Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve a laminectomy with Coflex placement.  
 
You asked the Plan to pre-approve this service. You say that you are requesting a reconsideration of the Plan's 
denial. The Plan denied your request. The Plan says the requested service is not medically necessary.  
 
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 this service. Our reviewer says that the 
requested service is not considered medically reasonable and necessary in this case. Our physician reviewer 
found that you were being treated for spinal stenosis of the lumbar region with neurogenic claudication. You 
presented noting two months ago that you worsened again and have very classic claudication pain with a L4 
pattern with minimal standing and walking. Your pain is constant in the back and right leg and more 
intermittent in the left leg.   
 
The exam reveals lower lumbar facet tenderness and a mildly positive Patricks test. Your strength is intact and 
your reflexes are absent in the quadriceps and ankles jerk bilaterally. There is some foot numbness from 
neuropathy noted. 
 
However, current evidence based medical guidelines 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 your medical 
condition. Food and Drug Association (FDA) indications include the Coflex device for use in one or two-level 
lumbar stenosis from L1- L5 in skeletally mature patients with at least moderate impairment in function, who 
experience relief in flexion from their symptoms of leg/buttocks/ groin pain, with or without back pain, and 
who have undergone at least six months of non-operative treatment. FDA contraindications include prior fusion 
or decompressive laminectomy, radiographically compromised vertebral bodies, severe facet hypertrophy, 
spinal instability, scoliosis, obesity, and osteoporosis, and which have not been adequately addressed in the 
medical records. There is imaging evidence of grade 1 anterolisthesis with no discussion of spinal instability on 
flexion/extension films. There is no documentation of your height, weight, or body mass index. There is no 
discussion of scoliosis of the lumbar spine with no documentation of the Cobb angle. There is no discussion 
indicating that a dual x-ray absorptiometry (DEXA) scan has demonstrated the lack of significant osteoporosis. 
There is no compelling rationale presented or extenuating circumstances noted to support the medical necessity 
of this request as an exception to guidelines. Therefore, the requested Coflex placement at L3-4 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 this service have not been met. Therefore, we decided that the Plan does not 
have to pre-approve a laminectomy with Coflex placement.