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Computer-Assisted Musculoskeletal Surgical Navigational Orthopedic Procedure
MA11.088c

Policy

Although the US Food and Drug Administration (FDA) has approved several surgical navigational systems used in computer-assisted musculoskeletal surgical navigational orthopedic procedures, the Company has determined that the safety and/or the effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature. Therefore, computer-assisted musculoskeletal surgical navigational orthopedic procedures are considered experimental/investigational by the Company and not covered.

Guidelines

There is no Medicare coverage determination addressing computer-assisted musculoskeletal surgical navigational orthopedic procedures; therefore, the Company policy is applicable.

The Current Procedural Terminology (CPT) codes for computer-assisted musculoskeletal surgical navigational orthopedic procedures are based on how data acquisition is acquired (CPT 0054T fluoroscopic, 0055T MRI/CT).

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, a computer-assisted musculoskeletal surgical navigational orthopedic procedure is not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are excluded for the Company's Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA)

There are numerous devices approved by the FDA for surgical navigational systems. Examples of such navigational systems are the GE OEC Fluorostar™ and the OEC Olympus Mobile Fluoroscopy System with Integrated Navigation.

Description

Computer-assisted navigational orthopedic procedures use navigational systems during musculoskeletal surgery to provide additional information and to further integrate preoperative planning with how the surgery is being performed. Navigational systems are typically used to improve placement and positioning of a prosthetic and/or surgical instrument during the procedure. Computer-assisted navigational orthopedic procedures can also be used as an adjunct to fixation of pelvic, acetabular, or femoral fractures, and as an adjunct to hip or knee arthroplasty procedures.

The navigational systems require three steps to gather information: data acquisition, registration, and tracking. Data acquisition is obtained in one of three ways: fluoroscopic imaging, computer tomography (CT), magnetic resonance imaging (MRI), or through an imageless system. The data is then used for registration and tracking. Registration refers to how the images (e.g., X-rays, CT, MRI) relate to the anatomical position in the surgical field. Surface-matching techniques are often used for matching shapes of bones before surgery to surface data points during surgery. Tracking refers to the sensor and measurement devices that report the position and orientation of the instruments and/or the placement and orientation of the implants relative to the bone anatomy during surgery.

PEER-REVIEWED LITERATURE

In a meta-analysis, Bauwens et al. (2007) evaluated the available peer-reviewed literature on computer-navigated knee arthroplasties. Thirty-three studies, including 11 randomized trials were reviewed, representing 3,423 individuals with a mean age of 67.3 years. The authors noted that there was no evidence of publication bias, though there was strong statistical heterogeneity in the studies. The alignment of the mechanical axes did not differ between the navigated or conventional surgery groups, though participants managed with navigated surgery had a lower risk of malalignment at critical thresholds of greater than 3 degrees. The authors concluded that computer-navigated knee replacement offered few advantages over conventional surgery and that the clinical benefits were unclear and remained to be determined on a larger scale.

In a prospective randomized controlled trial, Mueffels et al. (2012) evaluated the effectiveness of computer-assisted anterior cruciate ligament (ACL) reconstruction. One hundred individuals eligible for ACL reconstruction with a transtibial technique were randomized to either conventional or computer-navigated surgery. Measurement of femoral and tibial tunnel placement with use of three-dimensional computed tomography was used as the primary outcome measurement. The placement of either the femoral or tibial tunnels did not have a statistically significant difference between the groups. The authors concluded that there was no significant difference in either the accuracy or precision of tunnel placement between conventional and computer-navigated ACL reconstruction.

In an updated Cochrane systematic review, Eggerding et al. (2014) evaluated the effectiveness of computer-navigated surgery for knee ligament reconstruction. Five randomized controlled trials were included, representing 366 participants. All studies involved ACL reconstructions. The authors found moderate-quality evidence of no clinically relevant difference between computer-navigated and conventional surgery when reviewing the International Knee Documentation Committee subjective scores (i.e., self-reported measure of knee function). Pooled data from two of the studies showed a small but clinically irrelevant difference favoring computer-navigated surgery. The authors concluded that based on the available evidence, they were unable to demonstrate a favorable effect of computer-navigated surgery for cruciate ligament reconstructions of the knee when compared to conventional reconstructions.

Lass et al. (2020) conducted a two-year follow-up prospective randomized study comparing computer-assisted to manual implantation techniques in total hip arthroplasty (THA). The study analyzed if computer-assisted surgery can improve the clinical and functional results and reduce dislocation rate shortly after THA. Although a significant difference was found in mean postoperative acetabular component anteversion and in outliers regarding inclination and anteversion (p < 0.05) between computer-assisted navigation and the manual placed group, no significant difference regarding clinical outcome or revision rates at short-term or 2-year follow-up were found. Therefore, further long-term follow-up of patient groups is needed.

 

In a meta-analysis, Lee et al. (2020) compared mid-to long-term clinical outcomes and radiological outcomes between computer navigated total knee arthroplasty (TKA) and conventional TKA. The study analyzed seven randomized controlled trials where no significant difference was found in radiologic outcomes and clinical outcomes in the two techniques. The authors concluded that it was unclear which TKA technique yielded better results in terms of mid-to long-term clinical and radiological outcomes.

 

A systematic review published by Kunze et al (2023) compared surgical time, short-term adverse events, and implant placement accuracy between manual, robotic-assisted, and computer-navigated total hip arthroplasties (THAs)., Seven RCTs were identified comparing computer-assisted navigation and manual THAs.  The authors found manual THA resulted in significantly shorter surgical times and a similar incidence of complications and revisions compared to computer-assisted THA. However, computer-assisted navigation THA led to increased precision in the placement of acetabular implants. These results are limited by a lack of recent RCTs, inability to conduct meta-analysis of patient-reported outcome measures, and use of the Lewinnek safe zone as a benchmark for proper acetabular implant positioning, which may not be appropriate in all individuals. Additionally, there were a variety of computer-assisted navigation systems used across the RCTs, limiting conclusions regarding any particular system.

​SUMMARY


Computer-assisted navigation systems used in musculoskeletal surgical orthopedic procedures have been proposed to facilitate alignment and reduce the chance for malposition. While there are numerous devices approved by the US Food and Drug Administration (FDA) for surgical navigational systems, these systems are typically only subject to 510(k) approval because they serve as an adjunct to surgery rather than actually performing the surgery. In addition, the available published peer-reviewed literature has not demonstrated improved health outcomes for individuals.

References

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Kim YH, Kim JS, Choi Y, 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):14-9.

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Kunze KN, Bovonratwet P, Polce EM, et al. Comparison of Surgical Time, Short-term Adverse Events, and Implant Placement Accuracy Between Manual, Robotic-assisted, and Computer-navigated Total Hip Arthroplasty: A Network Meta-analysis of Randomized Controlled Trials. J Am Acad Orthop Surg Glob Res Rev. 2022; 6(4). 

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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;35(1):19-24.

Matziolis G, Krocker D, Weiss U, et al. A prospective, randomized study of computer-assisted and conventional total knee arthroplasty: three-dimensional evaluation of implant alignment and rotation. J Bone Joint Surg Am. 2007;89:236-243.

Mauch F, Apic G, Becker U, Bauer G. Differences in the placement of the tibial tunnel during reconstruction of the anterior cruciate ligament with and without computer-assisted navigation. Am J Sports Med. 2007;35(11):1824-1832.

Meuffels DE, Reijman M, Scholten RJ, et al. Computer assisted surgery for knee ligament reconstruction. Cochrane Database Syst Rev. 2011; (6):CD007601.

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Coding

CPT Procedure Code Number(s)
0054T, 0055T, 20985

THE FOLLOWING CODE IS USED TO REPRESENT INTRA-OPERATIVE USE OF KINETIC BALANCE SENSOR FOR IMPLANT STABILITY DURING KNEE REPLACEMENT ARTHROPLASTY:

​27599​
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
This service is experimental/investigational for all diagnoses.
HCPCS Level II Code Number(s)
N/A
Revenue Code Number(s)
N/A


Coding and Billing Requirements

Policy History

1/1/2024
1/1/2024
3/6/2024
MA11.088
Medical Policy Bulletin
Medicare Advantage
No