Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the Vertiflex Superion interspinous spacer. 
 
You asked the Plan to pre-approve the Vertiflex Superion interspinous spacer. You say that the Vertiflex 
Superion interspinous spacer is medically necessary and received Food and Drug Administration (FDA) 
approval in 2015, based on a randomized controlled trial. The Plan denied your request. The Plan says there are 
not enough studies on Vertiflex Superion interspinous spacer to show it is safe and effective. Therefore, it is 
not considered standard of care. 
 
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 interspinous 
spacer. Our reviewer says that the requested Vertiflex Superion interspinous spacer is not considered medically 
reasonable and necessary. Our physician reviewer found that this enrollee was being treated for spinal stenosis of the lumbar region with neurogenic claudication. The enrollee presented via telehealth with low back pain 
that is rated at 7/10 currently. The pain is constant and is worst in the evenings. The pain is aching, dull, numb, 
shooting, squeezing, stabbing/sharp, tingling/pins and needles, and tiring/exhausting, and the enrollee feels it 
has increased. There is significant back/buttock/leg pain. 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 enrollees medical condition. The FDA indications include implantation 
of the Vertiflex 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 of L3-4 and L4-5). 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 imaging evidence of dextrocurvature 
centered at L2-3 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. 
Therefore, the requested Vertiflex Superion interspinous spacer at L3-4 and L4-5, 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 interspinous spacer have not been met. Therefore, we 
decided that the Plan does not have to pre-approve the Vertiflex Superion interspinous spacer.