Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve an insertion of interlaminar/interspinous process 
stabilization/distraction device, without open decompression or fusion, including image guidance when 
performed, lumbar; single level (22869, 22870, C1821). 
 
You asked the Plan to pre-approve the Vertiflex Procedure. You say that the requested procedure is considered 
medically reasonable and necessary when all criteria has been met. Per the enrollee's treating physician, the 
enrollee meets the medical necessity outlined in the criteria. The Plan denied your request. The Plan says 
unproven and not medically necessary procedures are not covered by Medicare due to insufficient evidence of 
efficacy. 
 
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 the enrollee was being treated for spinal stenosis of the lumbar region with 
neurogenic claudication. He presented with back pain with radiation to the bilateral lower extremities with a lot 
of weakness in the legs. He has had pain for months. The exam reveals decreased range of motion of the 
lumbar spine with tenderness to palpation of the bilateral iliolumbar ligaments. Reflexes are 1+ at the bilateral 
patella and Achilles. Gait is antalgic. 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 indications include implantation of the Superion device 
at one or two adjacent lumbar levels in enrollees 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 of 
L3-4 and L4-5 levels.) FDA contraindications include spinal instability, scoliosis, obesity, and osteoporosis, 
and have not been adequately addressed in the medical records. There is no discussion indicating that a DEXA 
scan has demonstrated the lack of significant osteoporosis in this enrollee. There is no compelling rationale 
presented or extenuating circumstances noted to support the medical necessity of this request as an exception. 
Therefore, the requested Vertiflex Superion interspinous spacer at the L3-4 and L4-5 levels, in this case, 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 an insertion of interlaminar/interspinous process stabilization/distraction device, 
without open decompression or fusion, including image guidance when performed, lumbar; single level 
(22869, 22870, C1821).