ModifiedUnitedHealthcarePolicy CS167OH.D

Computer-Assisted Surgical Navigation for Musculoskeletal Procedures (for Ohio Only)

Defines UnitedHealthcare Ohio coverage stance on computer-assisted surgical navigation (CAN) for musculoskeletal procedures of the pelvis and appendicular skeleton and related intraoperative sensor use, applying to providers and claims in Ohio.

Policy Summary

PayerUnitedHealthcare

PolicyComputer-Assisted Surgical Navigation for Musculoskeletal Procedures (for Ohio Only)

Policy CodePolicy CS167OH.D

Change TypeCoverage rationale and coding language revised

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionVerify Ohio plan benefits and medical necessity prior to performing CAN or intra-operative sensor use; services deemed unproven may be denied.

SourceLink

POLICY UPDATE CHANGES

Replaced language indicating use of intra-operative kinetic balance sensor for implant stability during knee replacement arthroplasty is unproven and not medically necessary with wording that the use of an intra-operative sensor for implant stability during knee replacement arthroplasty and for improved knee function post-operatively is unproven and not medically necessary.

Revised description for CPT code 27599.

Replaced notation indicating intra-operative use of kinetic balance sensor is incidental and not eligible for separate reimbursement with wording that intra-operative use of a sensor for implant stability during knee replacement arthroplasty is incidental and not eligible for separate reimbursement.

Ohio-onlyjurisdiction

Pelvis & appendicularanatomic focus

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Coverage Determinations

Not medically necessary — pelvis and appendicular CAN and intra-operative knee sensors

Covered when ALL of the following are met:

Main policy stance: Computer-assisted surgical navigation for musculoskeletal procedures of the pelvis and appendicular skeleton is unproven and not medically necessary due to insufficient evidence of efficacy.

Includes intra-operative sensors for implant stability during knee replacement arthroplasty and for improved knee function post‑operatively; these are also unproven and not medically necessary.

Coverage rationale — CAN and intra-operative sensors

Summary of evidence and rationale:

CAN general: Computer-assisted navigation has demonstrated improved precision of component alignment or placement in some studies, but evidence does not show consistent improvement in patient‑oriented clinical outcomes or complications for total knee arthroplasty (TKA); AAOS guidance states strong evidence to support not using intraoperative navigation in TKA due to no difference in outcomes or complications.

Supported by AAOS guideline and multiple trials/meta-analyses

Other appendicular/pelvic indications: For non‑hip/knee appendicular and pelvic indications (including preliminary upper extremity and axial skeleton uses), the literature is limited and while technical precision may improve, clinical outcome benefit is unclear; additional controlled studies measuring health outcomes are needed.

Based on small RCTs, retrospective cohorts, and preliminary studies showing trends but not statistically significant clinical improvements

TKA sensors: Intra‑operative sensors for TKA can reduce measurable intraoperative imbalance and have been associated with fewer manipulations under anesthesia in pooled analyses, but randomized trials and meta-analyses have not demonstrated consistent improvements in function, reoperation, or patient satisfaction at medium‑term follow‑up; therefore use for implant stability and to improve post‑operative knee function is unproven.

Evidence includes meta-analysis showing reduced manipulation under anesthesia but no significant improvement in function, and RCTs with no difference in 1‑year outcomes despite improved intraoperative balance

Intra-operative use of a sensor for implant stability during knee replacement arthroplasty is considered incidental to the primary procedure being performed and is not eligible for separate reimbursement. This coding clarification aligns with the policy's guidance that sensor use during the index arthroplasty is part of the primary surgical service and should not be billed or adjudicated as an additional, separately payable procedure.

Policy language has been revised to use broader, neutral terminology. The prior phrasing referencing a "kinetic balance sensor" has been replaced with wording that refers to "a sensor" for implant stability, and the coverage rationale was updated to explicitly state that intra-operative sensor use for implant stability and for improved knee function post-operatively is unproven and not medically necessary.

UnitedHealthcare Ohio considers computer-assisted surgical navigation (CAN) for musculoskeletal procedures of the pelvis and appendicular skeleton to be unproven and not medically necessary due to insufficient evidence of efficacy. Likewise, the policy finds that intra-operative sensors used during total knee arthroplasty for implant stability are unproven and not medically necessary. The policy therefore does not support separate coverage or payment for CAN in these anatomic regions or for intra-operative sensors in TKA.

Available evidence shows intra-operative sensors can reduce measurable intraoperative imbalance and may reduce some immediate interventions (for example, lower rates of manipulation under anesthesia in pooled analyses), but randomized trials have not demonstrated consistent improvements in patient-reported function or satisfaction at intermediate follow-up. Consequently, the policy states that the use of an intra-operative sensor for implant stability during knee replacement arthroplasty — and its use with the intent to improve post-operative knee function — is unproven and not medically necessary.

Procedure and Device Coding

Codes addressed in policyCPT

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)
20985	Computer-assisted surgical navigational procedure for musculoskeletal procedures, image-less (List separately in addition to code for primary procedure)
27599	Unlisted procedure, femur or knee (e.g., sensor)

Applicable CPT adjustments notedCPT

27599

Revised description for CPT code 27599 (policy indicates description was revised)

Regulatory clearances / device listingsmixed

FDA 510(k)

Regulatory pathway used for many surgical navigation systems (informational)

Intercompartmental pressure variance threshold used in trial

Intercompartmental pressure variance threshold15 pounds (target used to define a 'balanced' knee in the randomized trial)

Definition in trial contextKnees were considered balanced if intercompartmental pressure variance was within 15 pounds.

Comparison outcomeTrial showed fewer unbalanced knees in sensor-guided group versus control using the 15-pound threshold (5.3% vs 36%, p < .001).

Provider Requirements and Billing Guidance

Prior Authorization

Prior Authorization and Medical Necessity

Prior authorization and medical necessity review for services described in this policy are governed by the Ohio-only policy. Any requests for services that are stated as unproven or services for which there is a coverage or quantity limit will be evaluated for medical necessity using Ohio Administrative Code 5160-101. Providers must obtain any required prior authorization per UnitedHealthcare procedures before scheduling or performing services.

Prior authorization required when plan or contractual terms mandate it; verify prior authorization requirements with UnitedHealthcare prior to service.
Medical necessity determinations for CAN services and intra-operative sensors in Ohio will be made using OAC 5160-101.

Note

Verify Benefit and Governing Criteria

Verify member benefit coverage, plan limitations, and any federal, state (OAC) or contractual requirements before providing services. This policy is informational and does not replace verification of benefits. In the event of a conflict, federal, state (OAC) or contractual requirements govern.

Check the member's specific UnitedHealthcare plan for coverage of computer-assisted surgical navigation (CAN) and intra-operative sensors.

Clinical and Technical Background

Computer-assisted navigation (CAN) encompasses image-based and imageless systems that guide implant placement and alignment in musculoskeletal surgery. Typical CAN workflow includes data acquisition (via fluoroscopy, CT, MRI, or imageless methods), registration (relating images to patient anatomy), and tracking (using optical or electromagnetic sensors). CAN systems seek to improve technical precision of component alignment, but improved radiographic alignment has not consistently translated into better patient-oriented clinical outcomes in pelvis and appendicular skeletal procedures.

Definitions and Key Terms

Appendicular Skeleton System definition

ScopeIncludes the bones of the shoulder girdle, the upper limbs, pelvic girdle, and the lower limbs.

ExamplesShoulder, arm, pelvis, thigh, leg, and associated girdles.

ContextTerm used to specify anatomic regions addressed by CAN policy (appendicular skeletal procedures).

Musculoskeletal System definition

Core definitionProvides form, support, stability, and movement to the body and is made up of bones, muscles, cartilage, tendons, ligaments, joints, and other connective tissue.

FunctionSupports and binds tissues and organs; enables movement and stability.

Policy Revision History

2025-01-01policy_revisionLatest

Coverage rationale revised to state that use of an intra-operative sensor for implant stability during knee replacement arthroplasty and for improved post-operative knee function is unproven and not medically necessary; CPT code 27599 description revised; language changed from 'kinetic balance sensor' to 'a sensor' and incidental-use reimbursement note clarified.