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 Vertifilex device. You say that you disagree with the denial and are 
requesting reconsideration for approval of this procedure as the enrollee wants it done as soon as possible. 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 a Vertifilex device. 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 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, with or 
without grade 1 spondylolisthesis, confirmed by x-ray. The enrollee presented with pain in the back at L3-4, 
L4-5, and L5-S1. The exam reveals moderate tenderness to palpation of the lower lumbar facets L4-5 and L5-
S1. SI joints are painful to palpation bilaterally. Straight leg raise was positive bilaterally. Strength is decreased 
in the bilateral lower extremities. Sensation is diminished in the bilateral distal lower extremities. 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. 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 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 a Vertifilex device 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).