Appeal type: Surgery
Decision: Unfavorable

We decided that the Plandoes not haveto pre-approvean interspinous decompression spacer procedure for the enrollee.You asked the Planto pre-approvethe procedure. You say that this is medically necessary.The Plandenied your request. The Plansaysthe current medical literature does not support this treatment.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 thecase file and apply the relevant Medicare rules to determine if the Plan was correct in denying the request to pre-approve the procedure. Our reviewer says that the requested services are not considered medically reasonable and necessary in this case. Ourphysician reviewer found the enrollee presents with complaints of constant low back pain radiating to the right lower extremity to the foot. Functional limitations are noted in activities of daily living. Clinical exam findings have documented motor and sensory deficits generally consistent with imaging evidence of L4/5 right disc herniation with moderate spinal canal stenosis, right lateral recess effacement and nerve root compromise, and L5/S1 mild central canal stenosis. She has reportedly failed to achieve adequate improvement with long-term conservative treatment. Under consideration is a request for the Vertiflex procedure at 2 levels. 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 spinal stenosis at the L4/5 leveland mild spinal stenosis at the L5/S1 level which would not meet FDA indications for 2-level procedure. FDA contraindications include obesity and osteoporosis, and have not been adequately addressed in the medical records. There is no documentation of theenrollee's height, weight or body mass index. There is no discussion indicating that a DEXA scan has demonstrated no osteoporosis in this post-menopausal 71-year-old female. Additionally, the safety and effectiveness of the Superion Interspinous Spacer has not been studied in patients with acute denervation secondary to radiculopathy. 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 procedure have not beenmet.Therefore, we decided that the Plandoes not haveto pre-approvean interspinous decompression spacer procedure for the enrollee.