Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer  
The patient is a 30-year-old male with a history of low back pain and lumbar disc degeneration. 
Conservative treatment had included physical therapy, acupuncture, epidural injection, and trigger 
point injection. The patient has requested authorization and coverage for lumbar disc replacement 
inpatient surgery. The Health Insurer has denied this request and reported that the requested 
services are not medically necessary for the treatment of this patient. This denial is the subject of 
this appeal and determination.  The physician reviewer found  that the U.S. Food and Drug 
Administration (FDA) approval for the ProDisc-L total disc replacement states that approval 
expands the indications for use of the ProDisc-L to include treatment of up to two consecutive 
lumbar spinal sections (levels) from L3-S1. Indications for this device include: patients who are 
skeletally mature with no spinal growth remaining; have a condition in which pain is caused by 
wear-and-tear on a spinal disc (degenerative disc disease or DDD) at one or two consecutive levels 
in the lumbar spine from L3-S1; no more than 25% of the affected vertebral disc that has slipped 
forward out of the proper position (grade 1 spondylolisthesis); and have no relief from pain after 
at least six months of non-surgical treatment. FDA exclusions include infection at the implant 
location or elsewhere; osteopenia or osteoporosis with a T-score (bone density measurement) less 
than -1.0; narrowing of the lumbar bones that puts pressure on the spinal cord and nerves (spinal 
stenosis);  allergy  or  sensitivity  to  the  implant  materials  (cobalt,  chromium,  molybdenum, 
polyethylene, titanium); compression syndromes due to herniated disc; stress fracture in the lumbar 
spine; affected vertebral endplate that is smaller than 34.5 mm when measured form the middle of 
the disc to the side of the disc and/or 27 mm when measured from the front of the disc to the back 
of the disc; damage to the affected disc due to current or past damage; and spondylolisthesis that 
is greater than Grade 1. Formica and colleagues noted, The optimal surgical indication is crucial 
to achieve excellent clinical and radiological outcomes. According to the literature and to our 
experience, we underline the importance of a coronal deformity less than 15 degree Cobb angle 
and a Roussouly type 1 or 2 as the profile of the most well-suited patient for total disc replacement. 
Our long-term results confirm the existing evidence about efficacy and safety of  total disc 
replacement as a reliable option, in optimal surgery indication, to treat degenerative disc disease. 
Yue and colleagues noted, Long-term evidence supports lumbar total disc replacement as safe. 
Nie and colleagues performed a meta-analysis to evaluate whether a beneficial clinical effect of 
the total disc replacement over lumbar fusion for the treatment of patients with degenerative disc 
disease. The authors noted, In a long-term of follow-up (2 years), total disc replacement shows a 
significant superiority for the treatment of lumbar degenerative disc disease compared with 
fusion. In this case, the patient presented with low back pain that radiates to his gluteal area. He 
occasionally also has posterior thigh tightness. The pain is increased with prolonged sitting. His 
pain is quite positional. He is able to decrease the pain with walking or standing. However, he 
reports working on the computer is difficult due to the pain. Examination revealed lumbar full 
range of motion. There is intact strength and sensation. However, detailed documentation is not 
evident regarding lumbar spine x-rays that corroborate that there is no instability of the lumbar 
spine, or significant scoliosis. Additionally, there is no discussion of a DEXA scan having been 
performed to evaluate for osteopenia or osteoporosis. These are FDA exclusions for the requested 
procedure. Therefore, the requested lumbar disc replacement inpatient surgery is not medically 
necessary for the treatment of this patient.