Appeal type: Practitioner Services
Decision: Unfavorable

We decided that the Plan does not have to pre-approve a Vertiflex Superion procedure.
You asked the Plan to pre-approve Insertion of Interlaminar/Interspinous Process Stabilization/Distraction Device (22869) and Insertion of Interlaminar/Interspinous Process Stabilization/Distraction Device (22870). You say that the enrollee has failed conservative treatment and will benefit more from this procedure. The Plan denied your request. The Plan says this procedure is experimental and investigational.
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically necessary are not covered. We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to determine if the Plan was correct in denying the request to pre-approve Insertion of Interlaminar/Interspinous Process Stabilization/Distraction Device (22869) and Insertion of Interlaminar/Interspinous Process Stabilization/Distraction Device (22870). Our reviewer says that the requested items/services are not considered medically reasonable and necessary in this case. Our physician reviewer found that there is relatively limited evidence to guide the use of surgery for the management of lumbar spinal stenosis, as there are no published placebo-controlled trials investigating the effects of surgery for this condition. Most of the evidence supporting the use of surgery comes from randomized trials comparing surgery with non-surgical interventions, with conflicting conclusions. The addition of fusion to decompression is not only costlier, but also leads to more intraoperative blood loss and longer operation time, and fails to result in superior clinical outcomes when compared with decompression alone. Operation using interspinous spacer devices is quicker, and results in less blood loss and shorter hospital length of stay than fusion. These devices, however, do not provide better outcomes than conventional decompression, and are associated with higher reoperation rates. This enrollee has reportedly failed conservative treatment, including physical therapy, medications, spinal injections, and activity modification. Current evidence based medical guideline and peer reviewed literature do not fully support the spinal decompression device procedure over the 'gold standard' of lumbar laminectomy. There is a lack of large volume, long-term peer-reviewed outcome studies to support the use of this device for this enrollee's medical condition as discussed above. FDA indications include implantation of the Superion
device at one or two adjacent lumbar levels for moderate spinal stenosis in patients in whom operative treatment is indicated at no more than two levels, from L1 to L5. These indications have not been met. Superion indirect lumbar decompression would not be considered the standard of care for the enrollee's medical condition. Therefore, this request does not meet Medicare criteria as medically reasonable and necessary for treatment of this enrollee's medical condition. We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of Insertion of Interlaminar/Interspinous Process Stabilization/Distraction Device (22869) and Insertion of Interlaminar/Interspinous Process Stabilization/Distraction Device (22870) have not been met. Therefore, we decided that the Plan does not have to pre-approve a Vertiflex Superion procedure.