Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the Vertiflex procedure. 
 
You asked the Plan to pre-approve the Vertiflex procedure. You say that this is medically reasonable and 
necessary. The Plan denied your request. The Plan says the requested Vertiflex procedure 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 the Vertiflex procedure. Our reviewer 
says that the requested items/services are not considered medically reasonable and necessary in this case. Our 
physician reviewer found that the enrollee is a 75-year-old female being treated for spinal stenosis of the 
lumbar region with neurogenic claudication. She presented with sharp and achy pain that is rated at 7/10 and is 
constant. The pain radiates down the right leg stopping at the knee. The pain worsens with standing/walking 
and improves with medications. Height is 62, weight is 143, and body mass index is 26.15 kg/m2. The exam 
reveals multiple taught bands palpated in the lumbar spine with radiation towards the spine and hips. Straight 
leg raise is positive in the bilateral lower extremities with radiation to extremity.  
 
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 and L4.) 
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. Height is 62, weight is 143, and body mass index is 26.15 kg/m2. There no discussion of scoliosis of the 
lumbar spine, with no documentation of the Cobb angle. There is no discussion indicating that a dual-energy X-
ray absorptiometry 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 and L4 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 procedure have not been met. Therefore, we decided that the Plan 
does not have to pre-approve the Vertiflex procedure.