Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve insertion of an interbody biomechanical device (Coflex 
device) (22853) with osteotomy of spine, arthrodesis and posterior non-segmental instrumentation (22214, 
22630, 22840). 
 
You asked the Plan to pre-approve insertion of a Coflex device. You say that these services are medically 
necessary. The Plan denied your request. The Plan says the requested device and related services do not meet 
Medicare criteria for medical necessity. 
 
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 insertion of a Coflex 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 Food and Drug Administration (FDA), 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. The Coflex is 
intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. 
Interlaminar stabilization is performed after decompression of stenosis at the affected level(s). 
Contraindications for the use include: prior fusion or decompressive laminectomy at any index lumbar level; 
radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or 
tumor (e.g., compression fracture); severe facet hypertrophy that requires extensive bone removal which would 
cause instability; grade II or greater spondylolisthesis; isthmic spondylolisthesis or spondylolysis (pars 
fracture); degenerative lumbar scoliosis (Cobb angle of great than 25 degrees); osteoporosis; back or leg pain 
of unknown etiology; axial back pain only, with no leg, buttock or groin pain; morbid obesity defined as a body 
mass index greater than 40; active or chronic infection, systemic or local; known allergy to titanium alloys or 
MRI contrast agents; and cauda equina syndrome defined as neural compression causing neurogenic bowel of 
bladder dysfunction. There is relatively limited evidence to guide the use of surgery for the management of 
lumbar spinal stenosis, as there are no published placebo-controlled trials investigating the effects of surgery 
for this condition. Most of the evidence supporting the use of surgery comes from randomized trials comparing 
surgery with non-surgical interventions, with conflicting conclusions. The addition of fusion to decompression 
is not only more costly, but also leads to more intraoperative blood loss and longer operation time, and fails to 
result in superior clinical outcomes when compared with decompression alone. Operation using interspinous 
spacer devices is quicker, and results in less blood loss and shorter hospital length of stay than fusion. These 
devices, however, do not provide better outcomes than conventional decompression, and are associated with 
higher reoperation rates. 
 
This 69-year-old female was being treated for radiculopathy of the lumbar spine. She presented with persistent 
low back pain that is now at 10/10. She wishes to pursue the surgery. The exam reveals strength, sensation, and 
reflexes are intact. Range of motion is full with no pain.     
 
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 this enrollees 
medical condition as discussed above. 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 have not been adequately addressed in the medical 
records. There is no discussion of spinal instability on flexion/extension films. Height is 62 inches, weight is 
212 pounds, and body mass index is 38.8 kg/m2. 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 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 requested Coflex device with osteotomy of spine, arthrodesis and posterior non-segmental instrumentation, 
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 insertion of a Coflex device have not been met. Therefore, we decided that the 
Plan does not have to pre-approve insertion of an interbody biomechanical device (Coflex device) (22853) with 
osteotomy of spine, arthrodesis and posterior non-segmental instrumentation (22214, 22630, 22840).