Appeal type: Surgery
Decision: Unfavorable

We decided that the Plan does not have to pre-approve the Vertiflex Superion indirect decompression system
for the enrollee.
You asked the Plan to pre-approve the system. You say that this is medically necessary. The Plan denied your
request. The Plan says the plan does not cover treatment for Medicare-approved studies.
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 system. 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 grade 1-2/10 low back pain with right calf pain at night. Prior
symptoms of severe right lower extremity pain had significantly resolved following a recent epidural steroid
injection. Clinical exam findings have documented motor and sensory deficits consistent with imaging
evidence of L4/5 disc degenerative with disc extrusion and facet arthropathy causing severe right
neuroforaminal stenosis. Additionally, there is moderate neuroforaminal stenosis at L1/2 and L2/3, and mild
neuroforaminal stenosis at L3/4. There is reported radiographic evidence of degenerative scoliosis, multilevel
neuroforaminal narrowing, and L4 on L5 anterolisthesis. She has reportedly failed conservative treatment,
including physical therapy, home exercise program, medications, chiropractic and epidural steroid injection.
Under consideration is a request for the Vertiflex Superion Indirect Decompression System at L4/5. 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 for moderate spinal stenosis in patients in whom operative treatment is indicated at no more than two
levels, from L1 to L5. These indications have not been met. There is imaging evidence of severe
neuroforaminal stenosis at L4/5 and mild neuroforaminal stenosis at L1/2 and L2/3. FDA contraindications
include scoliosis (Cobb angle greater than 10 degrees) and osteoporosis, and have not been adequately
addressed in the medical records. There is reported radiographic evidence of degenerative scoliosis of the
lumbar spine with no documentation of the Cobb angle. There is no discussion indicating that a DEXA scan
has demonstrated no osteoporosis in this post-menopausal 72-year-old female. 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 system have not been met. Therefore, we decided that the Plan does not
have to pre-approve the Vertiflex Superion indirect decompression system for the enrollee.