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Date Printed: June 23, 2017: 11:39 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-20000-30

Original Effective Date: 07/15/04

Reviewed: 03/23/17

Revised: 04/15/17

Subject: Computer-Assisted Navigation for Orthopedic Procedures

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Computer-assisted navigation (CAN) in orthopedic procedures describes the use of computer-enabled tracking systems to facilitate alignment in a variety of surgical procedures, including fixation of fractures, ligament reconstruction, osteotomy, tumor resection, preparation of the bone for joint arthroplasty, and verification of the intended implant placement.

CAN devices may be image-based or non-image based. Image-based devices use preoperative computed tomography (CT) scans and operative fluoroscopy to direct implant positioning. Newer non-image based devices use information obtained in the operating room, typically with infrared probes. Fixing signaling transducers with pins into the femur and tibia makes specific anatomic reference points. Signal emitting cameras (e.g., infrared) detect the reflected signals and transmit the data to a dedicated computer. During the surgical procedure multiple surface points are taken from the distal femoral surfaces, tibial plateaus, and medial and lateral epicondyles. The femoral head center is typically calculated by kinematic methods that involve movement of the thigh through a series of circular arcs, with the computer producing a three-dimensional model that includes the mechanical, transepicondylar and tibial rotational axes. CAN systems direct the positioning of the cutting blocks and placement of the prosthetic implants based on the digitized surface points and model of the bones in space. The accuracy of each step of the operation (cutting block placement, saw cut accuracy, seating of the implants) can be verified, thereby allowing adjustments to be made during surgery.

Since CAN is a surgical information system in which the surgeon is only acting on the information that is provided by the navigation system, surgical navigation systems generally are subject only to 510(k) clearance from the U.S. Food and Drug Administration (FDA). As such, the FDA does not require data documenting the intermediate or final health outcomes associated with CAN. (In contrast, robotic procedures, in which the actual surgery is robotically performed, are subject to the more rigorous requirement of the premarket approval application [PMA] process.) A variety of surgical navigation procedures have received FDA clearance through the 510(k) process with broad labeled indications.

POSITION STATEMENT:

Computer-assisted surgery for orthopedic procedures of the pelvis and appendicular skeleton is considered experimental or investigational. The evidence is insufficient to determine the effects of the procedure on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding

20985

Computer-assisted surgical navigational procedure for musculoskeletal procedures; image-less (list separately in addition to code for primary procedure) (investigational)

HCPCS Coding

0054T

Computer-assisted musculoskeletal surgical navigational orthopedic procedure, with image-guidance based on fluoroscopic images (list separately in addition to code for primary procedure) (investigational)

0055T

Computer-assisted musculoskeletal surgical navigational orthopedic procedure, with image-guidance based on CT/MRI images (list separately in addition to code for primary procedure) (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services ((L33777)) located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Computer Assisted Surgical Navigational Procedures and Other Devices, 02-99221-14

OTHER:

None Applicable.

REFERENCES:

  1. Biasca N, Wirth S, Bungartz M, Mechanical Accuracy of Navigated Minimally Invasive Total Knee Arthroplasty (MID TKA), 2009 Jan; 16(1): 22-9.
  2. Blakeney WG, Khan RJ, Palmer JL. Functional outcomes following total knee arthroplasty: a randomised trial comparing computer-assisted surgery with conventional techniques. Knee 2014; 21(2):364-8.
  3. Blue Cross Blue Shield Association Medical Policy Reference Manual 7.01.96 Computer-Assisted Navigation for Orthopedic Procedure, 01/17.
  4. Blue Cross Blue Shield Association 2008 TEC Assessment, Computer-Assisted Navigation for Total Knee Arthroplasty.
  5. ClinicalTrials.gov, Comparison of Navigation and Conventional Total Knee Arthroplasties, sponsored by Chang Gung Memorial Hospital, accessed 02/14/17.
  6. ClinicalTrials.gov, iAssist vs. Conventional Instrumentation in Total Knee Arthroplasty Using the Persona Knee System Among Patients With BMI>=30: Radiographic, Clinical and Economic Outcomes, sponsored by Hadassah Medical Organization, accessed 07/29/14.
  7. ClinicalTrials.gov, Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision, sponsored by Charite University, Berlin, Germany, accessed 07/29/14.
  8. ClinicalTrials.gov, Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System, sponsored by Orthosensor, Inc. Accessed 07/29/14.
  9. ClinicalTrials.gov, Randomised Controlled Double-blind Monocenter Therapy Study Validating the Benefit From Information Provided by Image Free Navigation System on the Precision of the Placement of Acetabular Component in Patients Undergoing Primary THA, sponsored by Aesculap AG, accessed 07/19/13.
  10. Dutton AQ, Yeo SJ, Y KY, et all, Computer-Assisted Minimally Invasive Total Knee Arthroplasty compared with Standard Total Knee Arthroplasty, The Journal of Bone and Joint Surgery. 2009 Mar 1; 91 Suppl 2.
  11. Eggerding V, Reijman M, Scholten RJ, et al. Computer-assisted surgery for knee ligament reconstruction. Cochrane Database Syst Rev. 2014.
  12. First Coast Service Options, Inc, LCD for Noncovered Services ((L33777)), accessed at fcso.com.
  13. Gallie PA, et al, Computer-Assisted Navigation for the Assessment of Fixed Flexion in Knee Arthroplasty, Can J Surg. 2010 February; 53(1): 42-46.
  14. Gothesen O, Espehaug B, Havelin LI et al. Functional outcome and alignment in computer-assisted and conventionally operated total knee replacements: a multicentre parallel-group randomised controlled trial. Bone Joint J 2014; 96-B(5):609-18.
  15. Hayes Inc., Imageless Computer-Assisted Surgical (CAS) Navigation for total Knee Replacement Surgery, 07/07.
  16. Hayes Search & Summary, Imageless Computer-Assisted Surgical Navigation for Orthopedic Indications, 01/18/06.
  17. Jiang L, Chen JY, et al. Clinical outcomes of computer-assisted total knee arthroplasty using pinless navigation, J Orthop Surg, 2017 Jan;25(1):2309499016684319.
  18. Kim YH, et al, Computer-Assisted Surgical Navigation Does Not Improve the Alignment and Orientation of the Components in Total Knee Arthroplasty, J Bone Joint Surg Am 2009; 91(1): 2-9.
  19. Lass R, Kubista B, Olischar B et al. Total hip arthroplasty using imageless computer-assisted hip navigation: a prospective randomized study. J Arthroplasty 2014; 29(4):786-91.
  20. Luring C, Beckmann J, Haibock P, et al, Minimal Invasive and computer Assisted Total Knee Replacement Compared with the Conventional Technique: A Prospective, Randomised Trial, Knee Surg Sports Traumatol Arthrosc. 2008 Oct; 16(10): 928-34.
  21. Lutzner J, Dexel J, Kirschner S. No difference between computer-assisted and conventional total knee arthroplasty: five-year results of a prospective randomised study. Knee Surg Sports Traumatol Arthrosc 2013; 21(10):2241-7.
  22. Manzotti A, et al, Does Computer-Assisted Surgery Benefit Leg Length Restoration in Total Hip Replacement? Navigation Versus Conventional Freehand, Int Orthop 2011; 35(1):19-24.
  23. Manzotti A, Pullen C, Confalonieri N, Computer-Assisted Alignment system for Tibial component Placement in Total Knee Replacement: A Radiological Study, Chir Organi Mov. 2008 Jan; 91(1): 7-11.
  24. Mullaji A, Shetty GM, Computer-Assisted Total Knee Arthroplasty for Arthritis with Extra-Articular Deformity, Journal of Arthroplasty 2009.
  25. Pang CH, et al, Comparison of Total Knee Arthroplasty Using Computer-Assisted Navigation Versus Conventional Guiding Systems: A Prospective Study, Journal of Orthopaedic Surgery 2009; 17(2): 170-3.
  26. Pearle AD, Kendoff D, Musahl V, Perspectives on Computer-Assisted Orthopaedic Surgery: Movement Toward Quantitative Orthopaedic Surgery, The Journal of Bone and Joint Surgery (American). 2009; 91: 7-12.
  27. Pierre-Louis Docquier, Laurent Paul, Olivier Cartiaux, Christian Delloye, and Xavier Banse, “Computer-Assisted Resection and Reconstruction of Pelvic Tumor Sarcoma,” Sarcoma, vol. 2010, Article ID 125162, 8 pages, 2010. doi:10.1155/2010/125162.
  28. Rebal BA, Babatunde OM, Lee JH et al. Imageless computer navigation in total knee arthroplasty provides superior short term functional outcomes: a meta-analysis. J Arthroplasty 2014; 29(5):938-44.
  29. Reininga IH, et al, Minimally Invasive and Computer-Navigated Total Hip Arthroplasty: A Qualitative and Systematic Review of the Literature, BMC Musculoskeletal Disorders 2010, 11:92.
  30. Tria AJ Jr., Minimally Invasive Total Knee Arthroplasty: Past, Present, and Future, Am J Orthop. 2007 Sep; 36(9 Suppl): 6-7.
  31. U.S. Food and Drug Administration (FDA), PiGalileo™ System 510(k) Premarket Notification, 05/12/06, accessed at fda.com on 05/12/08.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 03/23/17.

GUIDELINE UPDATE INFORMATION:

07/15/04

New Medical Coverage Guideline.

01/01/05

HCPCS update; 0055T revision.

07/15/05

Annual review; no change.

06/15/06

Annual review; no change in investigational status.

06/15/07

Annual review; investigational status maintained; reformatted guideline; references updated.

01/01/08

2008 HCPCS update: deleted 0054T, 0055T, and 0056T; Added 20985, 20986, 20987.

07/15/08

Annual review: position statement maintained, Description section and references updated.

01/01/09

Annual HCPCS coding update: added codes 0054T & 0055T; deleted codes 20986 and 20987.

06/15/09

Annual review: position statement maintained and references updated.

11/15/10

Annual review: position statement maintained and references updated.

09/15/11

Scheduled review; position statement maintained and references updated.

10/15/12

Annual review; position statement maintained and references updated.

09/15/13

Annual review; position statement maintained and references updated.

09/15/14

Annual review; position statement maintained, description section and references updated.

10/15/15

Annual review; position statement maintained, references updated.

04/15/17

Revision; Investigational position statement maintained, description section and references updated.

Date Printed: June 23, 2017: 11:39 AM