Appeal type: Surgery
Decision: Unfavorable

We decided that the Plan does not have to pre-approve the Superion interspinous spacer for the enrollee.
You asked the Plan to pre-approve the spacer. You say that this is medically necessary. The Plan denied your request. The Plan says a review of the current medical literature indicates that this service is considered 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 the spacer. Our reviewer says that the requested services are not considered medically reasonable and necessary in this case. Our physician reviewer found the enrollee presents with complaints of bilateral lumbosacral pain. Pain increased with standing and walking. Clinical exam findings have documented pain with flexion and positive straight leg raise. There is imaging evidence of multilevel degenerative changes most pronounced within the lower lumbar spine spanning L3/4 to the L5/S1 levels, with severe neuroforaminal stenosis noted at L4/5. She has reportedly failed long-term conservative treatment, including multiple epidural steroid injections. Under consideration is a request for the Superion (Vertiflex) interspinous spacer procedure at L3/4 and L4/5. 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 in patients with moderate spinal stenosis in whom operative treatment is indicated at no more than two levels, from L1 to L5. This enrollee has moderate right and mild to moderate left L3/4 neuroforaminal stenosis and moderate to severe left and severe right L4/5 neuroforaminal stenosis. The severity of the stenosis at L4/5 would not meet FDA indications. FDA contraindications include spinal instability, scoliosis, and osteoporosis, and have not been adequately addressed in the medical records. There is a grade 1 anterolisthesis of L4 on L5 with no x-ray report showing no spinal instability on flexion/extension films. There is imaging evidence of levocurvature of the lumbar spine with no documentation of the Cobb angle. There is no discussion indicating that a DEXA scan has demonstrated no osteoporosis in this post-menopausal 73-year-old female. 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 the spacer have not been met. Therefore, we decided that the Plan does not have to pre-approve the Superion interspinous spacer for the enrollee.