Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the implantable intraspinous process distraction device 
(Vertiflex device), glucose monitoring, collection of capillary blood, spinal x-ray, cefazolin sodium injection, 
fentanyl citrate injection, and vancomycin hydrogen chloride injection 
 
You asked the Plan to pre-approve the implantable intraspinous process distraction device (Vertiflex device), 
glucose monitoring, collection of capillary blood, spinal x-ray, cefazolin sodium injection, fentanyl citrate 
injection, and vancomycin hydrogen chloride injection. You say that at the time of authorization, the enrollee 
had Medicare Part A and B and authorization was not required. The appellant says that after authorization and 
before the surgery on March 17, 2023, the enrollee changed their health plan.  The Plan denied your request. 
The Plan says the Vertiflex device is not medically necessary. The Plan says this service is considered 
experimental and investigational. The Plan says authorization for the surgery was not obtained.  
 
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 implantable intraspinous process 
distraction device (Vertiflex device), glucose monitoring, collection of capillary blood, spinal x-ray, cefazolin 
sodium injection, fentanyl citrate injection, and vancomycin hydrogen chloride injection. Our reviewer says 
that the requested services are not medically necessary. Our physician reviewer found the enrollee was being 
treated for spinal stenosis of the lumbar region with neurogenic claudication. 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. The x-rays showed anterior spondylolisthesis of L2 on L3 without 
evidence of motion in flexion or extension. The procedure was provided at two levels; however, these were not 
at adjacent levels. The Food and Drug Administration (FDA) supports implantation at two levels if they are 
adjacent. This is not evident in this case. Please note, the records show that the requested ancillary services are 
related to a non-covered service. 
 
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 implantable intraspinous process distraction device (Vertiflex device), 
glucose monitoring, collection of capillary blood, spinal x-ray, cefazolin sodium injection, fentanyl citrate 
injection, and vancomycin hydrogen chloride injection have not been met. Therefore, we decided that the Plan 
does not have to pre-approve the implantable intraspinous process distraction device (Vertiflex device), glucose 
monitoring, collection of capillary blood, spinal x-ray, cefazolin sodium injection, fentanyl citrate injection, 
and vancomycin hydrogen chloride injection