Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve a Vertiflex device. 
 
You asked the Plan to pre-approve a Vertiflex device. You say that the requested Vertiflex device is medically 
necessary. The Plan denied your request. The Plan says the requested Vertiflex device 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 a Vertiflex device. Our reviewer says 
that the requested Vertiflex device is not medically necessary. Our physician reviewer found this enrollee 
presents with complaints of grade 3-9/10 low back pain radiating down the left lower extremity to the shin. 
Pain is poorly controlled and interferes with activities of daily living. The 2/11/20 lumbar spine MRI 
radiologist impression documents very severe spinal stenosis at L4/5, severe spinal stenosis at L3/4, and severe 
right and moderate to severe left L4 neuroforaminal narrowing. There is radiographic evidence of grade 1 
spondylolisthesis at L3/4 and trace retrolisthesis at L4/5 with no evidence of spinal segmental instability on 
flexion and extension x-rays. There is also radiographic evidence of mild to moderate dextroscoliosis centered 
at L2/3. She has reportedly failed long-term conservative treatment. Under consideration is a request for 
Vertiflex interspinous 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. FDA indications include implantation of the Superion device at one or two 
adjacent lumbar levels in patients with moderate spinal stenosis in whom operative treatment is indicated at no 
more than two levels, from L1 to L5. This enrollee has severe L3/4 and L4/5 spinal stenosis that would not 
 
 
fully meet FDA indications. FDA contraindications include scoliosis and osteoporosis, and have not been 
adequately addressed in the medical records. There is documentation of mild to moderate dextroscoliosis with 
no documentation that the Cobb angle is less than 10 degrees. There is no discussion indicating that a DEXA 
scan has demonstrated no osteoporosis in this post-menopausal 77-year-old female. Superion indirect lumbar 
decompression would not be considered the standard of care for the enrollee's medical condition and would be 
considered investigational. 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 a Vertiflex device have not been met. Therefore, we decided that the Plan does 
not have to pre-approve a Vertiflex device.