MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Facet Arthroplasty

Number 7.01.120

Effective Date September 27, 2013

Revision Date(s) 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)

7.01.116

Facet Joint Denervation

7.01.130

Axial Lumbosacral Interbody Fusion

Policy Guidelines

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

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.

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.

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.

Benefit Application

N/A

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:

  • 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.

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

ICD-10-CM (effective 10/01/14)

 

Investigational for all diagnoses

ICD-10-PCS (effective 10/01/14)

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

HCPCS

   

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.


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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