Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for L5-S1 total disc arthroplasty. Lumbar disc arthroplasty (LDA) remains a controversial surgical strategy for the treatment of low back pain related to isolated degenerative disc disease when compared with lumbar spinal fusion, generally perceived to be the gold standard surgical procedure. The American Association of Neurological Surgeons (AANS) state, There is still debate among the medical community about the efficacy of artificial lumbar disc surgery. In many of the pivotal trials, patients who had artificial discs implanted saw improvements in their back pain and a lowering of their disability after surgery, but the difference in improvement between the artificial disc and a standard fusion surgery was not considered meaningful. LDA is purported to possess several potential advantages over lumbar fusion surgery including preservation of motion at the treated segment, potential avoidance of adjacent segment disease, and preservation or improvement in spinal alignment. However, current medical literature includes both favorable and unfavorable data regarding the efficacy and safety of LDA. In a systematical review or 57 publications, Guntin and colleagues reported that while 39 of the publications reported favorable results, 30 of the articles were influenced by financial conflicts of interest, and that articles by authors with conflicts of interest were significantly more likely to demonstrate favorable outcomes. The authors concluded, Orthopedic surgeons should critically evaluate study outcomes with regard to potential conflicts before recommending LDA as a surgical option to their patients. In a meta-analysis of 14 randomized controlled trials (RCT), Bai and colleagues concluded that LDA was superior to lumbar fusion for the treatment of degenerative disc disease with improvements in Oswestry Disability Index (ODI) scores, Visual Analogue Scale (VAS) scores, short form (SF)-36 scores, patient satisfaction, overall success, and reoperation rates. In an updated systematic review and meta-analysis of seven RTCs, Li and colleagues concluded that LDA was superior to lumbar fusion in terms of improved clinical success, reduced pain, patients satisfaction, shortened hospital stay and operating time, and lessened complication rate. However, other systematic reviews and meta-analyses have failed to demonstrate the superiority of LDA to fusion, although finding it equivalent and a reasonable alternative. In a Cochrane review on the topic, Jacobs and colleagues, while suggesting caution in wide scale adoption of LDA, report that in the short-term, LDA is at least equivalent to fusion surgery. Mills and colleagues report that the use of LDA has decreased 82% from 2005 to 2017. Sun and colleagues note that indications for LDA include the absence of fact joint arthrosis confirmed by computed tomography (CT), and that exclusion criteria include moderate or worse facet joint arthritis. In this case, the records document that the patient has tried and failed meaningful nonsurgical strategies. While current medical literature supports the equivalence of LDA to fusion surgery in highly selected patients, a contraindication or exclusion for LDA is facet arthropathy. Given that the records in this case include an MRI documenting facet arthropathy at the index level, the requested service is not medically indicated. Therefore, L5-S1 total disc arthroplasty is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested service is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in neurological surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.