007:1800-1805.
Gildea, TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: A prospective study. Am J Respir Crit Care Med;174:982-989.
Gould, MK, et al. Evaluation of patients with pulmonary nodules: When is it cancer? ACCP evidence-based clinical practice guidelines (2nd Edition).Chest. 2007; 132:108-130
Greenlee RT, et al. Cancer statistics 2000. CA Cancer J Clin. 2000; 50:7-33
Harms W, Krempien R, Grehn C, Hensley F, Debus J, Becker, HD. Strahlenther Onkol. 2006;182:108-111.
Kupelian PA, et al. Implantation and stability of metallic fiducials within pulmonary lesions. Int J Radiation Oncology Biol Phys. 2007; 69(3):777-785.
Makris D, et al. Electromagnetic navigation diagnostic bronchoscopy for small peripheral lung lesions. Eur Respir J. 2007; 29: 1187-1192.
McLemore L, Ochran G, Kerley Endobronchial ultrasound and/or super dimension bronchoscopic placement of fiducial markers in malignant mediastinal lymph nodes (LN) and lung cancers (LC): A novel approach for highly selective external beam radiation therapy (RT). 14th World Congress for Bronchology;2006:57-62.
Schwarz Y, et al. Electromagnetic navigation during flexible bronchoscopy. Interventional Pulmonology. 2003:516-522.
Schwarz Y, Greif J, Becker, HD, Ernst A, Mehta A. real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: The first human study. Chest. 2006; 129:988-994.
Shulman L, Ost D. Advances in bronchoscopic diagnosis of lung cancer. Curr Opin Pulm Med; 13:271-277.
Weiser TS, Hyman K, Yun J, Litle V, Chin C, Swanson, SJ. Electromagnetic navigational bronchoscopy: A surgeon's perspective. Ann Thorac Surg. 2008; 85:S797-801.
Wilson D. Improved diagnostic yield of bronchoscopy in a community based hospital: Combination of electromagnetic navigation system and rapid on-site evaluation. J Bronchol. 2007; 14(4);227-232.
Advisory Committee Meeting Notes
Meeting Date:
Wisconsin 9/25/09
Illinois 9/16/09
Michigan 9/09/09
Minnesota 09/24/09
J5 MAC 10/08/09
Open LCD meeting:
08/19/09
Start Date of Comment Period
Meeting Date:
Wisconsin 9/25/09
Illinois 9/16/09
Michigan 9/09/09
Minnesota 09/24/09
J5 MAC 10/08/09
Open LCD meeting:
08/19/09
10/08/2009
End Date of Comment Period
11/23/2009
Start Date of Notice Period
01/01/2010
Revision History Number
X
Revision History Explanation
04/19/2010 - In
accordance with Section 911 of the Medicare Modernization Act of 2003,
the states of American Somoa, California, Guam, Hawaii, Nevada and
Northern Mariana Islands were removed from this LCD because claims
processing for those states are transitioning from FI
Contractor Wisconsin Physician Services (WPS - 52280) to MAC Part
A Contractor Palmetto.
8/1/2010 - The description for Bill Type Code 11 was changed
8/1/2010 - The description for Bill Type Code 13 was changed
8/1/2010 - The description for Bill Type Code 85 was changed
8/1/2010 - The description for Revenue code 0360 was changed
8/1/2010 - The description for Revenue code 0361 was changed
8/1/2010 - The description for Revenue code 0490 was changed
8/1/2010 - The description for Revenue code 0960 was changed
8/1/2010 - The description for Revenue code 0981 was changed
8/1/2010 - The description for Revenue code 0982 was changed
8/1/2010 - The description for Revenue code 0983 was changed
10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for those states are transitioning from FI Wisconsin Physicians Service (52280) to MAC Part A Trailblazer (04901).
01/14/2011 Annual review no change in coverage.
02/21/2011 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).
08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.
10/01/2011-2012 ICD-9 Code update article published-Added 793.11 & Annual review no change in coverage
Reason for Change
8/1/2010 - The description for Bill Type Code 11 was changed
8/1/2010 - The description for Bill Type Code 13 was changed
8/1/2010 - The description for Bill Type Code 85 was changed
8/1/2010 - The description for Revenue code 0360 was changed
8/1/2010 - The description for Revenue code 0361 was changed
8/1/2010 - The description for Revenue code 0490 was changed
8/1/2010 - The description for Revenue code 0960 was changed
8/1/2010 - The description for Revenue code 0981 was changed
8/1/2010 - The description for Revenue code 0982 was changed
8/1/2010 - The description for Revenue code 0983 was changed
10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for those states are transitioning from FI Wisconsin Physicians Service (52280) to MAC Part A Trailblazer (04901).
01/14/2011 Annual review no change in coverage.
02/21/2011 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).
08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.
10/01/2011-2012 ICD-9 Code update article published-Added 793.11 & Annual review no change in coverage
This LCD has no Related Documents.
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Page Last Updated: Thursday, 20-Oct-2011 15:47:10 CDT
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