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MP 7.01.120 Facet Arthroplasty

Medical Policy    
Section
Surgery 
Original Policy Date
July 2009
Last Review Status/Date
Reviewed with literature search/7:2013
Issue
7:2013
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


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.

Background

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. If normal motion patterns are achieved by artificial joints in the spine, the risk of adjacent-level degeneration thought to be associated with fusion may be mitigated.

Regulatory Status

No facet arthroplasty devices have been approved by the U.S. Food and Drug Administration (FDA) at this time. The ACADIA™ Facet Replacement System (Facet Solutions, Hopkinton, MA) 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®, Archus Orthopedics) has been discontinued. (Facet Solutions acquired Archus Orthopedics and all of their assets in 2009. In 2011, Globus Medical acquired substantially all of the assets of Facet Solutions.) Another implant design, the Total Posterior-element System (TOPS™, Impliant Ltd., Israel), is in development and has restarted enrollment in a FDA-regulated Phase III trial in 2011 after design and manufacturing changes. Premia Spine acquired Impliant in 2011. 


Policy

Total facet arthropolasty is considered investigational. 


Policy Guidelines

A CPT Category III code specific to this procedure became effective July 1, 2009:

0202T: Posterior vertebral joint(s) arthroplasty (e.g., facet joint[s] replacement) including facetectomy, laminectomy, foraminotomy and vertebral column fixation, injection of bone cement, when performed, including fluoroscopy, single level, lumbar spine. 


Benefit Application
BlueCard/National Account Issues

No applicable information. 


Rationale

Searches of the MEDLINE database, most recently performed through June 4, 2013, identified a report indicating that the U.S. Food and Drug Administration (FDA)-regulated multicenter investigational device exemption (IDE) trial (NCT00418197) of the Total Facet Arthroplasty System® (TFAS®) was discontinued due to financial reasons. (1) (Facet Solutions acquired Archus Orthopedics and all of their assets in November 2009). Two out of 10 TFAS procedures performed at the authors’ institution had stem fracture after total facet replacement.

Identified from the EMBASE database was a conference proceeding of interim results in 100 patients from a Phase III U.S. multicenter randomized trial of the ACADIA™ Facet Replacement System (NCT00401518). (2) The study began in 2006, is expected to enroll around 300 subjects with lumbar spinal stenosis, and compares facet arthroplasty with the ACADIA™ system to posterior spinal fusion. Information posted on the online site ClinicalTrials.gov indicates that recruitment is ongoing. Study completion with 24-month follow-up is expected in October 2013.

A search of ClinicalTrials.gov in June 2013 showed the following trial:

  • A prospective, multicenter clinical study to assess the Impliant TOPS™ system (NCT00405691), This study is listed as completed as of May 2011. The study began in 2006 with an estimated enrollment of 450 subjects with back and leg pain resulting from moderate/severe lumbar spinal stenosis at a single vertebral level between L3 to L5.

Facet arthroplasty refers to the implantation of a spinal prosthesis to restore posterior element structure and function as an adjunct to neural decompression. In addition to the lack of evidence on clinical outcomes with facet arthroplasty, no device has received FDA approval. Therefore, facet arthroplasty is considered investigational.

Medicare National Coverage

There is no national coverage determination.

References:

  1. Palmer DK, Inceoglu S, Cheng WK. Stem fracture after total facet replacement in the lumbar spine: a report of two cases and review of the literature. Spine J 2011; 11(7):e15-9.
  2. Dryer RF, Regan JJ, Hartjen CA et al. Prospective US IDE trial: Interim results for the treatment of symptomatic lumbar spinal stenosis with facet replacement in 100 patients enrolled at 15 centers. Spine J 2010; 10(9 SUPPL 1):90S.

  

Codes

Number

Description

CPT 

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

ICD-9 Procedure 

84.84

Insertion or replacement of facet replacement device(s)

 

84.85

Revision of facet replacement device(s)

ICD-9 Diagnosis

 

Investigational for all diagnoses

ICD-10-CM (effective 10/1/14)    Investigational for all diagnoses
ICD-10-PCS (effective 10/1/14) 0RRA0J4 Replacement, thoracolumbar vertebral joint, open, synthetic substitute, facet
  0SR00J4 Replacement, lumbar vertebral joint, open, synthetic substitute, facet
   0SR30J4 Replacement, lumbosacral joint, open, synthetic substitute, facet

Index

Total facet arthroplasty
TFAS


Policy History

Date Action Reason
07/09/09 Add policy to Surgery section Policy created with literature search through May 2009; considered investigational
07/08/10 Replace policy Policy statement with literature search through May 2010; policy statement unchanged
7/14/11 Replace policy Policy updated with literature review through May 2011; policy statement unchanged
07/12/12 Replace policy Policy updated with literature review through May 2012; reference numbers 1 and 2 added; policy statement unchanged
7/11/13 Replace policy Policy updated with literature review through June 4, 2013; policy statement unchanged