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) and an insertion of interlaminar/interspinous process 
stabilization/distraction device, without open decompression or fusion, including image guidance when 
performed, lumbar; second level (22870). 
 
You asked the Plan to pre-approve the Vertiflex procedure. You say that the posterior interspinous 
decompression spacer procedure is needed to treat lumbar spinal stenosis with neurogenic claudication. 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 noting temporary relief (from the epidural injection done on February 
11, 2023, for about two days. The exam was limited and notes he appears in no acute distress. 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. 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 levels of implantation of L3-4 and L4-5.) 
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. There is no discussion of scoliosis of the lumbar spine, along with no documentation of the Cobb angle. 
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 L3-4 and L4-5, 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) and an insertion of interlaminar/interspinous process stabilization/distraction device, without open 
decompression or fusion, including image guidance when performed, lumbar; second level (22870).