Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 30-year-old female enrollee has requested authorization and coverage for cervical total disc replacement surgery and one day inpatient services. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees neck pain.   The physician reviewer found that the North American Spine Society evidence-based clinical guidelines state that cervical artificial disc replacement may be indicated for patients with radiculopathy related to single level degenerative disease, either herniated disc or spondylotic osteophyte, from C3-4 to C6-7 with or without neck pain that has been refractory to conservative treatment (Bono, et al). Cervical artificial disc replacement may also be indicated for single level degenerative disease from C3-4 to C6-7 with or without neck pain that is severe enough to warrant surgical intervention. Guidelines state that cervical artificial disc replacement is not indicated in symptomatic multilevel disease that would require multiple level artificial disc replacement. Davis and colleagues performed a prospective, randomized, controlled multicenter clinical trial with four-year follow-up to evaluate the safety and effectiveness of two-level total disc replacement with Mobi-C cervical artificial disc versus anterior cervical discectomy and fusion (ACDF). The four-year results from this study support total disc replacement as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at two contiguous cervical levels. Radcliff and colleagues completed an independent review of a prospective, randomized, controlled multicenter investigational device exemption clinical trial. Results supported the use of anterior cervical surgery for contiguous two-level pathology as safe and effective. The authors concluded that total disc replacement was superior to anterior cervical discectomy and fusion for the treatment of two-level contiguous pathology at five years. Thus, there is evidence based medical peer-reviewed literature supports the use of two-level contiguous cervical artificial disc replacement as an option over anterior cervical discectomy and fusion for the treatment of symptomatic degenerative disc disease. This patient presents with neck pain radiating into the right upper extremity with tingling and weakness. She has reportedly failed reasonable conservative treatment. There is clinical evidence of motor weakness and reflex change. Additionally, there is imaging evidence of multilevel disc protrusion and annular tears from C3-4 through C6-7 with minimal to mild central canal stenosis. However, given the significant degenerative findings at the C3-4 and C6-7 levels, a two-level total disc replacement would not be supported at the C4-5 and C5-6 levels. For this reason, the requested cervical total disc replacement at C4-5 and C5-6 is not likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy.  Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.