Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the Vertiflex Superion procedure. 
 
You asked the Plan to pre-approve the Vertiflex Superion procedure. You say that the Vertiflex Superion 
procedure is medically necessary. The Plan denied your request. The Plan says the Vertiflex Superion 
procedure is unproven and not medically necessary due to insufficient evidence of efficacy. More studies are 
needed to show Vertiflex is safe and effective. 
 
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 Vertiflex Superion procedure. Our 
reviewer says that the requested Vertiflex Superion procedure is not considered medically reasonable and 
necessary. Our physician reviewer found the enrollee was being treated for spinal stenosis of the lumbar region 
with neurogenic claudication. The enrollee presented with lumbar spine pain with radiation towards both hips that is significantly worse when standing and walking. The exam reveals decreased range of motion of the 
lumbar spine with tenderness to palpation over the right iliolumbar ligament. Strength, sensation, and reflexes 
are intact. However, current evidence based medical guidelines 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 
enrollees medical condition. The U.S. Food and Drug Administration (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 L2-3 and L3-4.) FDA contraindications include spinal instability, scoliosis, obesity, and 
osteoporosis, and have not been adequately addressed in the medical records. There is no discussion of spinal 
instability on flexion/extension films. There is approximately 26 degrees convex rightward lumbar curvature. 
There is no discussion indicating that a bone density (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. Therefore, the requested Vertiflex Superion 
interspinous spacer at L2-3 and L3-4, in this case, 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 the Vertiflex Superion procedure have not been met. Therefore, we decided that 
the Plan does not have to pre-approve the Vertiflex Superion procedure.