Appeal type: Practitioner Services
Decision: Unfavorable

We decided that the Plan does not have to pre-approve insertion of interlaminar/interspinous
stabilization/distraction 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 research has not found this service to be helpful.
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 device is not considered medically reasonable and necessary in this case. Our physician reviewer
found the enrollee presents with chronic low back pain radiating to the right lower extremity to the foot with
associated numbness and cramping. He reportedly sustained a fall in early August with increased pain.
Currently, pain is reported to be improving. Signs/symptoms are reported consistent with neurogenic
claudication. Clinical exam findings have not documented focal neurologic deficits. There is evidence of
conservative treatment to include activity modification with reduction in work hours. There is imaging
evidence of mild to moderate lateral recess and foraminal stenosis at L1/2 and L2/3, mild to moderate central
canal stenosis at L3/4 with moderate lateral recess and foraminal stenosis, and moderate central canal stenosis
and moderately severe lateral recess and foraminal stenosis at L4/5. Under consideration is a request for the
Vertiflex (Superion) device at L3/4 and 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. There is no discussion relative to why this
enrollee would not be indicated for standard decompression surgery. Additionally, FDA criteria have not been
met. There is no detailed evidence of 6-months of reasonable and/or comprehensive conservative treatment and
failure. There is no documentation that pain is relieved in flexion as pain is reportedly increased with bending
forward or sitting. There is multilevel spinal stenosis, up to moderate at the L1/2 through L4/5 levels. There is
imaging evidence of a levoscoliosis with no documentation that the Cobb angle is less than 10 degrees. There is
no discussion of osteoporosis screening in this enrollee on anticoagulant therapy. Therefore, this request for
insertion of an interlaminar/interspinous stabilization/distraction device (CPT codes 22869 and 22870) is not
reasonable and medically necessary for 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 insertion of interlaminar/interspinous stabilization/distraction device for the enrollee.