Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve placement of the Coflex device. 
 
You asked the Plan to pre-approve placement of the Coflex device. You say that this is medically reasonable 
and necessary for the enrollee's condition. The Plan denied your request. The Plan says this device is 
considered experimental/investigational. 
 
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 placement of the Coflex device. Our 
reviewer says that the requested items/services are not considered medically reasonable and necessary in this 
case. Our physician reviewer found that the enrollee is a 78-year-old female who was being treated for spinal 
stenosis, lumbar region with neurogenic claudication; spondylosis without myelopathy/radiculopathy lumbar 
region; spondylolisthesis lumbar region. She presented with pain involving the low back and bilateral lower 
extremities. Over the last year, she reports severe low back and leg pain with activity and decreased activity 
tolerance. She describes flexed forward posture with ambulation now requiring the assistance of a cane. She 
notes associated symptoms of numbness, tingling and abnormal gait. An exam reveals an antalgic gait with the assistance of a cane. There is low back tenderness. There is decreased sensation in the bilateral L4 and L5. 
Straight leg raise is positive bilaterally. 
 
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. Food and Drug Administration (FDA) indications include the Coflex device is 
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 6 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 and have not 
been adequately addressed in the medical records.) There is imaging evidence of 10mm of anterolisthesis of L4 
relative to L5 and 8mm of anterolisthesis of L5 relative to S1; on flexion L4-L5 anterolisthesis increases to 
14mm, evidencing borderline instability.) Height is 5 feet, weight 175 pounds 0.7 ounces, and body mass index 
34.19 kg/m2. There is imaging evidence of moderate rightward 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 patient. 
 
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 request for Coflex device at L3-4 and L4-5 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 placement of the Coflex device have not been met. Therefore, we decided that 
the Plan does not have to pre-approve placement of the Coflex device.