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Date Printed: August 22, 2017: 07:03 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-20000-26

Original Effective Date: 09/15/03

Reviewed: 04/25/13

Revised: 05/15/13

Subject: Unicondylar Interpositional Spacer Devices

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates  

DESCRIPTION:

Osteoarthritis of the knee is typically a bilateral disease; however some patients may have signs or symptoms confined to the medial or lateral compartment. This is often the result of a specific injury. Initial treatment of osteoarthritis may include analgesics, viscosupplementation, and arthroscopic debridement. When patients fail to respond to these more conservative therapies, surgical interventions may be indicated. Older patients with arthritis typically consider total knee arthroplasty. Younger patients are usually not considered ideal candidates for total knee arthroplasty since they would be expected to need at least one additional total knee replacement in their lifetimes.

Metallic interpositional unicondylar spacers have been developed as possible alternatives to osteotomy or arthroplasty. The device is a U-shaped metallic shim, designed to be implanted in the knee joint following removal of any damaged cartilage. These devices do not require any bone resection or mechanical fixation for proper function. Following debridement and resection of the meniscus, the device is fit to the joint space above the affected tibial plateau and held in place by its geometry, ligament tension and the surrounding soft tissue structures. The uncemented implant adapts to the kinematics of the knee, with a smooth metallic curved surface against which the femur articulates. Preservation of bone is important for the use of interpositional spacers as a bridge procedure in active young adults or for overweight patients who would not be candidates for arthroplasty. These devices are intended to restore the stability and alignment of the knee and relieve pain, thereby delaying or avoiding the need for total knee arthroplasty (TKA).

Various devices are regulated by the U.S. Food and Drug Administration (FDA) through the 510(k) marketing process in the United States. The Unicondylar Interpositional Spacer Device received approval in 2001, and the OTI Unicondylar Interpositional Spacer Device was approved in 2002. The Knee Interpositional Mini-Repair System was granted approval in 2003. In 2006, the Orthoglide® Medial Knee Implant was approved, and in 2008, the OrthoGlide® Lateral Knee Implant received clearance.

POSITION STATEMENT:

Unicondylar interpositional spacer devices (e.g., UniSpacer) are considered experimental or investigational for treating any condition, and specifically to treat unicompartmental arthritis of the knee. There is insufficient published clinical evidence to support the safety, efficacy or improved long-term outcomes for these devices as an alternative to osteotomy and arthroplasty.

BILLING/CODING INFORMATION:

There are no specific CPT or HCPCS codes that describe unicondylar interpositional spacer devices.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Arthroplasty: surgical repair of a joint.

Osteotomy: the cutting of bone.

Unicompartmental: related to either the inside (medial) or outside (lateral) half of the knee joint.

RELATED GUIDELINES:

Autologous Chondrocyte Implantation (ACI), 02-20000-17

OTHER:

Other index terms:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

Knee interpositional spacer
Knee Interpositional Mini Repair System
OrthoGlide® Medial Knee Implant
OrthoGlide® Lateral Knee Implant
UniSpacer
OTI Unicondylar Interpositional Spacer Device
Unicondylar Interpositional Spacer Device

REFERENCES:

  1. AHRQ National Guideline Clearinghouse. Guideline Summary NGC-7155. American Academy of Orthopaedic Surgeons treatment of osteoarthritis of the knee (non arthroplasty). 2008 Dec. (Accessed 03/29/13).
  2. AHRQ National Guideline Clearinghouse. Guideline Summary NGC-8516. Knee & leg (acute & chronic). Work Loss Data Institute; 2011.
  3. Blue Cross Blue Shield Association Medical Policy Reference Manual. 7.01.88 Unicondylar Interpositional Spacer as a Treatment of Unicompartmental Arthritis of the Knee. (09/10/09).
  4. California Technology Assessment Forum (CTAF). Knee Joint Spacer (UniSpacer) System for Osteoarthritis of the Knee. (02/12/03) (Accessed 03/29/13).
  5. Catier C, TurcatM, Jacquel A, Baulot E. The UnispacerTM unicompartmental knee implant: Its outcomes in medial compartment knee osteoarthritis. Orthopaedics & Traumatology: Surgery & Research (2011) 97, 410—417.
  6. Clarius M, Becker JF, Schmitt H, Seeger JB. The UniSpacer™: correcting varus malalignment in medial gonarthrosis. International Orthopaedics (SICOT) (2010) 34:1175–1179.
  7. ClinicalTrials.gov NCT01564641: Study With the ConforMIS iDuo(R) G2. ConforMIS, Inc. Last updated 11/07/12.
  8. ECRI Health Technology Trends. A custom knee implant made to order: One company’s novel approach to bone sparing knee surgery. October 2008.
  9. ECRI Health Technology Assessment Information Services. Custom Hotline Response. UniSpacer System for Osteoarthritis of the Knee. (02/17/05).
  10. ECRI HTAIS Hotline Service Custom Reports. Unicondylar Interpositional Spacer Systems for Osteoarthritis of the Knee. Updated 04/27/06.
  11. Goble EM, Justin DF. Minimally invasive total knee replacement: principles and technique. Orthop Clin N Am. 2004 Apr; 35(2): 235-245.
  12. Koeck FX, Luring C, Goetz1 J, Handel1 M, Tingart M, Grifka J, Beckmann J. Prospective Single-Arm, Multi-Center Trial of a Patient-Specific Interpositional Knee Implant: Early Clinical Results. The Open Orthopaedics Journal, 2011, 5, 37-43.
  13. Koeck FX, Perlick L, Luring C, Handel M, Beckmann J, Linhardt O, Grifka J. Leg axis correction with ConforMIS iForma™ (interpositional device) in unicompartmental arthritis of the knee. International Orthopaedics (SICOT) (2009) 33:955–960.
  14. National Institute for Health and Clinical Excellence (NICE). Interventional Procedure Guidance (IPG) 317: Individually magnetic resonance imaging-designed unicompartmental interpositional implant insertion for osteoarthritis of the knee. September 2009.
  15. Repicci JA, Hartman JF. Minimally invasive unicondylar knee arthroplasty for the treatment of unicompartmental osteoarthritis: an outpatient arthritic bypass procedure. Orthop Clin North Am. 2004 Apr; 35(2): 201-16.
  16. Sisto DJ, Mitchell IL. UniSpacer arthroplasty of the knee. J Bone Joint Surg Am. 2005 Aug; 87(8): 1706-11.
  17. Tice JA. Knee joint spacer (UniSpacer) system for osteoarthritis of the knee. Technology Assessment. San Francisco, CA: California Technology Assessment Forum; February 13, 2003.
  18. U.S. Food and Drug Administration (FDA). 510(k) summary: Sulzer Orthopedics Unicondylar Interpositional Spacer.
  19. U.S. Food and Drug Administration (FDA). 510(k) summary: Advance Bio-Surfaces, Inc. OrthoGlide® Lateral Knee Implant.
  20. U.S. Food and Drug Administration (FDA). 510(k) summary: Advance Bio-Surfaces, Inc. OrthoGlide® Medial Knee Implant.
  21. U.S. Food and Drug Administration (FDA). 510(k) summary: Imaging Theraputics, Inc. Knee Interpostional Mini- Repair Systems.
  22. U.S. Food and Drug Administration (FDA). 510(k) summary: Osteoimplant Technology, Inc. OTI Unicondular Interpositional Spacer.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/25/13.

GUIDELINE UPDATE INFORMATION:

09/15/03

New Medical Coverage Guideline; investigational.

07/15/04

Review to guideline with no changes made; maintain investigational status.

07/15/05

Review and revision of guideline; consisting of updated references and maintain investigational status.

06/15/06

Review and revision of guideline consisting of updated references.

05/15/07

Review and revision of guideline consisting of updated references and reformatted guideline.

05/15/08

Scheduled review; no change in position statement. Update references.

05/15/09

Scheduled review; no change in position statement.

05/15/10

Annual review; no change to position statement, and updated references.

05/15/12

Scheduled review; no change in position statement. Updated description section, index terms and references.

05/15/13

Scheduled review; no change in position statement. Revised MCG title, description and definitions. Updated references.

Date Printed: August 22, 2017: 07:03 AM