BlueCross and BlueShield of Montana Medical Policy/Codes
Isolated Facet Joint Fusion
Chapter: Surgery: Procedures
Current Effective Date: November 26, 2013
Original Effective Date: November 26, 2013
Publish Date: August 26, 2013
Description

A facet joint fusion is a procedure that fuses facet joints together to provide stabilization to the spinal column and reduce pain.  It can be performed in conjunction with a posterior lumbar fusion.  However, an isolated facet joint fusion has been proposed as a treatment option for individuals with facet pain that does not respond to conservative treatment.  Various types of materials can be used during facet fusion procedures; autograft, allograft, or prepared allograft bone dowel (e.g., TruFUSE®, [minSURG™ Corp., Clearwater, FL.]; NuFix [Nutech Medical, Birmingham, AL]). The U.S. Food and Drug Administration (FDA) classifies the allograft bone dowels as biologics. (1)

TruFUSE® (minSURG Corp., Clearwater, Florida) is a posterior fusion option for C2-S1 vertebrae.  The procedure can be performed open, minimally invasively through a cylindrical tissue retractor, or entirely percutaneously.  TruFUSE uses specially shaped, small pieces of human bone, called allograft, to stabilize the spine.  A compaction reamer is used to make a tunnel in the facet joint.  The allograft is then inserted to secure the facet joints.  By stopping the joint from moving, TruFUSE provides support that allows for fusion. (2)

NuFix™ (NuFix, Inc., Birmingham, Alabama) is another facet stabilization and fusion device constructed of allograft bone.  It is placed in the facet joint after an appropriate drill hole has been made. This effectively “locks” the facet joint preventing flexion, extension and rotation. This procedure can be done both open and percutaneously with fluoroscopic assistance. (3)

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 isolated facet joint fusion, with or without instrumentation, that includes prepared allograft bone graft dowel, whether used exclusively as stand-alone stabilization devices or as part of another procedure, is considered experimental, investigational and unproven, including but not limited to, e.g., TruFUSE® [any level], NuFix™ [any level]).

Rationale

In 2002, Park et al. conducted a two-year follow-up study on 99 patients to assess the safety, efficacy, and complication rate associated with instrumented facet fusion of the lumbar and lumbosacral spine.  Eighty-two patients underwent a one-level fusion for spondylolisthesis and accompanying canal stenosis (n=44) or disc herniation (n-38); fourteen patients underwent two-level fusion for either double instances of the above indications (n=7) or concurrent stenosis at the adjacent level (n=10).  The overall success rate of fusion was 96%; success rate by fusion type were 99% in one-level fusion fusions and 88% in two-level fusions.  Patients with concurrent stenosis had a success rate of 80%.  The study is limited by lack of control group for comparison to non-surgical options. (4)

In 2010, Gavaskar conducted a prospective, non-randomized study of 30 patients with low-grade spondylolisthesis of lumbar and lumbosacral spine who underwent facet fusion using two cortical screws and bone grafts.  Visual analogue scale and Oswestry disability assessment were used to measure outcomes which revealed twenty-nine of the thirty patients with significant improvement at one-year follow-up.  The study is limited to short-term follow-up, subjective outcomes and lack of comparison to other treatment modalities. (5)

The American Association of Neurological Surgeons published a technical assessment of TruFuse in 2009.  They concluded that there is insufficient information to evaluate the safety and utility of this device or make recommendations regarding clinical usage. (6)

At their 2011 annual meeting, the American Academy of Pain Physicians (AAPM) presented a retrospective case series on minimally invasive facet fusion procedures, such as the Trufuse, for the treatment of facet mediated low back pain and instability due to Grade 1 spondylolisthesis. In this procedure, a cannula is used to guide a drill into lumbar facet joint. A tapered allograft of cortical bone is inserted and tamped to secure press fit with the allograft dowel using real time fluoroscopy to ensure successful placement. This mitigates the risk of foraminal trespass and dowel back out. The AAPM stated that literature about the Trufuse is sparse, however. A retrospective chart review was conducted. Eight adult patients underwent Trufuse. Post-op care included wearing of a lumbosacral orthosis for 3 months. The primary clinical outcome measures were the Oswestry Disability Index (ODI). A telephone interview was performed at 2 years follow-up, by an independent operator. ODI improved from 73% to 13% in 3 out of 8 patients who subsequently stopped their pain medications and were discharged. They were also compliant in wearing their brace. Five patients had no improvement in ODI and continued to require analgesics. These 5 patients were not compliant with use of the lumbar brace. No patient demonstrated a deterioration in the ODI. Dowel dislodgement was identified on CT scanning, in those who failed treatment. The AAPM conclude that Trufuse is one of the minimally invasive techniques in spine surgery that may benefit a subset of patients with lumbar facet mediated pain; treatment failure may be due to dowel dislodgement and lack of compliance with brace utilization. (7)

Summary

Clinical evidence is limited to small, uncontrolled trials with lack of blinding or long-term follow-up.  Randomized, controlled trials comparing these allograft materials to standardized autograft materials are needed to determine long-term efficacy and impact on health outcomes.  Therefore, isolated facet joint fusion remains experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes
84.84, 721.3, 721.42, 724.2, 738.4, 756.11, 756.12
ICD-10 Codes

M47.26 - M47.898, M47.16 - M47.18,  M54.5 - M54.5, M43.00 - M43.19, Q76.2, Q76.2

Procedural Codes: 0219T, 0220T, 0221T, 0222T
References
  1. Food and Drug Administration – Vaccines, Blood & Biologics. Available at http://www.fda.gov (accessed - 2011 May 11).
  2. TruFuse Facet Fusion.  ©miniSURG™ Corp.  Clearwater, Florida:  TruFUSE® Procedure. Available at http://www.trufuse.com . (accessed – December 2012).
  3. NuFix Precision Machined Allograft Antimigration Dowel. Birmingham, Alabama. Available at http://www.NuFix.org . (accessed - 2011 May 11).
  4. Park, Y., Kim, J., et al.  Facet fusion in the lumbosacral spine: A 2-year follow-up study.  Neurosurgery (2002) 51: 88-96.
  5. Gibson, J.N., and G. Waddell.  Surgery for degenerative lumbar spondylosis:  Updated Cochrane Review.  Spine (2005) 30(20): 2312-20
  6. American Association of Neurologic Surgeons. Technical Assessment of Tru-Fuse. (2009 – December).  Available at http://www.aans.org (accessed – December 2012).
  7. Trangco-Evans RA, Bejjani FJ, et al. TruFuse Facet Fusion Outcome: A Retrospective Case Series. American Academy of Pain Physicians (AAPP), Presented at the 2011 AAPM Annual Meeting. Available at < www.painmed.org> (accessed December 2012).
History
August 2013  New 2013 BCBSMT medical policy.  Isolated facet joint fusion, with or without instrumentation, that includes prepared allograft bone graft dowel, whether used exclusively as stand-alone stabilization devices or as part of another procedure, is considered experimental, investigational and unproven, including but not limited to, e.g., TruFUSE® [any level], NuFix™ [any level]). 
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Isolated Facet Joint Fusion