Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve insertion of interlaminar/interspinous process 
stabilization/distraction device, without open decompression or fusion, including image guidance when 
performed, lumbar; single level (22869). 
 
You asked the Plan to pre-approve a Interspinous Spacer. You say that the enrollee has suffered from 
neurogenic claudication due to lumbar spinal stenosis since the 1980's and for the past two years, it has greatly 
impacted the quality of his life. The provider strongly believes coverage should be provided under the 
enrollee's plan. The Plan denied your request. The Plan says based on the documentation, the Vertiflex device 
is not approved because the severe spinal stenosis does not meet the guidelines set forth by the Plan. 
 
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 Interspinous Spacer. Our reviewer 
says that the requested items/services are not considered medically reasonable and necessary in this case. Our 
physician reviewer found 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 level of implantation at L3/4 level.). 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. There 
is no discussion of scoliosis of the lumbar spine, 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 the L3/L4 
level, 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 a Interspinous Spacer have not been met. Therefore, we decided that the Plan 
does not have to pre-approve insertion of interlaminar/interspinous process stabilization/distraction device, 
without open decompression or fusion, including image guidance when performed, lumbar; single level 
(22869).