Medical Policies - Surgery


Isolated Facet Joint Fusion

Number:SUR712.032

Effective Date:10-15-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

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/or unproven. Examples include but are not limited to, TruFUSE® (any level), and NuFix™ (any level).

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. 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)

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 Medicine (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 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/or unproven.

2015 Update

A search of peer reviewed literature was conducted through March 2015. This medical policy has been updated with searches of the MEDLINE database. (8, 9) This update failed to identify any additional information that would change the coverage position of this medical policy.

2017 Update

A search of peer reviewed literature through July 18, 2017 identified no additional clinical trial publications that would prompt reconsideration of the coverage statement which remains unchanged.

Contract:

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.

Coding:

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.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0219T, 0220T, 0221T, 0222T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. U. S. Food and Drug Administration – Vaccines, Blood & Biologics. Available at <http://www.fda.gov> (accessed July 18, 2017).

2. TruFuse Facet Fusion. ©miniSURG™ Corp. Clearwater, Florida: TruFUSE® Procedure. Available at <http://www.minisurg.com>. (accessed July 18, 2017).

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 PMID 12182439.

5. Gavaskar, A., Achimuthu, R. Transfacetal fusion for low-grade degenerative spondylolisthesis of the lumbar spine: results of a prospective single center study. J Spinal Disord Tech. 2010 May; 23(3):162-5. PMID 20072033.

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 Medicine (AAPM), Presented at the 2011 AAPM Annual Meeting. Available at < www.painmed.org> (accessed July 18, 2017).

8. Cook, D.J., Yeager, M.S., et al. Lumbar Intrafacet Bone Dowel Fixation. Neurosurgery, 2015 Apr; 76(4):470-8. PMID: 25621985.

9. Pirris, S. M., Nottmeier, E.W. et al. Radiographic fusion rate after implantation of facet bone dowels. Spine J. 2014 Sep 1; 14(9):2102-11. PMID24448193.

Policy History:

DateReason
10/15/2017 Document updated with literature review. Coverage unchanged.
7/15/2016 Reviewed. No changes.
4/15/2015 Document updated with literature review. Coverage unchanged.
5/15/2013 Document updated with literature review. Coverage was changed to: 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]). Title changed from Minimally Invasive Percutaneous Facet Joint Fusion (TruFUSE). The entire Description and Rationale were revised.
1/1/2010 Document number changed. CPT/HCPCS code(s) updated.
1/15/2009 New medical document. Minimally invasive percutaneous joint fusion (i.e., TruFUSE®) is considered experimental, investigational and unproven when performed as a stand-alone inpatient procedure or as an outpatient procedure.

Archived Document(s):

Title:Effective Date:End Date:
Isolated Facet Joint Fusion07-01-202108-14-2022
Isolated Facet Joint Fusion01-15-202106-30-2021
Isolated Facet Joint Fusion02-15-201901-14-2021
Isolated Facet Joint Fusion10-15-201702-14-2019
Isolated Facet Joint Fusion07-15-201610-14-2017
Isolated Facet Joint Fusion04-15-201507-14-2016
Isolated Facet Joint Fusion05-15-201304-14-2015
Minimally Invasive Percutaneous Facet Joint Fusion (TruFUSE)01-01-201005-14-2013
Minimally Invasive Percutaneous Facet Joint Fusion (TruFUSE)01-15-200912-31-2009
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