Appeal type: Surgery
Decision: Unfavorable

We decided that the Plan does not have to pre-approve a Vertiflex device.

You asked the Plan to pre-approve a Vertiflex device. You say that the requested Vertiflex device is medically necessary. The Plan denied your request. The Plan says the requested Vertiflex device is not medically necessary.

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 a Vertiflex device. Our reviewer says that the requested Vertiflex device is not medically necessary. Our physician reviewer found the enrollee was being treated for spinal stenosis, lumbar region, with neurogenic claudication. She cites back pain that is moderate-severe and is worsening. It is described as dull, numbness, throbbing, and cramping. Symptoms are aggravated by lifting, walking, and stooping. Symptoms are relieved by ice, pain medications/drugs, rest and sitting. Exam reveals she presents in a wheelchair. Weight is 106 pounds, height of 5 foot 3.5 inches, and BMI of 18.48 kg/m2. There is tenderness of the lumbar and lumbosacral spine. There is severe pain on motion with restrictions noted at severe on flexion and lateral bending. 

However, 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 multiple degrees of spinal stenosis, many not at FDA indicated levels of "moderate" spinal stenosis (including the planned level of implantation at L4/5 level.) FDA contraindications include spinal instability, scoliosis, obesity, and osteoporosis, and which have not been adequately addressed in the medical records. Detailed documentation is also not evident regarding discussion of spinal instability on flexion/extension films. There is imaging evidence of thoracolumbar curvature noted, with no documentation of the Cobb angle. There is no discussion indicating that a DEXA scan has demonstrated the lack of significant osteoporosis in this enrollee. There is no compelling rationale presented or extenuating circumstances noted to support the medical necessity of this request as an exception to guidelines. Therefore, the request for Vertiflex device at L4/5 level is not medically reasonable or necessary. 

We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of a Vertiflex device have not been met. Therefore, we decided that the Plan does not have to pre-approve a Vertiflex device.