Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Vertiflex device insertion. 
 
You asked the Plan to pre-approve Vertiflex device insertion. You say that the patient has suffered from this 
condition for over 30 years and as failed 360 months of conservative approaches to treatment. The Plan denied 
your request. The Plan says this treatment is considered experimental/investigational. 
 
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 Vertiflex device insertion. Our reviewer 
says that the requested items/services are not considered medically reasonable and necessary in this case. Our 
physician reviewer found this 67-year-old male was being treated for spinal stenosis of the lumbar region with 
neurogenic claudication. He presented with ongoing mostly low back pain described as stabbing, burning, and 
aching that goes to the lower limbs. He tried a MILD procedure on March 3, 2022, with about 50% 
improvement. The pain has worsened to baseline. 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 as discussed above. 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 which have not been adequately addressed in the 
medical records. There is no discussion of spinal instability on flexion/extension films. The weight is 195 
pounds, height is 175.26 cm, and body mass index is 28.79 kg/m2. There is imaging evidence of mild to 
moderate lumbar levoscoliosis, 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. Overall, 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 Vertiflex device insertion have not been met. Therefore, we decided that the 
Plan does not have to pre-approve Vertiflex device insertion.