Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve an interspinous and/or interlaminar device for the 
enrollee. 
 
You asked the Plan to pre-approve the device. You say that this is medically necessary. The Plan denied your 
request. The Plan says medical studies have not proven that this device is helpful for treatment of the health 
problem. 
 
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 device. Our reviewer says that the 
requested services are not considered medically reasonable and necessary in this case. Our physician reviewer 
found the enrollee presents with persistent low back pain radiating into the right leg with signs/symptoms of 
neurogenic claudication. Functional limitations are noted in activities of daily living. Clinical exam findings 
have documented L4 and L5 myotomal weakness. There is imaging evidence of multilevel degenerative disc 
changes and facet arthropathy with multilevel degenerative listhesis, with L4/5 mild central canal narrowing, 
mild bilateral subarticular recess narrowing, and advanced bilateral facet arthropathy with 7 mm anterolisthesis. 
She has reportedly failed reasonable and/or comprehensive conservative treatment. Under consideration is a 
request for the Vertiflex procedure at the L4/5 level. 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 enrollee's medical condition as discussed above. FDA indications include 
implantation of the Superion device at one or two adjacent lumbar levels in patients with moderate spinal 
stenosis in whom operative treatment is indicated at no more than two levels, from L1 to L5. This enrollee has 
mild spinal stenosis at the L4/5 level that would not meet FDA indications. FDA contraindications include 
spinal instability and osteoporosis, and have not been adequately addressed in the medical records. There is no 
discussion indicating that a DEXA scan has demonstrated no osteoporosis in this post-menopausal 80-year-old 
female. There was a 4.5 mm anterolisthesis of L4 on L5 with no discussion of spinal instability on 
flexion/extension films. Superion indirect lumbar decompression would not be considered the standard of care 
for the enrollee's medical condition. Therefore, this request does not meet Medicare criteria as medically 
reasonable and necessary for treatment of this enrollee's medical condition. 
 
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 device have not been met. Therefore, we decided that the Plan does not have 
to pre-approve an interspinous and/or interlaminar device for the enrollee.