Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve a Superion InterSpinous spacer device. 
 
You asked the Plan to pre-approve a Superion InterSpinous spacer device. You say that the appropriate 
treatment option currently available to the enrollee is the minimally invasive placement of a posterior 
interspinous process spacer. You say that the requested device/procedure is not experimental or investigational, 
based primarily on the substantial body of published clinical literature to support the safety, efficacy, and 
durability of the Vertiflex procedure. The Plan denied your request. The Plan says the use of this device is not 
supported for long term relief of back and leg pain. The Plan says that there are currently no clinical indications 
for this technology. 
 
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 Superion InterSpinous spacer device. 
Our reviewer says that a Superion InterSpinous spacer device is not considered medically reasonable and 
necessary in this case. Our physician reviewer found the enrollee was being treated for spinal stenosis of the 
lumbar region with neurogenic claudication. He presented with continued low back pain. The pain gets better 
when he leans over. 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-L4.) FDA contraindications include spinal instability, scoliosis, obesity, and osteoporosis, 
and have not been adequately addressed in the medical records. There is no discussion of spinal instability on 
flexion/extension films. The enrollee's height is 70 inches, weight is 221 pounds, and body mass index is 31.71 
kg/m2. There is no discussion of scoliosis or documentation of the (as applicable) Cobb angle. There is no 
discussion indicating that a dual energy X-ray absorptiometry (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. 
 
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 Superion InterSpinous spacer device have not been met. Therefore, we 
decided that the Plan does not have to pre-approve a Superion InterSpinous spacer device.