Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary  
The patient is a 52-year-old male who presented to his provider on 2/23/23. The patient reported 
lumbar spine pain that radiated to the left hip/buttock. The patient has requested authorization and 
coverage for total disc arthroplasty. The Health Insurer has denied this request and reported that 
the requested service is 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  submitted 
documentation does not support the medical necessity of the requested service. In this case, the 
patient has intervertebral disc disorders with radiculopathy of the lumbar region. He presented with 
lumbar spine pain radiating to the left hip/buttock, described as sharp and throbbing with numbness 
and tingling to the anterior thigh, which increases with sitting and prolonged standing. The records 
note gait disturbance off and on. An examination revealed intact strength and sensation. The U.S. 
Food and Drug Administration (FDA) approves the use of ProDisc-L total disc replacement for 
spinal arthroplasty in skeletally mature patients with degenerative disc disease at one or two 
consecutive levels from L3 to S1. The FDA further notes that the patient should be skeletally 
mature with no spinal growth remaining, have a condition in which pain is caused by wear-and-
tear on a spinal disc at one or two consecutive levels in the lumbar spine from L3 to S1, have no 
more than grade 1 spondylolisthesis at the involved level(s), and have failed at least six months of 
conservative treatment. The FDA notes that contraindications include active systemic or site 
infection, osteopenia or osteoporosis, bony lumbar spinal stenosis, allergy or sensitivity to implant 
materials, isolated radicular compression syndromes especially due to disc herniation, and stress 
fracture in the lumbar spine. In this case, the patient presents with degenerative disc disease at the 
requested L5-S1 level without instability and noted moderate disc space narrowing. He has tried 
and failed extensive conservative care measures. However, the submitted records do not document 
any DEXA scans to corroborate that the lumbar spine is free from osteopenia or osteoporosis with 
a T-score (bone density measurement) of less than -1.0. Formica and colleagues report, 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 arthroplasty. Our long-term results confirm the existing evidence 
about efficacy and safety of total disc arthroplasty as a reliable option, in optimal surgery 
indication, to treat degenerative disc disease. In this case, lumbar x-rays do not document the 
coronal deformity and/or lack thereof with a Cobb angle of less than 15 degrees. Yue and 
colleagues note, Long-term evidence supports lumbar total disc replacement as safe. The next-
generation activL Artificial Disc is more effective at preserving range of motion than first-
generation lumbar total disc arthroplastys (ProDisc-L and Charite) and offers a higher safety 
profile. Other primary and secondary outcomes are similar between disc designs. Despite the use 
of total disc replacement being a viable option for lumbar degenerative disc disease, in this clinical 
setting,  specific surgical requirements are not  met.  Therefore, total  disc arthroplasty  is  not 
medically necessary for the treatment of this patient.