Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the Vertiflex Superion Interspinous device. 
 
You asked the Plan to pre-approve the Vertiflex Superion Interspinous device. You say that this device is 
medically necessary for this patient. The Plan denied your request. The Plan says the Vertiflex device is 
contraindicated in patients in the setting of lumbar stenosis. The enrollee has multi-level spine disease from 
T12-L5. The Vertiflext Superion Interspinous Spacer device is not indicated in this enrollee given multi-level 
disease of more than 2 levels as seen on MRI. Placement of Vertiflex at L3-4 and L4-5 will not address the 
disease at the other levels. 
 
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 
device. Our reviewer says that the requested device is not considered medically reasonable and necessary in 
this case. Our physician reviewer found that this 50-year-old male was being treated for spinal stenosis of the 
lumbar region with neurogenic claudication. He presented with low back pain that does not radiate. The pain is 
aching, dull, and pressure. He reports the onset of pain was gradual over time. The pain is constant, made 
worse with bending, walking, and all activity. The pain is rated at 8/10 at its worst and 4/10 at its best. He 
smokes off and on. The exam reveals positive facet loading.  
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.  
 
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 at 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 imaging evidence of minimal listhesis of L4 on L5 and 
L5-S1, with no discussion of spinal instability on flexion/extension films. Weight is 251 pounds, height is 72 
inches, and body mass index is 34kg/m2. There is no discussion of scoliosis of the lumbar spine, and 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 patient. There is no compelling rationale presented or extenuating 
circumstances noted to support the medical necessity of this request as an exception. Therefore, the request for 
Vertiflex Superion interspinous device at L3-4 and L4-5 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 device have not been met. Therefore, we 
decided that the Plan does not have to pre-approve the Vertiflex Superion Interspinous device.