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Date Printed: December 17, 2017: 04:17 PM

Private Property of Blue Cross and Blue Shield of Florida.
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.

02-20000-37

Original Effective Date: 11/15/09

Reviewed: 09/26/13

Revised: 10/15/13

Subject: Total Facet Arthroplasty

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   Previous Information

DESCRIPTION:

Facet arthroplasty refers to the implantation of a spinal prosthesis to restore posterior element structure and function as an adjunct to neural decompression. This procedure is proposed as an alternative to posterior spinal fusion for patients with facet arthrosis, spinal stenosis, and spondylolisthesis.

Spinal fusion is a common surgical treatment for degenerative disc disease when conservative treatment fails. However, spinal fusion alters the normal biomechanics of the back, which may potentially lead to premature disc degeneration at adjacent levels. A variety of implants have been investigated as alternatives to rigid interbody or posterolateral intertransverse spinal fusion. This policy addresses the implantation of prostheses intended to replace the facet joints and excised posterior elements, termed facet arthroplasty. The objective of facet arthroplasty is to stabilize the spine while retaining normal intervertebral motion of the surgically removed segment following neural decompression. It is proposed that facet arthroplasty should also maintain the normal biomechanics of the adjacent vertebrae.

No facet arthroplasty devices have been approved by the U.S. Food and Drug Administration (FDA) at this time. The ACADIA™ Facet Replacement System is currently being evaluated as part of an ongoing FDA-regulated investigational device exemption (IDE) Phase III trial. The Phase III trial of the Total Facet Arthroplasty System® (TFAS®) has been discontinued. Another implant design, the Total Posterior-element System (TOPS™), is in development and has restarted enrollment in a FDA-regulated Phase III trial in 2011, after design and manufacturing changes.

POSITION STATEMENT:

Total facet arthroplasty (facet replacement) is considered experimental or investigational for all indications including, but not limited to, the following:

There is a lack of sufficient clinical evidence published in peer-reviewed literature demonstrating the safety, efficacy, or the effects of facet arthroplasty (facet replacement) on health outcomes.

BILLING/CODING INFORMATION:

The following codes may be used to describe total facet arthroplasty:

CPT Coding

0202T

Posterior vertebral joint(s) arthroplasty (e.g. facet joint[s] replacement) including facetectomy, laminectomy, foraminectomy and vertebral column fixation, with or without injection of bone cement, including fluoroscopy, single level, lumbar spine (investigational)

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: The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services, (L29288) located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Artificial Intervertebral Discs, 02-20000-27
Interspinous Process Distraction Devices (Spacers), 02-20000-36

OTHER:

Index terms used for facet arthroplasty (facet replacement):

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.


ACADIA™ Facet Replacement System
Total Facet Arthroplasty System® (TFAS®)
Total Posterior-element System (TOPS™ System)

REFERENCES:

  1. AHRQ National Guideline Clearinghouse. NGC-8890. Cervical and thoracic spine disorders. Elk Grove Village (IL): American College of Occupational and Environmental Medicine (ACOEM); 2011. p. 1-332.
  2. AHRQ National Guideline Clearinghouse. NGC-9327. Low back disorders. Elk Grove Village (IL): American College of Occupational and Environmental Medicine (ACOEM); 2011. p. 333-796.
  3. AHRQ National Guideline Clearinghouse. NGC-6456. Low back disorders. Occupational medicine practice guidelines: evaluation and management of common health problems and functional recovery in workers. 2nd ed. Elk Grove Village (IL): American College of Occupational and Environmental Medicine (ACOEM); 2004. p. 286-326.
  4. Blue Cross Blue Shield Medical Policy Reference Manual. 7.01.120. Total Facet Arthroplasty. July 2013. (Accessed 08/19/13).
  5. ClinicalTrial.gov. A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis. Information provided by Facet Solutions, Inc. Identification number: NCT0000401518. (Accessed 08/19/13).
  6. ClinicalTrial.gov. Total Facet Arthroplasty System®(TFAS®) Clinical Trial. Information provided by Archus Orthopedics, Inc. Last updated February 4, 2009. Identification number: NCT00418197. (Accessed 09/01/11).
  7. ClinicalTrials.gov. Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis. Verified by Impliant, Ltd., February 2007. Last Updated: January 28, 2010. Identifier NCT00405691. (Accessed 10/07/10).
  8. Florida Medicare Part B Local Coverage Determination. LCD for Non-Covered Services (L29288). Revised 08/05/13. (Accessed 08/19/13).
  9. Manchikanti, L, Boswell, MV, Singh V, Benyamin RM, Fellows B, Salahadin A, Buenaventur RM, Conn A, Datta S, Derby R, Falco FJE, Erhart S, Diwan S, Hayek SM, Helm S, Parr AT, Schultz DM, Smith HS, Wolfer LR, & Hirsch JA. Comprehensive Evidence-Based Guidelines for Interventional Techniques in the Management of Chronic Spinal Pain. Pain Physician 2009; 12;699-802. (Accessed 08/19/13)
  10. North American Spine Society Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis. 2011. (Accessed 08/19/13).
  11. Phillips FM, Tzermiadianos MN, Voronov LI, et al. Effect of the Total Facet Arthroplasty System after complete laminectomy-facetectomy on the biomechanics of implanted and adjacent segments. Spine J 2009; 9(1): 96-102. (Accessed 09/01/11).
  12. Savigny P, Kuntze S, Watson P, Underwood M, Ritchie G , Cotterell M, Hill D, Browne N, Buchanan E, Coffey P, Dixon P, Drummond C, Flanagan M, Greenough,C, Griffiths M, Halliday-Bell J, Hettinga D, Vogel S, Walsh D. Low Back Pain: early management of persistent non-specific low back pain. London: National Collaborating Centre for Primary Care and Royal College of General Practitioners.
  13. Sjovold SG, et al. Biomechanical evaluation of the Total Facet Arthroplasty System (TFAS ): loading as compared to a rigid posterior instrumentation system. Eur Spine J (2012) 21:1660–1673.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/26/13.

GUIDELINE UPDATE INFORMATION:

11/15/09

New Medical Coverage Guideline.

11/15/10

Scheduled review. No change in position statement; references updated.

10/15/11

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

10/15/12

Scheduled review; no change in position statement. Revised description section and updated references.

10/15/13

Scheduled review; no change in position statement. Revised description section and program exceptions section. Updated references.

Date Printed: December 17, 2017: 04:17 PM