Coverage of Conditions and Treatments (Coverage Decisions)

Use this lookup tool to determine coverage decisions, or if prior authorization is needed for the treatment or condition. Note: For Self-insured employer claims, you must contact the employer or their claims administrator.

List also available in PDF format.

Archived Coverage Decisions.

See Treatment Guidelines and Resources for additional information.

Coverage Decision

Total posterior spine system (TOPS^TM System) is a non-covered service for workers’ compensation claims. The TOPS^TM System is considered experimental
and investigational.

Background information

The TOPS^TM System is a dynamic spine stabilization device (also referred to as a motion-preserving spinal implant) that is inserted into the lumbar spine via pedicle screws to treat spondylolisthesis/stenosis, stabilizing the spine following lumbar decompression without fusion. The TOPS^TM System was approved by the FDA for marketing only for Grade I spondylolisthesis, which is a non-covered indication for lumbar fusion in L&I’s workers’ compensation system.

The evidence of effectiveness and safety of the TOPS^TM System is very limited, including a preliminary report of a randomized controlled trial (RCT), a planned interim analysis of the RCT, and a few small case series. The quality of the evidence is poor. Long-term data on effectiveness and safety are lacking.

The preliminary report published by Coric et al., 2023 (Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis, J Neurosurg Spine. 38 (1):115-125) is the key publication of the IDE trial in support of this device. Review of the study demonstrates significant flaws of the IDE trial. The paper fails to show the disposition of all enrolled patients and the number of patients included in the primary outcome assessment, which is critical information for assessing the quality and validity of the trial. Nevertheless, the trial appears to have very high non-compliance rates or/and dropout rates. The primary and secondary outcomes were assessed with Per-Protocol rather than Intention-To-Treat (ITT) analysis, which resulted in losing the randomization benefits, and being prone to selection bias.

The objective of the IDE trial was to assess superiority and non-inferiority of TOPS^TM System vs. fusion. However, this primary endpoint (superiority/non-2 inferiority) is not tested in the publication. In other words, the results reported in this paper do not demonstrate that the TOPS^TM System is better or worse than fusion for treatment of lumbar spinal spondylolisthesis. Furthermore, the authors of the study have significant financial conflict of interest, adding to potential bias to the study.

In general, the department or self-insurer will not authorize nor pay for treatment measures of a controversial, obsolete, investigational or experimental nature (WAC 296-20-03002). Under certain conditions, the department may determine that such treatment is appropriate. Any coverage for investigational treatment would be considered per WAC 296-20-02850.