RetiredCapital BluecrossPolicy MP 1.106

COMPUTER ASSISTED NAVIGATION FOR ORTHOPEDIC PROCEDURES

Defines Capital BlueCross medical policy MP 1.106 on computer-assisted (surgical) navigation for orthopedic procedures, including applicability to products, background, evidence summary, device examples, coding, and benefit variation notes. Policy states the procedure is considered investigational due to insufficient evidence of improved health outcomes.

Policy Summary

PayerCapital Bluecross

PolicyCOMPUTER ASSISTED NAVIGATION FOR ORTHOPEDIC PROCEDURES

Policy CodePolicy MP 1.106

Change TypeRetired (management moved to Turning Point policy OR-1035.23)

Effective DateRETIRED 9/1/2024

Next Review Date

Key ActionBenefit determinations must be based on the member's health benefit plan language and may require preauthorization per the plan.

POLICY UPDATE CHANGES

05/24/2022 - Minor review: Policy statement changed by removing 'pelvis and appendicular skeleton'.

05/22/2024 - Policy retired; management moved to Turning Point policy OR-1035.23.

Multiple historical administrative updates and consensus reviews with no change to policy statement recorded between 2004 and 2023.

1Current coverage stance

3Procedure codes listed

2024Year retired

Coverage Summary & Determination

Computer-assisted navigation for orthopedic procedures (policy MP 1.106) is designated as investigational. The policy states there is insufficient evidence to support a general conclusion that computer-assisted surgical navigation improves health outcomes or provides net clinical benefit for orthopedic procedures.

Status: RETIRED (effective 9/1/2024). The policy was retired 05/22/2024 and management of computer-assisted navigation for orthopedic procedures was moved to Turning Point policy OR-1035.23; the policy record indicates prior FDA/510(k) device context and ongoing background material retained for reference.

Policy dates and status

Policy NumberMP 1.106

Last Review2024-05-22

StatusRETIRED

Retired Year2024

Policy coverage determination

Computer-assisted surgical navigation for orthopedic procedures is considered investigational.

There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Medical Necessity Criteria & Evidence Summary

Policy coverage determination

Computer assisted surgical navigation for orthopedic procedures is considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure. Authoritative source for medical necessity: Primary coverage determination captured in policy MP 1.106.

Computer-assisted surgical navigation for orthopedic procedures is considered investigational.

There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

The evidence base includes randomized controlled trials and systematic reviews across indications. For total knee arthroplasty (TKA), multiple RCTs and systematic reviews showed few consistent differences in clinical or functional outcomes versus conventional techniques and most commonly reported an increase in operative time with navigation when differences were present. For spine surgery, navigation is consistently associated with lower rates of pedicle screw perforation, but trials and observational data have not consistently demonstrated improvements in patient-oriented clinical outcomes (for example, revision rates), and long-term outcome data are lacking. Overall, results are inconsistent and insufficient to demonstrate clear patient-oriented benefit.

Definitions

510(k)A premarketing submission to FDA to demonstrate that the device is substantially equivalent to a legally marketed device not subject to PMA.

Computed Axial TomographyImaging technique that reconstructs cross-sections using computer-enhanced tomographic images.

Provider Actions & Billing Guidance

Documentation Required

Benefit determination requirement

The existence of this medical policy does not mean the service is a covered benefit; benefit determinations must be based on the member's health benefit plan language and may require preauthorization per the plan.

Billing Rule

Coding review advisory

Codes listed in the policy may not be all-inclusive and identification of a code in the section does not denote coverage; not all covered services are eligible for separate reimbursement.

0054T
0055T
20985
Listing a code does not denote coverage; not all covered services are separately reimbursable.

Background & Scope

Computer-assisted navigation encompasses image-based and imageless tracking systems that assist implant alignment and tool positioning in knee, hip, spine, trauma, and ligament reconstruction procedures. The technology involves three core steps—data acquisition, registration, and tracking—and uses modalities such as fluoroscopy, computed tomography, magnetic resonance imaging, or intraoperative imageless registration to generate and relate 3-dimensional models to the surgical field.

Device examples include VERASENSE (OrthoSensor), iASSIST (Zimmer Biomet), PiGalileo, StealthStation (Medtronic), NuVasive Pulse, and many other systems that have received U.S. FDA 510(k) clearance for computer-assisted navigation in orthopedic surgery. Because these systems are considered surgical information systems, most have been cleared via the 510(k) process rather than the more rigorous premarket approval (PMA) process.

Despite device availability and 510(k) clearances, the policy concludes that evidence across indications is inconsistent and insufficient to demonstrate improvements in net health outcomes for orthopedic procedures.

LCD Name	Number	Type	Effective Date
L35094	L35094	LCD

Revision History

05/24/2022material_revision

Minor review: Policy statement changed by removing 'pelvis and appendicular skeleton'; Background, Rationale, and References revised; FEP language updated.

05/22/2024retirementLatest

Policy retired; computer-assisted navigation for orthopedic procedures is now managed by Turning Point policy OR-1035.23.

2004–2023administrative_history

Multiple administrative updates and consensus reviews recorded between 2004 and 2023 (including regular consensus reviews, coding updates, title changes, and reference/rationale updates) with no change to the core policy statement on many occasions.