BlueCross and BlueShield of Montana Medical Policy/Codes
Image Guidance Surgery (IGS) System
Chapter: Surgery: Procedures
Current Effective Date: September 24, 2013
Original Effective Date: September 24, 2013
Publish Date: June 24, 2013
Description

IGS systems are designed for use in sinus, spine, cranial, and skull base surgery.  An IGS system combines a high-speed computer system and specialized software and tracking technology. Actual movements of surgical instruments are correlated to the patient’s preoperative medical images such as CT (computed tomography) or MRI (magnetic resonance imaging) and displayed on this computerized system’s display monitor.

IGS systems allow the surgeon to view 3-D images of the patient’s anatomy in response to the mouse or the tracked surgical instrument and manipulate the 3-D view in real time during the surgery.   It is intended as an adjunct to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures.  It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MRI, or X-ray.

The GE Medical Systems Navigation and Visualization Multiple Dataset Navigation option on the InstaTrak™ system is substantially equivalent to the Image Composer application on the Vectorvision iPlan™, manufactured by BrainLAB, and the StealthStation™ with StealthMerge application manufactured by Medtronic.  Each of these devices also offers the capability to fuse multiple data sets from different imaging modalities.  The GE Medical Systems Multiple Dataset Navigation application with InstaTrak™ has the same intended use and utilizes images from the same modalities as these devices.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Medically Necessary

BCBSMT may consider image-guidance surgery (IGS) systems (i.e., InstaTrak™, Vectorvision iPlan™, Stealthstation™, Stryker Navigation System™), and other like systems medically necessary for:

  • Intracranial procedures (excluding routine shunt procedures),
  • Cervical spinal surgery when screws and/or other hardware are applied to the cervical spine,
  • The following sinus and skull base surgical procedures:
    1. Revision endoscopic sinus surgery,
    2. Frontal, posterior ethmoid, or sphenoid sinus surgery when there is documented loss of or altered anatomic landmarks of development, postoperative, or traumatic origin,
    3. Extensive sino-nasal polyposis when there is documentation of sufficient severity to create a need for the precision localization and navigation assistance,
    4. Disease abutting the skull base, orbit, optic nerve or carotid artery,
    5. Cerebral spinal fluid (CSF) rhinorrhea or conditions where there is a skull base defect,
    6. Benign and malignant sino-nasal neoplasms documented to be of sufficient size or of high-risk location to create a need for the precision localization and navigation assistance. 

Not Medically Necessary

BCBSMT considers IGS for all other sinus or skull base surgical procedures not medically necessary.

Investigational

BCBSMT considers IGS for indications other than those noted above is considered experimental, investigational and unproven.

Rationale

Scientific literature review has demonstrated that IGS systems can assist the surgeon by confirming position within challenging anatomical fields, identifying borders and achieving greater surgical accuracy which in turn improves patient outcomes.  Studies have shown the value of IGS to be that of an important adjunctive tool in selected cases of advanced sinus surgery, intracranial surgeries, and pedicle screw placement in the cervical spine.

Intracranial Applications:

IGS are widely used in intracranial surgery.  The imaging capability creates a 3-D reconstruction of the patient’s skull and brain.  The system provides safer and less invasive access to brain tumors, vascular abnormalities and other intracranial targets.  The greatest application of the IGS system is in anatomic navigation around tumor margins and determining regional anatomy.  The surgeon can navigate precisely to the tumor while avoiding sensible structures.  The depth of the tumor can be mapped, as well as critical structures that might lie on the other side of the resection plane.  Such navigation increases the precision of the procedure, and can increase the speed at which surgery can be performed. 

Sinus and Skull base Applications:

IGS is an important adjunctive tool in selected cases of advanced sinus surgery.  Studies have shown that IGS can assist the endoscopic sinus surgeon to confirm positioning of difficult anatomical fields.  IGS surgery has not been proven as the standard of care for routine endoscopic sinus surgery.

The American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) endorses the use of computer-aided (i.e., image-guided) surgery in selected cases, in order to assist the surgeon in localizing anatomical structures and increasing patient safety (AAO-HNS, 2002).

The AAO-HNS examples of indications in which use of image-guidance sinus surgery may be appropriate include the following:

  • revision sinus surgery,
  • distorted sinus anatomy of developmental, postoperative, disease or traumatic origin,
  • extensive sino-nasal polyposis,
  • pathology involving the frontal, posterior ethmoid, or sphenoid sinuses,
  • CSF rhinorrhea or conditions where a skull base defect exists,
  • benign and malignant sino-nasal neoplasms.

Spinal Applications:

Reports and studies note a benefit from image-guidance spinal surgery.  IGS for spinal surgical procedures is currently widely accepted for intracranial procedures as well.  There are important applications for IGS in the cervical spine.  Typical examples include pedicle screw fixation to treat traumatic injuries (placement of C1-C2 transarticular screws where there is a significant risk of vertebral artery injury if the trajectory of the screws is not carefully planned), and the resection of certain spinal tumors and vascular malformations.  In the case of unilateral or bilateral locked facets, several reports have demonstrated the benefits of traction and closed reduction followed by cervical pedicle screw fixation. 

Placement of pedicle screws in the thoracic and lumbar spine has also been aided by image-guided navigation.  Potential future applications of image-guidance spinal surgery include the ability to register transcutaneously, which could facilitate minimally invasive, percutaneous image-guidance spinal surgery.  Basic anatomical knowledge and skill that surgeons need to perform demanding spinal procedures is not supplanted by IGS.  It does, however, provide an added element of confidence, particularly when position and accuracy are critical.  Like any new technique, incorporation of IGS into a surgeon’s collection requires patience and dedication.  The advantages of image-guidance spinal surgery for appropriately selected cases could be substantial.

Note:  Given the absence of well-designed clinical trials documented in the scientific literature to demonstrate the medical effectiveness of this adjunctive technology, coverage is limited for this add-on code to those applications where there exists clinical data to support its use.

2010 Update

A search of peer reviewed literature through November 2010 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

ICD-9 Codes

Refer to the ICD-9-CM manual.

ICD-10 Codes

Refer to the ICD-10-CM manual.

Procedural Codes: 61781, 61782, 61783
References
  1. U.S. Food and Drug Administration (FDA). Summary of safety and effectiveness. StealthStation System-FluoroNav Module™. 4/22/99.
  2. Uddin, F.J., Sama, A., et al, Three-dimensional computer-aided endoscopic sinus surgery. Journal of Laryngology Otology. (2003 May) 117(5):333-9.
  3. Tabee, A., Kacker, A., et al, Outcome of computer-assisted sinus surgery: a 5-year study, American Journal of Rhinology. (2003 Sep-Oct): 17(5):291-7.
  4. U.S. Food and Drug Administration (FDA), Department of Health and Human Services, 501K Summary, K040050, Insta Trak™ 3500 Plus with Multiple Dataset Navigation, 4/24/2004.
  5. U.S. Food and Drug Administration (FDA). 510(k)s Final decisions rendered for March 2000. Visualization Technology, Inc. InstaTrak 3000 System with Fluorotrak Module. 3/9/2004.
  6. Kingdom, T.T., Orlandi, R.R., Image-guided surgery of the sinuses: current technology and applications. Otolaryngology Clinical North America. (2004 April) 37(2):381-400.
  7. Issada, T., Hoang, L., et al.  Minimally Invasive Spinal Surgery: A Historical Perspective.  Neurosurg Focus. (2004 April 4) 16(1).
  8. Seller, K., Wild, A., et al.  Prospective screw misplacement analysis after conventional and navigated pedicle screw implantation.  Biomed Tech (2005) 50(9):287-92.
  9. American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS). AAO-HNS policy on intra-operative use of computer-aided surgery. Approved (2004 Sept. 12). Accessed Nov 2, 2005. Available at www.entlink.net
  10. Johnson, J. P., King, W.A., et al.  Computer-guided Endoscopic Neurosurgery in the Thoracic Spine.  US Neurosurgical Disease (2006):56-8.
  11. Fried, M, Parikh, S. et al. Image-Guidance for Endoscopic Sinus Surgery The Laryngoscope Volume 118, Issue 7, pages 1287–1292, July 2008.  Accessed December 2010.
History
June 2013  New 2013 BCBSMT medical policy.
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Image Guidance Surgery (IGS) System