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.
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]).
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)
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.
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.