Appeal type: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve a VertiFlex device. 
 
You asked the Plan to pre-approve a VertiFlex device. You say that the requested device is medically 
necessary. You say that the enrollee has no evidence of remarkable scoliosis at the level in question, nor does 
the enrollee have documented evidence of severe osteoporosis. The Plan denied your request. The Plan says the 
FDA indications for the VertiFlex state that it is contraindicated for patients with scoliosis. 
 
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 a VertiFlex device. Our reviewer says 
that the requested item is not considered medically reasonable and necessary in this case. Our physician 
reviewer found This enrollee presents with complaints of persistent low back and leg pain. Signs/symptoms are 
reported consistent with intermittent neurogenic claudication. Pain and symptoms interfere with quality of life 
and activities of daily living. There is imaging evidence of severe central canal stenosis at L1/2 and L4/5, 
moderate central canal stenosis at L2/3, mild to moderate central canal stenosis at L3/4, severe right 
neuroforaminal stenosis at L3/4, severe left neuroforaminal stenosis at L5/S1, and mild to moderate 
neuroforaminal stenosis at L4/5 and L5/S1. There is radiographic evidence of apex left lumbar scoliosis of 15 
degrees. He has reportedly failed conservative treatment, including physical therapy, medications, spinal 
injections, and activity modification. Under consideration is a request for Vertiflex (Superion) interspinous 
spacer for a diagnosis of L4/5 spinal stenosis. 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 enrollee's medical condition as discussed above. A current clinical trial is underway with no 
results posted. There is no discussion relative to why this enrollee would not be indicated for standard 
decompression surgery. FDA indications include implantation of the Superion device at one or two adjacent 
lumbar levels in patients in whom operative treatment is indicated at no more than two levels, from L1 to L5. 
This enrollee has severe canal and/or neuroforaminal stenosis noted at the L1/2, L3/4, L4/5, and L5/S1 levels. 
FDA contraindications include scoliosis (Cobb angle greater than 10 degrees). This enrollee has evidence of a 
levoscoliosis of 15 degrees centered at L3. The Vertiflex Superion Indirect Decompression System would not 
be considered the standard of care for the enrollee's medical condition. Therefore, this request does not meet 
Medicare criteria as medically reasonable and necessary for treatment of this enrollee's medical condition. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of a VertiFlex device have not been met. Therefore, we decided that the Plan does 
not have to pre-approve a VertiFlex device.