BlueCross and BlueShield of Montana Medical Policy/Codes
Total Facet Arthroplasty
Chapter: Surgery: Procedures
Current Effective Date: October 25, 2013
Original Effective Date: June 07, 2010
Publish Date: October 25, 2013
Revised Dates: August 22, 2012; September 4, 2013
Description

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.

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.  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.

No facet arthroplasty device has been approved by the U.S. Food and Drug Administration (FDA) at this time.

The Total Facet Arthroplasty System® (TFAS®, Archus Orthopedics, Inc., Redmond, Washington) is currently being evaluated as part of an ongoing FDA-approved investigational device exemption (IDE) protocol.  Facet Solutions®, Inc., (Hopkinton, MA) acquired Archus Orthopedics and all of their assets in November 2009.  Facet Solutions is also developing the ACADIA™ Facet Replacement System (AFRS®), also in clinical trials.  Another implant design, the Total Posterior-element System (TOPS™, Impliant Ltd., Israel), is currently in development.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers facet arthroplasty, by any method, including but not limited to the Total Facet Arthroplasty System, whether performed inpatient or outpatient,  or as part of another procedure, experimental, investigational and unproven.

Rationale

A peer-reviewed literature search was performed through December 2010.

In 2009, Phillips et al. reported a manufacturer-sponsored study on TFAS that assessed the kinematics of implanted and adjacent lumbar segments in nine human lumbar spines (L1 to sacrum).  Specimens were tested as follows: intact, after L3 laminectomy with L3-L4 facectomy, after L3-L4 pedicle screw fixation, and after L3-L4 TFAS implantation.  The author’s conclusions were that the “TFAS restored range and quality of motion at the operated segment to intact values and restored near-normal motion at the adjacent segments”.

Two Phase III clinical trials, both sponsored by the device developers were found as follows:

The ACADIA™ Facet Replacement System (AFRS®, NCT00401518) is an actively recruiting U.S. multicenter randomized controlled trial with a primary objective to evaluate the overall success rate in patients with spinal stenosis when compared to a posterior spinal fusion. The study began in 2006, is expected to enroll around 300 subjects, and has an estimated completion of 2013.  Specific inclusion criteria are patients between 21 and 85 years of age with lateral, lateral recess and/or central canal stenosis, disc height measuring ≥ 4 mm at the operative level, with persistent leg, thigh and/or buttock symptoms, including pain, numbness, burning, or tingling with a minimum leg pain score of 40-mm as measured by the Visual Analogue Scale (VAS) refractory to at least six months of conservative treatment, candidate for a decompression with full facetectomy at the operative level, candidate for a posterior lumbar fusion.  Study participants will be randomly assigned in a 2:1 ratio into treatment with the investigational artificial facet replacement device (TFAS®) or with standard posterior instrumented fusion.

The Total Facet Arthroplasty System® (TFAS®, NCT00418197) is a randomized controlled trial listed as ongoing but not currently recruiting. The study began in 2005, is expected to enroll around 450 subjects, and has no estimated date of completion. It is designed for patients with moderate to severe lumbar spinal stenosis requiring neural decompression with facetectomy at L3-L4 or L4-L5, Grade I degenerative spondylolisthesis with objective evidence of neurologic impairment, and degenerative disease of the facets, with or without instability.   Specific inclusion criteria are patients between 50 and 85 years of age with degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5, with persistent leg symptoms, including pain, numbness, burning, or tingling that are refractory to at least six months of conservative treatment, no greater than Grade I degenerative spondylolisthesis at the index level, and no more than three levels of degenerative lumbar spinal stenosis requiring decompression.  Study participants will be randomly assigned in a 2:1 ratio into treatment with the investigational artificial facet replacement device (TFAS®) or with standard posterior instrumented fusion.

Pending publication of these trials and subsequent FDA approvals, available evidence is insufficient to evaluate the effect of facet arthroplasty on health outcomes. Therefore, facet arthroplasty is considered experimental, investigational and unproven.

ICD-9 Codes
84.84, 84.85 
ICD-10 Codes
0RRA0J4, 0SR00J4, 0SR30J4
Procedural Codes: 0202T
References
  1. Phillips, F.M., Tzermiadianos, M.N., 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.
  2. Total Facet Arthroplasty System® (TFAS® Clinical Trial). Available at <http://www.clinicaltrials.gov> (accessed January 31, 2011).
  3. A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis. The Evaluation of the ACADIA™ Facet Replacement System. Available at http://www.clinicaltrials.gov (accessed January 31, 2011).
  4. Facet Arthroplasty.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 July) Surgery 7.01.120.
History
August 2012  Policy updated with literature review through May 2012; reference numbers 1 and 2 added; policy statement unchanged.
October 2013 Policy formatting and language revised.  Policy statement changed.  Title changed from "Total Facet Arthroplasty" to "Facet Arthroplasty".
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Total Facet Arthroplasty