MEDICAL POLICY

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APPENDIX
HISTORY

Facet Arthroplasty

Number 7.01.120

Effective Date September 23, 2014

Revision Date(s) 09/08/14; 09/09/13; 09/11/12, 09/13/11; 09/14/10

Replaces N/A

Policy

Total facet arthroplasty is considered investigational.

Related Policies

7.01.87

Artificial Intervertebral Disc: Lumbar Spine

7.01.107

Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)

7.01.130

Axial Lumbosacral Interbody Fusion

7.01.555

Facet Joint Denervation

Policy Guidelines

Coding

CPT

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

Definition of Terms

Facet arthroplasty - the implantation of a spinal prosthesis to restore posterior element structure and function, as an adjunct to neural decompression.

Facet arthrosis - chronic degenerative disease affecting the joints in the spine.

Spinal Stenosis - narrowing of the spinal column, resulting in pressure on the spinal cord.

Spondylolisthesis - a vertebra in the lower part of the spine slips out of the proper position onto the bone below it.

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 Phase III trial. The Phase 3 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 currently available in Europe. Premia Spine acquired Impliant in 2011.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

N/A

Rationale

This policy was developed in 2009 and is reviewed no less than annually and revised as needed based on a literature search using the MEDLINE database. The, most recent literature search was performed through June 3, 2014, with a focus on clinical trials.

Clinical Trials

A search of ClinicalTrials.gov in June 2014 found the following:

  • NCT00401518 this is a Phase III U.S. multicenter randomized trial of the ACADIA™ Facet Replacement System. (1) 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. Study completion with 24-month follow-up is expected in October 2014. (Identified from the EMBASE database was a conference proceeding of interim results in 100 patients).
  • NCT00405691 – A prospective, multicenter clinical study to assess the Impliant TOPS™ system, 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. No results are posted.
  • NCT00418197 – this multicenter IDE trial of the Total Facet Arthroplasty System® (TFAS®) was discontinued due to financial reasons according to reports from the FDA. (2) (Facet Solutions acquired Archus Orthopedics and all of their assets in November 2009). Two of 10 TFAS procedures performed at the study authors’ institution had stem fracture after total facet replacement.
  • NCT01933607 – As of June 2014, an industry-sponsored postmarketing study of the TOPS™ system is not yet open for recruitment. There is an estimated enrollment of 10 subjects in this single-arm study. Study completion is expected December 2016.

Summary

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.

U.S. Preventative Services Task Force Recommendations

Facet arthroplasty is not a preventive service.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

References

  1. 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.
  2. 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.

Coding

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

Type of Service

Surgery

 

Place of Service

Inpatient

 

Appendix

N/A

History

Date

Reason

09/15/09

Add to Surgery Section - New Policy

09/14/10

Replace Policy - Policy updated with literature search through May 2010; the policy statement remains unchanged.

09/15/11

Replace Policy – Policy updated with literature review through May 2011; policy statement unchanged.

02/27/12

Related Policies updated; 7.01.130 added.

09/11/12

Replace policy. Policy updated with literature review through May 2012; reference numbers 1 and 2 added; policy statement unchanged.

9/27/12

Update Related Policies- 7.01.130 added.

07/25/13

Update Related Policies. Change title to 7.01.107.

09/27/13

Replace policy. Policy title updated, the word “Total” is deleted. A literature review through June, 2013 did not prompt additions to references. Policy statement unchanged.

03/11/14

Coding Update. Codes 84.84 and 84.85 were removed per ICD-10 mapping project; these codes are not utilized for adjudication of policy.

05/20/14

Update Related Policies. Remove 7.01.116 as it was deleted, and replace with 7.01.555.

09/23/14

Annual Review. Added definition of terms to the policy guidelines section. A literature review through June 3, 2014 did not prompt the addition of new references. Policy statement unchanged.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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