This version of the policy will become effective on 06/15/2020, and communicates Company's continuing medical policy positions for Artificial Intervertebral Disc Insertion. Description section was updated.
The North American Spine Society (2019) issued coverage recommendations for lumbar artificial disc replacement. The following recommendation was made:
Lumbar Artificial Disc Replacement is indicated for patients with discogenic low back pain who meet ALL of the following criteria
Lumbar Disc Arthroplasty is NOT indicated in ANY of the following scenarios:
For individuals who have cervical radicular pain or myelopathy who receive 2-level AIDA of the cervical spine, the evidence includes randomized controlled trials. Therelevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. The Food and Drug Administration approval for the Prestige LP was based on superiority to 2-level ACDF in overall success at two years. The increase in overall success rates at two years has been maintained for those patients who have reached the 5- and 7-year follow-ups. At 2- and 4-year follow-ups, the first artificial cervical disc approved for two levels (Mobi-C) was found to be superior to ACDF for Neck Disability Index scores, Neck Disability Index success rates, reoperation rates, and overall success composite outcome. At five years, trial results were consistent with the continued superiority of 2-level AIDA for clinical outcomes and lower cumulative reoperation rates. Adjacent-segment degeneration with Mobi-C was found in a significantly lower percentage of patients compared with 2-level ACDF patients. Based on this evidence, it can be concluded that 2-level AIDA with either of these Food and Drug Administration-approved discs is at least as beneficial as the established alternative.
Lumbar Artificial Intervertebral Disc Insertion
Total disc replacement, using an artificial intervertebral disc designed for the lumbar spine, is proposed as an alternative to spinal fusion in patients with degenerative disc disease leading to disabling symptoms.
According to the AAOS, lumbar fusion surgery remains the gold standard for individuals with persistent lumbar spine pain refractory to conservative nonsurgical management. LADR has been proposed as an alternative surgical treatment to the various types of spinal fusion. It is theorized that LADR may have the potential to reduce adjacent level lumbar DDD and preserve ROM.
The current available published peer-reviewed literature does not clearly establish the clinical efficacy of artificial intervertebral disc replacements for a number of reasons. Much of the published data on artificial discs comes from case study reports, which are low in the hierarchy of evidence. The few completed randomized controlled trials of artificial disc devices were conducted as part of the FDA-required premarket approval process, using a noninferiority trial design and comparing a specific artificial intervertebral disc to a specific type of spinal fusion surgery. Presently, there are no randomized controlled trials that compare the various types of spinal fusion surgery or that compare spinal fusion surgery to conservative management alone.
In August 2007, CMS issued a NCD for LADR. CMS determined that the procedure was not reasonable and necessary for individuals over 60 years of age. For Medicare beneficiaries younger than 60, CMS decided to leave the determination up to local Medicare contractors.
In a 2009 health technology assessment, ECRI evaluated the safety and effectiveness of LADR for lumbar DDD. At the time, ECRI indicated that the evidence base was limited due to lack of blinding, long-term follow-up, and comparisons to relevant control groups. In fact, some studies compared LADR with outdated methods of spinal fusion. LADR devices have many labeled contraindications (e.g., osteopenia, osteoporosis, radicular compression syndrome), which indicates that only a select population would benefit from device implantation. This further limits the already small sample size of most LADR studies, which in turn, increases the difficulty in estimating the number of adverse events associated with device implantation.
In a 2013 Cochrane systematic review, Jacobs et al. evaluated the effect of LADR for chronic low back pain due to lumbar DDD compared with fusion or other treatment options. The authors noted that among the seven randomized controlled trials included within the systematic review, there was a high risk of bias due to sponsoring and the absence of any blinding. Of these seven studies, six compared LADR with fusion (n=1301). All studies used ODI and VAS scores as outcome measurements. The authors indicate that the differences in clinical improvement were not beyond generally accepted boundaries for clinical relevance. The prevention of ALD and/or facet joint degeneration was not properly assessed. Radiological results were poorly reported across the studies and the definition of failure was varied or unclear, especially with respect to device-related failures. Therefore, the authors concluded that the number of adverse events associated with LADR that may occur in the long-term has not yet been researched. They advised that the clinical community should be prudent before adopting LADR.
Questions remain regarding the biologic effects of wear and the response of the prosthesis to its environment, particularly in the relatively young population in which these lumbar artificial intervertebral disc devices may be used. In addition, the effect of artificial disc on the progression of adjacent level DDD, which takes years to develop, is unknown. Complications associated with LADR devices are emerging with longer-term follow-up. Several recent studies have suggested that the facet joint at the index level and the disc at the adjacent level may show aggravation of the degenerative process in a significant number of patients. Other studies describe late complications which may include vertebral body fractures, persistent pain, device migration and failure, numbness, and degenerative scoliosis. Studies indicate that the wear mechanisms on artificial discs may be similar to artificial hips and knees and that due to nearby vascular structures and scar tissue from the original surgery, retrieval of an artificial disc device can be difficult and dangerous. Especially in a relatively young and active patient population for which LADR is intended, these long-term health outcomes may become a clinically significant issue.
For individuals who have lumbar degenerative disc disease who receive a lumbar artificial intervertebral disc, the evidence includes randomized controlled trials with 5-year outcomes and case series with longer term outcomes. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Five-year outcomes for the ProDisc-L randomized controlled trial have provided evidence for the noninferiority of artificial disc replacement. The superiority of ProDisc-L with circumferential fusion was achieved at 2 but not at 5 years in this unblinded trial. The potential benefits of the artificial disc (e.g., faster recovery, reduced adjacent-level disc degeneration) have not been demonstrated. Also, considerable uncertainty remains whether response rates will continue to decline over longer time periods and long-term complications with these implants will emerge. Although some randomized trials have concluded that this technology is noninferior to spinal fusion, outcomes that would make noninferiority sufficient to demonstrate the clinical benefit of the artificial lumbar disc have not been established. Because the artificial intervertebral disc is meant to last the lifetime of an individual, long-term randomized controlled trials evaluating the safety, effectiveness, and durability of these devices are needed.
0095T, 0098T, 0164T, 0165T, 22856, 22858, 22861, 22862, 22864, 22865
THE FOLLOWING CODE IS USED TO REPRESENT TOTAL DISC ARTHROPLASTY (ARTIFICIAL DISC), ANTERIOR APPROACH, INCLUDING DISCECTOMY WITH THE END PLATE PREPARATION (INCLUDED OSTEOPHYTECTOMY FOR NERVE ROOT OR SPINAL CORD DECOMPRESSION AND MICRODISSECTION), CERVICAL, THREE OR MORE LEVELS
M50.020 Cervical disc disorder with myelopathy, mid-cervical region, unspecified level
M50.021 Cervical disc disorder at C4-C5 level with myelopathy
M50.022 Cervical disc disorder at C5-C6 level with myelopathy
M50.023 Cervical disc disorder at C6-C7 level with myelopathy
M50.120 Mid-cervical disc disorder, unspecified level
M50.121 Cervical disc disorder at C4-C5 level with radiculopathy
M50.122 Cervical disc disorder at C5-C6 level with radiculopathy
M50.123 Cervical disc disorder at C6-C7 level with radiculopathy
M50.220 Other cervical disc displacement, mid-cervical region, unspecified level
M50.221 Other cervical disc displacement at C4-C5 level
M50.222 Other cervical disc displacement at C5-C6 level
M50.223 Other cervical disc displacement at C6-C7 level
M50.320 Other cervical disc degeneration, mid-cervical region, unspecified level
M50.321 Other cervical disc degeneration at C4-C5 level
M50.322 Other cervical disc degeneration at C5-C6 level
M50.323 Other cervical disc degeneration at C6-C7 level