Coverage Policy Manual
Policy #: 2004022
Category: Surgery
Initiated: June 2004
Last Review: March 2024
  Artificial Vertebral Disc, Lumbar Spine

Description:
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.
 
The most frequent cause of back pain requiring surgery, degenerative disc disease is common with age or trauma. Spine imaging, such as magnetic resonance imaging (MRI), computed tomography, or plain radiography, shows that lumbar disc degeneration is widespread but for most people does not cause symptoms. Potential candidates for artificial disc replacement have chronic low back pain attributed to degenerative disc disease, lack of improvement with nonoperative treatment, and no contraindications for the procedure, which include multilevel disease, spinal stenosis, spondylolisthesis, scoliosis, previous major spine surgery, neurologic symptoms, and other minor contraindications. Patients who require procedures in addition to fusion (e.g., laminectomy, decompression) are not candidates for the artificial disc.
 
When conservative treatment of degenerative disc disease fails, a common surgical approach is spinal fusion. More than 200,000 spinal fusions are performed each year. However, the outcomes of spinal fusion have been controversial, in part due to the difficulty in determining whether a patient's back pain is related to degenerative disc disease and in part due to the success of the procedure itself. In addition, spinal fusion alters the biomechanics, potentially leading to premature disc degeneration at adjacent levels, a particular concern for younger patients. During the past 30 years, various artificial intervertebral discs have been investigated as an alternative to fusion. This approach, also referred to as total disc replacement or spinal arthroplasty, is intended to maintain normal biomechanics of the adjacent vertebrae and motion at the operative level once the damaged disc has been removed.
 
Use of a motion-preserving artificial disc increases the potential for various types of implant failure. They include device failure (e.g., device fracture, dislocation, or wear), bone-implant interface failure (e.g., subsidence, dislocation-migration, vertebral body fracture), and host response to the implant (e.g., osteolysis, heterotopic ossification, pseudotumor formation).
 
 
Regulatory Status
Three artificial lumbar disc devices (activL®, Charité®, ProDisc®-L) have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process. Production under the name Charité® was stopped in 2010 and the device was withdrawn in 2012.
 
Because the long-term safety and effectiveness of these devices were not known when approved, approval was contingent on completion of postmarketing studies. The activL® (Aesculap Implant Systems) and ProDisc®-L (Synthes Spine) devices are indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographs. The activL device is approved for use at 1 level. Initial approval for ProDiscL was also limited to patients with disease at 1 level. In April 2020, the ProDiscL indication was expanded to include patients with disease at up to 2 consecutive levels (FDA, 2020).
 
U.S. Food and Drug Administration-Approved Lumbar Artificial Disc Devices
  • activL, manufactured by Aesculap Implant Systems, LLC
    • Indication - The activL Artificial Disc (activL) is indicated for reconstruction of the disc at one level (L4-L5 or L5-S1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (DDD) with no more than Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activL Artificial Disc is implanted using an anterior retroperitoneal approach. Patients receiving the activL Artificial Disc should have failed at least 6 months of nonoperative treatment prior to implantation of the device.
    • PMA Number - P120024.
    • Approval Date - 06/11/2015
  • ProDisc-L, manufactured by Synthes Spine
    • Indication - The PRODISC -L Total Disc Replacement is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at 1 or 2 contiguous intervertebral level(s) from L3-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level. Patients receiving the PRODISC®-L Total Disc Replacement should have failed at least six months of conservative treatment prior to implantation of the PRODISC®-L Total Disc Replacement.
    • PMA Number - P050010/S020
    • Approval Date - 8/25/2006 with supplement date of 4/10/2020
  • Charite, manufactured by Depuy Spine, Inc.
    • Indication - The Charite Artificial Disc is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at 1 level from L4-S I. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than 3 mm of spondylolisthesis at the involved level. Patients receiving the Charite Artificial Disc should have failed at least 6 months of conservative treatment prior to implantation of the CHARITE Artificial Disc.
    • PMA Number - P040006
    • Approval Date - 10/26/2004 Withdrawn 1/5/2012
 
A number of other artificial lumbar discs are in development or available only outside of the United States:
  • The INMOTION® lumbar artificial disc (DePuy Spine) is a modification of the Charité® device with a change in name under the same premarket approval. The INMOTION® is not currently marketed in the United States.
  • The Maverick™ artificial disc (Medtronic) is not marketed in the United States due to patent infringement litigation.
  • The metal-on-metal FlexiCore® artificial disc (Stryker Spine) has completed the investigational device exemption trial as part of the FDA approval process and is currently being used under continued access.
  • Kineflex-L™ (Spinal Motion) is a 3-piece, modular, metal-on-metal implant. An FDA advisory committee meeting on the Kineflex-L, scheduled in 2013, but was canceled without explanation.
 
FDA product code: MJO.

Policy/
Coverage:
Effective March 2015
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Lumbar artificial intervertebral disc replacement meets primary coverage criteria as an alternative to lumbar fusion in patients who meet ALL of the following:
 
    • Age 18 to 60 years old; and
    • Advanced single-level disease noted on an MRI and plain radiographs of the lumbar spine at L4-5 or L5-1, characterized by moderate to severe degeneration of the disc; and
    • Primary complaint of axial pain, with a possible secondary complaint of lower extremity pain; and
    • Presence of symptoms for at least one year that are not responsive to conservative treatment which should include a physical therapy/rehabilitation program; and
    • Absence of active significant psychiatric disorders, such as major depression, requiring pharmaceutical treatment; and
    • Absence of significant facet arthropathy at the operative level.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Lumbar artificial intervertebral disc replacement in all other situations does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, lumbar artificial intervertebral disc replacement in all other situations is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates.
 
Effective April 2012 to February 2015
The intervertebral disc prosthesis meets primary coverage criteria that there be scientific evidence of effectiveness when implanted at one level (i.e., L3-L4, L4-5 or L5-S1) according to the FDA approval of the device used, when all of the following criteria are met:
 
    • Patient is skeletally mature;
    • Patient has degenerative disc disease (DDD) at one level confirmed by patient history and radiographic studies and there is no more than Grade 1 spondylolisthesis at that level;  
    • Patient must have failed at least six months of conservative treatment prior to implantation of the artificial disc.
 
Effective prior to April 2012
The intervertebral disc prosthesis meets primary coverage criteria for effectiveness and is covered when implanted at one level, L4-5 or L5-S1 when all of the following criteria are met:
 
    • Patient is skeletally mature;
    • Patient has degenerative disc disease (DDD) confirmed by patient history and radiographic studies;
    • Patient must have failed at least six months of conservative treatment prior to implantation of the artificial disc.

Rationale:
Insertion of the artificial lumbar disc at more than one lumbar level is not covered because the safety and effectiveness of the artificial lumbar disc for treatment of more than one level of lumbar disc disease has not been determined, and therefore does not meet member benefit certificated Primary Coverage Criteria.
 
The FDA issued an approval of the Charite Artificial Disc on 10/26/04 (P040660).   
 
Several case series have been published describing the international experience with the SB Charlie device. LeMaitre summarized the results of the largest case series that included 105 patients with a mean follow-up of 51 months.  A total of 79% of patients reported an excellent result, with 87% returning to work. The intended segmental mobility was noted radiologically. Hoohsehtiler and colleagues summarized their experience with the SB Charite III device at the Texas Back Institute.  The series included 56 patients; 22 had 12 months of follow-up. There was significant improvement in pain and function, as measured by a visual analog scale and Oswestry Low Back Pain Disability questionnaire score, respectively.
 
The first report of Class I data comparing the lumbar artificial disc (n=205) to lumbar fusion (n=99) stated neurological status was equivalent  between the two groups at 6, 12, and 24 months.  The number of patients with major, minor, or other neurological complications was equivalent.
 
2012 Update
Five-year results of the ProDisc®-L randomized, controlled trial were published (Zigler, 2012). Out of an original 236 patients randomize, 229 were available for 2-year follow-up and 103 were available for 5-year follow-up. The primary outcome of the trial was a composite endpoint that consisted of change in the Oswestry Disability Index (ODI) and Short Form (SF)-36 physical component score, current neurological status, absence of secondary surgical intervention at the index level, range of motion, and various measures of radiographic success. At 2 years, overall success was achieved in 63.5% of ProDisc®-L patients and 45.1% of fusion patients; ProDisc®-L was found to be both non-inferior and superior to circumferential fusion. Five-year results showed non-inferiority, but not superiority of artificial disc replacement, with 53.7% of ProDisc®-L patients and 50.0% of fusion patients achieving overall success. This change in overall success in ProDisc®-L patients between 2 and 5 years indicate a possible decrement in response over time with the artificial disc. This decrement in response rate was not observed in the standard fusion group, and resulted in convergence of the primary outcome measures between groups over time.
 
The 5-year results of this trial provide additional support for the non-inferiority of artificial disc replacement. Superiority of ProDisc®-L to circumferential fusion was achieved at 2, but not 5 years in this trial. Currently, the potential benefits of the ProDisc®-L, such as faster recovery or reduced adjacent level disc degeneration, have not been demonstrated. In addition, considerable uncertainty remains about whether response rates will continue to decline over longer time periods, along with the potential for long-term complications with these implants.
 
2014 Update
A search of the MEDLINE database conducted through March 2014 did not reveal any new information that would prompt a change in the coverage statement.
  
2015 Update
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement.
 
The pivotal study for the Kineflex artificial disc was a randomized controlled trial that compared the Kineflex-L with an artificial disc (Charite) that was already approved for sale (Guyer, 2014). There were 261 patients in the Kineflex group and 196 patients in the Charite group. The primary outcome measure for the published study was a composite success measure at 24 months of at least 15-point improvement in ODI score, no subsequent operative intervention related to the device and no major adverse events. Twenty-four month follow-up was obtained in 94.8% of the Kineflex-L group and 91.3% of the Charite group. There were no significant differences between the Kineflex-L and Charite groups for overall success (76.5% vs 74.7%, respectively) or in the individual components of success. Reoperations were performed in 10.3% of the Kineflex-L group and 8.4% of the Charite group. In the Kineflex group, the 11 reoperations were due to lymphocytic reaction (n=2), device migration (n=2), and supplemental fixation implantations (n=5). In 2011, the authors of this study had published a report of early failure of metal-on-metal disc prostheses in 4 patients due to a lymphocytic reaction, similar to that observed in metal-on-metal hip implants.  A FDA advisory committee meeting on the Kineflex lumbar disc was scheduled for July 2013, but was cancelled without explanation.
 
Siepe et al reported minimum 5-year follow-up 181 patients implanted with the ProDisc II at their institution (Siepe, 2014). This represented 90.0% of the initial cohort of 201 patients from this prospective clinic-funded quality review study. Disc replacement was performed for the treatment of predominant (80%) axial low back pain. Radiculopathy was a contraindication, and all patients underwent fluoroscopically guided infiltrations of the facet and and sacroiliac joints to rule out nondiscogenic pain sources. Baseline ODI and VAS pain scores, assessed by investigators who were not involved in pre- or postoperative decision making, were approximately 42 and 7.1, respectively. After a mean of 7.4 years (range 5.0-10.8 years), VAS pain scores remained significantly improved over baseline (mean of 3.3, p<0.0001), although a slight deterioration (0.66 on a scale of 10) was observed between 48 and 120 months (p<.05). ODI scores remained stable throughout follow-up, with a final score of approximately 22 (p<0.001). The complication rate for single level disc replacement was 11.9% compared with 27.6% for bi-segmental disc replacement (p=0.031). The overall satisfaction rate was 89.1% for single level and 69.0% for two-level disc replacement.
 
Five-year results of lumbar disc arthroplasty from the Swiss Spine Registry were published in 2014 (Aghayev, 2014). Five devices were used during the period of study (Activ L, Charite, Dynardi, Maverick, and ProDisc-L). Out of 248 patients who were eligible for the 5-year study, follow-up was obtained from 77% of patients at 1 year, 44% at 2 years, and 51.2% at 5 years. In the 127 patients with follow-up through 5 years, there was a significant reduction of VAS back pain (from 73 to 29) and leg pain (from 55 to 22). Note that the presence of radiculopathy does not appear to have been an exclusion for disc arthroplasty at these institutions. The overall complication rate at 5 years was 23.4% which included a new radiculopathy in 10.5% of patients, the rate of adjacent segment degeneration was 10.7%, and 43.9% of patients had osteophytes that could potentially affect the range of motion. The cumulative probability of survivorship at 5 years was calculated to be 90.4%.
 
2017 Update
A literature search conducted through February 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A five-year follow-up was available for 66.0% of patients randomized to Kineflex-L and 70.9% of patients randomized to the Charité artificial disc (Guyer, 2016). Overall success rates were similar to those reported at 2 years. The percentage of patients undergoing subsequent surgery at the index level was 11.8% for the Kineflex- L group (including 2 device removed due to lymphocytic reaction) and 11.6% for the Charité group. Interpretation of the 5-year results is difficult due to high loss to follow-up.
 
Two-year outcomes from the multicenter IDE trial of the activL artificial intervertebral disc were reported by Garcia and colleagues (Garcia, 2015). In this patient-blinded noninferiority trial, patients with DDD at L4-L5 or L5-S1 were randomized to treatment with activL (n=218) or an FDA-approved disc (n=106; ProDisc-L or Charité). Based on the primary composite end point (a 15 point improvement on ODI score, maintenance or improvement in neurologic status, maintenance or improvement in range of motion at the index level, freedom from additional surgery at the index level, freedom from serious device-related adverse events), activL was both noninferior (p<0.001) and superior (p=0.02) to the control group. Intention-to-treat analysis of secondary outcome measures showed similar improvements between activL and controls in back pain (74% vs 68%), ODI scores (75.2% vs 66.0%), device success (84.4% vs 84.9%), surgical reintervention (2.3% vs 1.9%), and patient satisfaction scores for the 2 groups (94.1% vs 93.1%), all respectively. Radiographic success, defined as maintenance or improvement in range of motion at the index level as measured by an independent core radiographic laboratory, was higher in the activL group than in the ProDisc-L and Charité controls (59% vs 43%, p<0.01).
 
 
In 2015, Lu and colleagues reported minimum 11-year follow-up on 32 of 35 patients implanted with the Charité III (Lu, 2015). Of the 3 patients not included in this prospective study, 1 chose not to participate, 1 was lost to follow-up, and 1 died of unrelated causes. Prior to surgery, VAS score for back pain was 8.5 and ODI score was 41.4; the mean duration of symptoms was 5.4 years. At an average of 11.8 years after device implantation (range, 11.3-13.8 years), VAS score improved to 1.5 (p=0.0015), ODI score improved to 13.2 (p=0.0047), and 87.5% had a successful outcome based on FDA criteria. There were no device failures or major complications (1 patient developed severe leg pain associated with adjacent segment degeneration and had spinal decompression). Heterotopic ossification was observed in 71.4% of segments, but was associated with a decrease in range of motion in only 25.7% of segments. The authors proposed several reasons for the high success rate in this group, including strict selection criteria and the lighter body weight of most Chinese compared to Western patients (eg, less load on the prosthesis).
 
In 2015, Hoff and colleageus published an RCT with 62 patients that compared a hybrid procedure (anterior lumbar interbody fusion at 1 level and a Maverick disc at another level) to 2-level circumferential fusion (Hoff, 2015). VAS score for pain was significantly lower by about 1 point on a 10-cm scale in the hybrid group compared to the 2-level fusion group both postoperatively and at 3-year follow-up. There was no significant difference between groups in ODI scores. ASD did not differ significantly between groups.
 
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed below:
Ongoing
(NCT02381574) French Lumbar Total Disk Replacement Observational Study (FLTDR Observational Study); planned enrollment 600; projected completion date December 2020.
 
Unpublished
(NCT01704677) Lumbar Disc Prosthesis versus Multidisciplinary Rehabilitation in Chronic Back Pain and Localized Degenerative Disc. Long Term Follow-up of a Randomized Multicentre Trial; planned enrollment 151; projected completion date (November 2015) (completed)
 
2018 Update
 
Annual policy review completed with a literature search using the MEDLINE database through February 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2017, Ding et al reported on a systematic review of 5 overlapping meta-analyses that compared total disc replacement (TDR) to fusion for DDD.4 The primary studies for the meta-analyses were published between 2005 and 2011. The 5 meta-analyses arrived at different conclusions, but the highest quality
review was determined to be a 2012 Cochrane review with an AMSTAR rating of 9.5 Cochrane reviewers concluded that, although there were statistically significant improvements in clinical outcomes of disability, pain relief, and quality of life with TDR for DDD in the short term, the differences were not  clinically significant. In addition, prevention of adjacent segment and facet joint degeneration had not been adequately evaluated. Given the uncertainty of risks and benefits in the long-term, caution was advised. A limitation of the 2012 Cochrane review is that many of the selected studies used a Charité disc, which is no longer marketed in the United States.  
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement. The key literature is summarized below.
 
Hellum et al reported an RCT that compared the use of the ProDisc-L with a multidisciplinary rehabilitation program (Hellum, 2011). Patients (N=173) were ages 25 to 55 years, had low back pain for a least a year, received physical therapy or chiropractic treatment for at least 6 months without sufficient effect, had an ODI score of at least 30, and showed degenerative intervertebral changes that included at least 40% reduction of disc height, Modic changes, a high-intensity zone in the disc, and morphologic changes identified as changes in the signal intensity in the disc of grade 3 or 4. The multidisciplinary rehabilitation included a cognitive approach and supervised physical exercise. The primary outcome was ODI score, and the trial was powered to detect a 10-point difference in ODI score. The analysis was intention-to-treat with the last observation carried forward. There were 13 (15%) dropouts in the surgical arm and 21 (24%) in the rehabilitation arm. Also, 5 (6%) patients crossed over from rehabilitation to surgery. Of the 34 patients lost to follow-up, 26 answered a questionnaire between 2.5 and 5 years after treatment. In the intention-to-treat analysis, there was a statistically significant benefit of surgery, but the mean difference did not achieve the 10-point difference in ODI score considered clinically significant. There were significantly more patients who achieved a 15-point improvement in ODI score in the ProDisc group, with a number needed to treat of 4.4. The radiographic assessment identified a similar level of adjacent segment degeneration in both groups, but an increase in facet arthropathy in the ProDisc II group (Hellum, 2012). In 2017, Furunes reported eight-year follow-up of this trial (Furunes, 2017). In both the intention-to-treat and per-protocol analysis there was a statistically significant benefit of surgery as measured by the mean ODI, but these differences did not reach the clinically significant threshold of 10 points. More patients in the surgery group (43/61 [70%]) reached a clinically important difference of 15 ODI points than in the rehabilitation group (26/52 [50%]; p=0.03). Twenty-one (24%) patients randomized to rehabilitation crossed over to surgery while 12 (14%) patients randomized to surgery had undergone additional back surgery.
 
activL
Laugesen et al found significant improvements in pain and function with 1- or 2-level ProDisc II implantation at follow-up of 10.6 years, but pain remained moderate, and about one-third of patients required revision to fusion (Laugesen, 2017). The authors noted the need for appropriate selection criteria.
 
2020 Update
A literature search was conducted through February 2020.  There was no new information identified that would prompt a change in the coverage statement.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Five-year results from this trial were reported in Yue et al. Of 341 patients enrolled, 261 contributed data at 5 years (76.5%) (Yue, 2019). The primary composite endpoint results were reported graphically only and demonstrated noninferiority at 5 years for activL versus control artificial discs. Sensitivity analyses using various imputation methods for missing data also showed noninferiority of activL, with the exception of the worst-case scenario (missing data counted as failure for activL and success for control). Freedom from serious adverse events through 5 years was 64% with activL and 47% with control artificial discs (P=0.0068).
 
Because this study compared activL to other fusion devices, it provides only indirect evidence of effectiveness compared to fusion or conservative care. The study was not powered to detect differences by different control devices, and the control group includes patients who received a device that is no longer available in the United States. Additional limitations were a high loss to follow-up at 5 years, unblinded outcome assessment, and no blinding of patients at the 5-year assessment.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
There are no RCTs of activL compared to fusion or conservative treatment.
 
Two-year outcomes from the multicenter investigational device exemption trial of the activL artificial intervertebral disc were reported by Garcia et al (Garcia, 2015). In this patient-blinded noninferiority trial, patients with degenerative disc disease were randomized to treatment with activL or an FDA approved disc (ProDisc-L or Charité). At 2 years, activL was both noninferior and superior to the control group of patients treated with ProDisc-L or Charité. Intention-to-treat analysis of secondary outcome measures showed similar improvements between activL and controls. Range of motion at the index level, measured by an independent core radiographic laboratory, was higher in the activL group than in the controls.
 
Five-year results from this trial were reported in Yue et al (Yue, 2019). Of 341 patients enrolled, 261 contributed data at 5 years (76.5%). The primary composite endpoint results were reported graphically only and demonstrated noninferiority at 5 years for activL versus control artificial discs. Sensitivity analyses using various imputation methods for missing data also showed noninferiority of activL, with the exception of the worst-case scenario (missing data counted as failure for activL and success for control). Freedom from serious adverse events through 5 years was 64% with activL and 47% with control artificial discs (P=0.0068). Seven-year results for 206 individuals who received activL or ProDisc-L were reported in Radcliff et al and showed no increase in serious adverse events between years 5 and 7 (Radcliff, 2021).
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
An updated TEC Assessment (2013) evaluated 5-year follow-up from the ProDisc pivotal trial (BCBSA TEC, 2013).
 
    • Additional study of ProDisc in an appropriately powered clinical trial with minimum 5-year follow-up is needed to confirm the results of the investigational device exemption trial in patients with single-level chronic symptomatic degenerative disc disease unresponsive to conservative management.
    • Questions remain about the durability of the disc, in particular, the long-term effects on patient health of polyethylene wear debris. Surgical revision of a failed or dysfunctional disc may be complicated and dangerous to the patient, so the lifespan of a prosthetic device is a key issue.
    • The main claim of the artificial disc-that it maintains range of motion and thereby reduces the risk of adjacent-level segment degeneration better than fusion-remains subject to debate.

CPT/HCPCS:
0163TTotal disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), each additional interspace, lumbar (List separately in addition to code for primary procedure)
0164TRemoval of total disc arthroplasty, (artificial disc), anterior approach, each additional interspace, lumbar (List separately in addition to code for primary procedure)
0165TRevision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, lumbar (List separately in addition to code for primary procedure)
22857Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), single interspace; lumbar
22860Total disc arthroplasty, anterior approach, including discectomy ; second lumbarinterspace
22862Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar
22865Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar

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Anderson PA, Rouleau JP.(2004) Intervertebral disc arthroplasty. Spine 2004; 29:2779-86.

Blue Cross and Blue Shield Association Technology Evaluation Center (BCBSA TEC).(2013) Artificial lumbar disc arthroplasty. TEC Assessments. 2013;Volume 28:Tab 7.

Ding F, Jia Z, Zhao Z, et al.(2017) Total disc replacement versus fusion for lumbar degenerative disc disease: a systematic review of overlapping meta-analyses. Eur Spine J. Mar 2017;26(3):806-815. PMID 27448810

Furunes H, Storheim K, Brox JI, et al.(2017) Total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain and degenerative discs: 8-year follow-up of a randomized controlled multicenter trial. Spine J. Oct 2017;17(10):1480-1488. PMID 28583869

Garcia R, Jr., Yue JJ, Blumenthal S, et al.(2015) Lumbar Total Disc Replacement for Discogenic Low Back Pain: Two-year Outcomes of the activL Multicenter Randomized Controlled IDE Clinical Trial. Spine (Phila Pa 1976). Dec 2015;40(24):1873-1881. PMID 26630435

Geisler FH, Blumenthal SL, Guyer RD, et al.(2004) Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study. Neurosurg Spine 2004; 1:143-54.

Guyer RD, McAfee PC, Hoshschuler SH, et al.(2004) Prospective randomized study of the Charite artificial disc: date from two investigational centers. Spine 2004; 4:S252-9.

Guyer RD, Pettine K, Roh JS, et al.(2014) Comparison of 2 lumbar total disc replacements: results of a prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month follow-up. Spine (Phila Pa 1976). May 20 2014;39(12):925-931. PMID 24718066

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Hellum C, Johnsen LG, Storheim K, et al.(2011) Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ. May 19 2011;342:d2786. PMID 21596740

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Hoff EK, Strube P, Pumberger M, et al.(2015) ALIF and total disc replacement versus 2-level circumferential fusion with TLIF: a prospective, randomized, clinical and radiological trial . Eur Spine J. Mar 7 2015. PMID 25749689

Laugesen LA, Paulsen RT, Carreon L, et al.(2017) Patient-reported Outcomes and Revision Rates at a Mean Follow-up of 10 Years After Lumbar Total Disc Replacement. Spine (Phila Pa 1976). Nov 1 2017;42(21):1657-1663. PMID 28368983

Lemaire JP, Skalli W, Lavaste F, et al.(1997) Intervertebral disc prosthesis. Results and prospects for the year 2000. Cho Orthop 1997; 337:64-76.

Lu SB, Hai Y, Kong C, et al.(2015) An 11-year minimum follow-up of the Charite III lumbar disc replacement for the treatment of symptomatic degenerative disc disease. Eur Spine J. Sep 2015;24(9):2056-2064. PMID 25895882

North American Spine Society (NASS).(2014) NASS policy coverage recommendations: Lumbar Artificial Disc Replacement. 2014; https://www.spine.org/Documents/PolicyPractice/CoverageRecommendations/LumbarArtificialDiscReplacement.pdf. Accessed February 2015.

Radcliff K, Zigler J, Braxton E, et al.(2021) Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results. Int J Spine Surg. Aug 2021; 15(4): 612-632. PMID 34266934

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