Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary  
The patient is a 51-year-old male with degenerative disc disease of the lumbar spine and post-
laminectomy syndrome. The patient has requested authorization and coverage for Total disc 
arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other 
than for decompression); single interspace, lumbar. The Health Insurer has denied this request and 
reported 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 
submitted documentation does not support the medical necessity of the requested services. The 
U.S. Food and Drug Administration (FDA) has expanded approval for the Prodisc L Total Disc 
Replacement to include treatment of up to two contiguous lumbar spinal levels from L3-S1 for 
skeletally mature patients with degenerative disc disease (DDD), who have experienced no pain 
relief after at least six months of non-surgical treatment. The affected vertebral disc must be no 
more than 25% out of the proper position consistent with grade 1 spondylolisthesis. However, 
FDA  exclusions  include  injections  at  the  implant  location  or  elsewhere  and  osteopenia  or 
osteoporosis with a T-score of less than -1.0. This patient is being treated for degenerative disc 
disease of the lumbar spine and post-laminectomy syndrome. The visit notes dated 1/13/23 indicate 
he presented with lower back and left leg pain that has been present intermittently since 2010. He 
underwent an L4-5 and L5-S1 microdiscectomy in 2010 and did well. However, the patients 
symptoms returned, and he underwent a revision in 2016. He reported constant, electric shock pain 
shooting down from his lower back into the bilateral legs, left worse than right. Bending, sitting, 
standing, and walking are listed in the visit notes as aggravating factors causing a low quality of 
life. The patient reported weakness in his lower extremities and difficulty walking for greater than 
a quarter mile. His pain is generally 7/10 at rest and increases with activity. The patients physical 
examination revealed mild lumbosacral paraspinal tenderness/spasms, straight leg raise positive 
on the left, and left tibialis anterior and extensor hallucis longus strength of 3+/5. The visit notes 
dated 1/13/23 document that the patient received an epidural steroid injection at the requested 
surgical level of L5-S1. A review of the record revealed there is no documentation of a dual energy 
x-ray  absorptiometry  (DEXA)  scan  or  other  testing  performed  to  rule  out  osteopenia  or 
osteoporosis. Additionally, scoliosis is not discussed, and lumbar spine x-rays are not provided 
with a noted Cobb angle. Formica and colleagues concluded, The optimal surgical indication is 
crucial to achieve excellent clinical and radiological outcomes. The authors also noted that there 
should be documentation of a coronal deformity of 15 degrees or less Cobb angle. Based on the 
available documentation, the patients Cobb angle is not reported to support an indication for the 
requested surgical intervention. There are limited large-scale, long-term references showing the 
safety and efficacy of the requested surgery in this patients clinical setting. Therefore, the 
requested total  disc arthroplasty (artificial disc), anterior approach, including  discectomy to 
prepare interspace (other than for decompression); single interspace, lumbar, is not medically 
necessary to treat the enrollee's medical condition.