Medical Policy: 06.01.24
Original Effective Date: January 2007
Reviewed: August 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Computer-assisted navigation systems integrate preoperative planning and intraoperative execution information by displaying three dimensional (3D) computer images in relation to patient anatomy. These systems consist of a computer workstation with image processing and surgical planning software, a localization/digitization system and a display monitor. Computer software enables the surgeon to measure distances, angles, and volumes, and rotate and zoom to determine cutting planes and implant positioning.
Computer-assisted navigation involves three processes: data acquisition, registration, and tracking. Data can be acquired in three different ways including fluoroscopic, computed tomographic (CT) or magnetic resonance imaging (MRI)-guided or imageless systems. Registration establishes a spatial relationship between all image locations and the corresponding locations on the patient. A surface-matching technique can be used in which the shapes of the bone surface model generated from preoperative images are matched to surface data points collected during surgery. Tracking refers to the sensors and measurement devices that can provide feedback during surgery regarding the orientation and relative position of tools to bone anatomy providing real-time information.
Computer-assisted navigational surgical techniques are emerging as an adjunct to fixation of pelvic, acetabular, or femoral fractures, and as an adjunct to hip and knee arthroplasty procedures.
The existing literature provides insufficient evidence to determine whether using computer-assisted navigation systems for orthopedic surgery reduces post-procedure complications and impacts functional outcomes and long-term effects, including implant longevity, need for revision, pain, and quality of life.
Computer-assisted navigation as an adjunct to orthopedic procedure(s) is considered investigational.
Scientific evidence at this time has not adequately demonstrated improved health outcomes with the use of computer-assisted navigation. Studies that assess health outcomes in a larger number of subjects with longer follow-up are needed. Therefore, computer assisted navigation as an adjunct to orthopedic procedure(s) is considered investigational.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 20985 Computer-assisted surgical navigational procedure for musculoskeletal procedures; image-less (List separately in addition to code for primary procedure)
- 0054T Computer-assisted musculoskeletal surgical navigational orthopedic procedure, with image-guidance based on fluoroscopic images (List separately in addition to code for primary procedure)
- 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)
- Leenders T, Vandevelde D, Mahieu G et al. Reduction in variability of acetabular cup abduction using computer assisted surgery: a prospective and randomized study. Comput Aided Surg. 2002; 7(2):99-106.
- Sparmann M, Wolke B, Czupalla H et al. Positioning of total knee arthroplasty with and without navigation support. A prospective, randomised study. J Bone Joint Surg Br. 2003 Aug;85(6):830-5.
- Digioia AM 3rd, Jaramaz B, Plakseychuk AY et al. Comparison of a mechanical acetabular alignment guide with computer placement of the socket. J Arthroplasty. 2002 Apr;17(3):359-64.
- Haaker RG, Stockheim M, Kamp M et al. Computer-assisted navigation increases precision of component placement in total knee arthroplasty. Clin Orthop Relat Res. 2005 Apr; (433):152-9.
- Keene G, Simpson D, Kalairajah Y. Limb alignment in computer-assisted minimally-invasive unicompartmental knee replacement. J Bone Joint Surg Br. 2006 Jan; 88(1):44-8.
- Hufner T, Meller R, Kendoff D et al. The role of navigation in knee surgery and evaluation of three-dimensional knee kinematics. Oper Techniq Orthop 2005; 15(1):64-9.
- Stulberg SD, Loan P, Sarin V. Computer-assisted navigation in total knee replacement: results of an initial experience in thirty-five patients. J Bone Joint Surg Am 2002; 84-A Suppl: 90-8.
- Schep NW, Broeder IA, van der Werken C. Computer-assisted orthopaedic and trauma surgery. State of the art and future perspectives. Injury 2003; 34(4):299-306.
- Decking R, Markmann Y, Fuchs J et al. Leg axis after computer navigated total knee arthroplasty: a prospective randomized trial comparing computer-navigated and manual implantation. J Arthroplasty 2005; 20(3):282-8.
- Hamelinck HK, Haagmans M, Snoeren MM, Biert J, Van Vugt AB, Safety of computer-assisted surgery for cannulated hip screws. Clin Orthop Relat Res. 2007 Feb;455-241-5.
- Heffner T, Kendoff D, Citak M, Geerling J, Krettek C, Precision in orthopaedic computer navigation. Orthopade.2006 Oct;35(10)1043-55.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) Assessment Program. Computer-Assisted Navigation for Total Knee Arthroplasty. Vol. 22, No. 10. February 2008.
- ECRI Institute. Computer-assisted Navigation for Total Knee Replacement. Plymouth Meeting (PA): ECRI InstituteExternal Site; 2008 August 29. 11 p. [ECRI hotline response]. .
- ECRI Institute. Computer-assisted Navigation for Total Hip Replacement. Plymouth Meeting (PA): ECRI InstituteExternal Site; 2008 August 29. 9p. [ECRI hotline response].
- Health technology forecast [database online]. Plymouth Meeting (PA): ECRI InstituteExternal Site; 2008 Jan 9. [updated 2010 Jun 6]. Image-guided surgery systems for joint replacement.
- Ishida K, Matsumoto T, Tsumura N, et al. Mid-term outcomes of computer-assisted total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1107-12.
- Manzotti A, Cerveri P, De Momi E, et al. Does computer-assisted surgery benefit leg length restoration in total hip replacement? Navigation versus conventional freehand. Int Orthop. 2011 Jan;35(1):19-24.
- ECRI. Computer-assisted Navigation for Improving Clinical Outcomes after Total Joint Arthroplasty. Plymouth Meeting (PA): ECRI InstituteExternal Site. Health Technology Assessment Information Service; 2012 August 21. [Hotline Response].
- Burnett RS & Barrack RL. Computer-assisted total knee arthroplasty is currently of no proven clinical benefit: a systematic review. Clin Orthop Relat Res. 2012 Sep 5. [epub ahead of print]
- Harvie P, Sloan K, and Beaver RJ. Computer navigation vs conventional total knee arthroplasty: five-year functional results of a prospective randomized trial. J Arthroplasty. 2012 May;27(5):667-72.
- Yaffe M, Patel A, et al. Component sizing in total knee arthroplasty: patient-specific guides vs.computer -assisted navigation. Biomedical Engineering 2012 Apr:57(4):277-82.
- Faculty of Health and Social Sciences. Unicompartmental Knee Arthroplasty: A Perspective from Computer Assisted Navigation. International Journal of Clinical Medicine. 2013 Jun(4) 20-22.
- Blyth MG, Smith JR, et. al., Electromagnetic Navigation in Total Knee Arthroplasty – A Single Center, Randomized, Single Blind Study Comparing the Results with Conventional Techniques, J Arthroplasty 2015 February 30(2):199-205
August 2015 - Annual Review, Policy Renewed
September 2014 - Annual Review, Policy Renewed
October 2013 - Annual Review, Policy Renewed
December 2012 - Annual Review, Policy Renewed
December 2011 - Annual Review, Policy Renewed
December 2010 - Annual Review, Policy Renewed
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.