Musculoskeletal Services #: 00.01.66a
The purpose of this communication is to provide notice regarding updated coverage position for minimally invasive fusion/stabilization of the sacroiliac joint using a titanium triangular implant.
A number of percutaneous or minimally invasive stabilization/fusion/fixation devices have been cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process; although the iFuse® Implant System (SI Bone) is the only triangular implant with an FDA approval for Sacroiliac joint (SIJ) pain treatment.
For individuals with SIJ pain who receive SIJ stabilization/fusion/fixation with a triangular implant, the evidence includes 2 non-blinded randomized controlled trials (RCTs) of minimally invasive fusion and 2 case series with more than 85% follow-up at 2 to 3 years. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Both RCTs reported superior short-term results for fusion, however, a preferable design for assessing pain outcomes would be independent, blinded assessment of outcomes or, when feasible, a sham-controlled trial. Longer term follow-up from these RCTs has indicated that the results obtained at 6 months persist to 2 years. An additional cohort study and case series, with sample sizes ranging from 45 to 149 individuals and low dropout rates (<15%), have also shown reductions in pain and disability at 2 years. One small case series showed outcomes that persisted to 5 years. The cohort studies and case series are consistent with the durability of treatment benefit. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and cumulative revision rate at 4 years of 3.54%. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Furthermore, comprehensive clinical input & feedback supports that stabilization/fusion/fixation of the sacroiliac joint using percutaneous and minimally invasive techniques for carefully selected patients, as outlined in statements from the North American Spine Society (NASS), provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice.
Minimally invasive stabilization/fusion/fixation of the sacroiliac joint using a titanium triangular implant, (i.e., iFuse® Implant System (SI Bone)), is considered medically necessary and, therefore, covered when ALL of the following criteria have been met:
Issued on - 05/14/2018