Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2
A 49-year-old female has requested authorization and coverage for 22857 [total disc 
arthroplasty (artificial disc), two-day inpatient stay]. The Health Insurer has 
denied this request and reported that the requested services are investigational for
the treatment of the enrollees medical condition. The physician reviewer found that
the U.S. Food and Drug Administration (FDA) approves the use of ProDisc-L total disc
replacement for 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; patients who have a condition in which pain is 
caused by wear-and-tear on a spinal disc, such as degenerative disc disease, at one 
or two consecutive levels in the lumbar spine from L3-S1; patients with no more than
25% of the affected vertebral disc having slipped forward out of the proper position
(grade 1 spondylolisthesis); and patients who have no relief from pain after at 
least six months of non-surgical treatment. The FDA notes that contraindications 
include infection at the implant location or elsewhere; osteopenia or osteoporosis 
with a T-score bone density measurement of the less than -1.0; narrowing of the 
lumbar bones that puts pressure on the spinal cord and nerves; allergy or 
sensitivity to the implant materials such as cobalt, chromium, molybdenum, 
polyethylene, titanium; compression syndromes due to herniated disc; stress fracture
in the lumbar spine; an 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; current or past damage 
to the affected disc; and spondylolisthesis that is greater than Grade1. 
Buttner-Janz and colleagues report, With respect to safety, there was good 
agreement in the literature to exclude patients with osteopenia/osteoporosis or 
fracture. Risk of injury to vascular structures due to the anterior approach was 
often addressed by excluding patients with previous abdominal surgery in the area of
disc pathology or increased age. The literature was very consistent on the primary 
indication for total disc replacement being painful disc degeneration unresponsive 
to at least 6 months of nonoperative care. Literature investigating the impact of 
previous spine surgery was mixed; however, prior surgery was not necessarily a  contra-indication, provided the patient otherwise met selection criteria. The 
literature was mixed on setting a minimum preoperative disc height as a selection 
criterion. There were no publications investigating whether some patients are 
better/worse candidates for specific total disc replacement designs. Based on the 
literature a proposal for patient selection criteria is offered. In a follow-up at 
the five-year mark of 236 patients who underwent either ProDisc-L total disc 
replacement or fusions, Zigler and colleagues noted that the total disc replacement 
group had significantly better improvement on some scales, and while total disc 
replacement patients avoid the stiffness of fusion and are more satisfied than 
fusion patients, both fusion and total disc replacement were reasonable surgical 
options in this specific patient population. In this case, the patient presented to 
her provider on 7/14/21 with back and primarily left lower extremity pain for 
several years. The patient rated her pain at seven out of ten and reported having 
tried and failed multiple epidural injections and therapy without improvement. The 
patient reported having to change her professional activities as an occupational 
therapist to accommodate her pain. On examination, the patient had mild limited 
range of motion of her lumbar spine. A review of MRI scans from 5/28/21 reported  at
the L4-5 level severe disk height loss and mild narrowing of the exiting neural 
foramen, without evidence of clear instability. X-rays showed L4-5 degenerative disc
disease with coronal angulation, and mid-lumber mild scoliosis of approximately ten 
degrees at the L1 and L2 levels. Computed tomography (CT) of the lumbar spine on 
7/23/21 reported the following at L4-5: severe disc height loss which is worse on 
the left with associated endplate sclerosis and lateral spurring, an eccentric disc 
bulge to the left without high-grade spinal canal stenosis, mild bilateral facet 
arthropathy along with lateral spurring and bulging results in moderate-to-severe 
left and moderate right neural foraminal stenosis. The records noted multiple levels
of pathology, including thoracolumbar levoscoliosis of 21 degrees from T12-L1 
through L3-4. There are multiple additional levels of degenerative disc 
abnormalities. The submitted records did not include detailed documentation 
regarding the epidural steroid injections that had been tried and failed including 
the dates, the levels, and the respective benefit with those injections. However, 
regardless of the respective benefit, or lack thereof, with lumber epidural steroid 
injections, there are multiple plausible alternative pain generators. In this 
clinical setting, there is a lack of published, large-scale, long-term peer-reviewed
medical literature showing that the requested service is an effective and safe 
treatment for the noted pathology. Therefore, 22857 [total disc arthroplasty 
(artificial disc), two-day inpatient stay] is not likely to be more beneficial for 
treatment of the patient's condition than any available standard therapy.