Patient-Specific Instrumentation (eg, Cutting Guides) for Joint Arthroplasty

POLICY NUMBER

A.7.01.144

DESCRIPTION

Patient-specific instrumentation has been developed as an alternative to conventional cutting guides for joint arthroplasty. Patient-specific cutting guides are constructed with the aid of preoperative 3-dimensional computed tomography or magnetic resonance imaging scans and proprietary planning software. The goals of patient-specific instrumentation are to increase surgical efficiency and to improve implant alignment and clinical outcomes.

Patient-specific instrumentation has been developed as an alternative to conventional cutting guides, with the goal of improving both alignment and surgical efficiency. A number of patient-specific cutting guides are currently being marketed. Patient-specific guides are constructed with the use of preoperative 3-dimensional computed tomography or magnetic resonance imaging scans, which are taken 4 to 6 weeks before the surgery. The images are sent to the planner/manufacturer to create a 3-dimensional model of the knee and proposed implant. After the surgeon reviews the model of the bone, makes adjustments, and approves the surgical plan, the manufacturer fabricates the disposable cutting guides.

There are several commercially available patient-specific instrumentation systems for total knee arthroplasty. In 2008, the Smith & Nephew Patient Matched Instrumentation (now called Visionaire™ Patient Matched Instrumentation) was the first patient-specific cutting guide to receive the U.S. Food and Drug Administration (FDA) clearance for marketing. Other systems cleared for marketing by the FDA are shown in the table below.

Patient-Specific Cutting Guides for Knee Arthroplasty

Source: FDA: U.S. Food and Drug Administration.

POLICY

Use of patient-specific instrumentation (eg, cutting guides) for joint arthroplasty, including but not limited to use in unicompartmental or total knee arthroplasty, is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

The preplanning for the surgery may involve magnetic resonance imaging or computed tomography, which may help to identify these procedures.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

11/20/2014: New policy added. Approved by Medical Policy Advisory Committee.

08/03/2015: Code Reference section updated for ICD-10.

11/20/2015: Policy reviewed. Policy statements unchanged. Investigative definition updated in policy guidelines section.

05/31/2016: Policy number A.7.01.144 added.

09/15/2017: Policy description updated regarding patient-specific cutting guide systems. Policy statement unchanged.

03/13/2019: Policy title changed from "Patient-Specific Cutting Guides and Custom Knee Implants" to "Patient-Specific Instrumentation (eg, Cutting Guides) for Joint Arthroplasty." Policy description updated to remove information regarding custom implants and added information regarding outcome measures and patient-specific cutting guide systems. Custom implants removed from policy statement.

05/10/2019: Policy description updated regarding devices. Policy statement unchanged.

06/11/2020: Policy description updated regarding patient-specific instrumentation. Policy statement unchanged.

07/15/2021: Policy reviewed; no changes.

06/07/2022: Policy description updated regarding patient-specific instrumentation. Policy statement unchanged.

05/23/2023: Policy reviewed. Policy statement unchanged. Policy Guidelines updated.

05/20/2024: Policy reviewed; no changes.

05/08/2025: Policy description updated regarding devices. Policy statement unchanged.

SOURCE(S)

Blue Cross and Blue Shield Association Policy # 7.01.144

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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