Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve placement of the Superion interspinous spacer device. 
 
You asked the Plan to pre-approve the Superion procedure. You say that this is a medically indicated procedure 
which is FDA-approved. The Plan denied your request. The Plan says there is not sufficient evidence that this 
procedure is safe and effective. 
 
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 Superion procedure. Our reviewer 
says that the requested items/services are not considered medically reasonable and necessary in this case. Our 
physician reviewer found According to the Food and Drug Administration (FDA), the VertiFlex Superion 
Interspinous Spacer is indicated to treat skeletally mature patients suffering from pain, numbness, and/or 
cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate degenerative 
lumbar spinal stenosis. The Superion Interspinous Spacer is indicated for those patients with impaired physical 
function who experience relief in flexion from symptoms of leg/buttock/groin pain, with or without back pain, 
who have undergone at least 6 months of non-operative treatment. The Superion Interspinous Spacer may be implanted 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 68-year-old female was being treated for spinal stenosis, lumbar region with neurogenic claudication. She 
presented with right hip pain. The exam reveals decreased sensation to light touch in the right L3, L4, and L5 
dermatomes. There is tenderness to palpation of the lumbosacral spine noted. The range of motion is decreased 
with pain. Straight leg raise is positive on the right.  
 
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. FDA contraindications include spinal instability, scoliosis, obesity, and osteoporosis, and have not 
been adequately addressed in the medical records. There is imaging evidence of grade 1 anterolisthesis of L4 
on L5, with no discussion of spinal instability on flexion/extension films. There is no discussion indicating that 
a bone density 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 to guidelines. Therefore, the request for Vertiflex Superion interspinous device at L3-L4 and L4-L5 
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 Superion procedure have not been met. Therefore, we decided that the Plan 
does not have to pre-approve placement of the Superion interspinous spacer device.