Medical Policy
Artificial Cervical Disc Replacement
Effective Date: April 1, 2017
Subject: Artificial Cervical Disc Replacement
Background: Artificial cervical disc replacement (i.e., surgical removal of degenerative cervical disc and
replacement with an artificial device) is an alternative to anterior cervical discectomy and fusion (ACDF) for
individuals suffering from neck pain due to degenerative disc disease. The primary advantage of the artificial
cervical disc over current therapies for degenerated disks (e.g., spinal fusion, diskectomy) is that implantation is
intended to restore or preserve the natural biomechanics of the intervertebral segment and to reduce further
degeneration of adjacent levels.
Contraindications for artificial intervertebral cervical disc devices include, but are not limited to, the following:
 Active systemic infection or infection at the operating site;
 Osteoporosis (i.e., DEXA bone mineral density T-score equal to or worse than 2.5);
 Marked cervical instability on neutral resting lateral or flexion/extension radiographs;
 Moderate to advanced spondylosis characterized by bridging osteophytes, marked reduction or absence of
motion, or collapse of the intervertebral disc space of greater than 50% of its normal height;
 Clinically compromised vertebral bodies at the affected level due to current or past trauma (e.g., by
radiographic appearance of fracture callus, malunion, or nonunion).
Authorization:
Prior Authorization, through the National Imaging Associates, is required.
Policy and Coverage Criteria:
Harvard Pilgrim Health Care (HPHC) considers implantation of FDA-approved prosthetic intervertebral disc(s)
medically necessary when a member meets ALL the following criteria:
1. The individual is skeletally mature and has no history of prior neck surgery;
2. The individual has intractable radiculopathy caused by one or two level disease (either herniated disc or
spondolytic osteophyte) located at C3-C7;
3. The individual has persistent or recurrent symptoms/pain, and functional limitations that are unresponsive to
at least 6 weeks of appropriate conservative treatment including NSAID medication, activity modification, and
a dedicated program of physical therapy/rehabilitation;
4. Imaging studies (MRI or CT) confirm the presence of compression at the level(s) corresponding with the
clinical findings;
5. The individual has refrained from smoking and/or nicotine use for at least six weeks prior to surgery.
Exclusions:
Harvard Pilgrim Health Care (HPHC) does not cover artificial cervical disc replacement when criteria above are not
met.
Supporting Information:
Intervertebral discs are composed of an outer fibrocartilage ring, the annulus fibrosus, and an inner core, the
nucleus pulposus, which contains loose fibers suspended in a mucoprotein gel. The discs function as shock
absorbers, maintain separation of adjacent vertebrae, and allow smooth movement of the spine. Degeneration of
intervertebral discs occurs with small tears or cracks in the outer annulus. These can progress to larger tears and
resorption of the internal disc, which leads to loss of disc height and instability of the spinal segment. These
changes result in further disc resorption, disc-space narrowing, endplate narrowing and destruction, disc fibrosis,
and osteophyte formation. Loss of disc height and osteophyte formation can cause compression of spinal nerve
roots.
Artificial disc replacement is an alternative to fusion. An advantage of disc replacement over fusion is that a
prosthetic disc helps preserve normal range of motion and mechanics of the spine. This reduces the long-term
degenerative changes in adjacent vertebral segments that have been observed following fusion.
Davis et al. (2015) analyzed 330 patients who underwent surgery for degenerative disc disease (DDD) and
followed for 48 months. Of the 330 patients, 225 patients received the Mobi-C TDR device and 105 received
ACDF. TDR was found to have statistical superiority over ACDF at 24 months postoperatively. At 48 months, both
groups demonstrated improvement in clinical outcome measures and a comparable safety profile. TDR patients
experienced significantly greater improvements than ACDF patients in the following outcome measures compared
with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary
scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and
displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients
maintained segmental range of motion through 48 months with no device failure. Four-year results from this
study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment
of degenerative disc disease at 2 contiguous cervical levels.
Bae et al. (2013) followed the cohort from the Davis (2013) study mentioned above at 48 months
postoperatively. The TDR group continued to have statistically superior overall success compared with the ACDF
group through 48 months.
Huppert et al. (2011) compared the safety and efficacy of single-level disc replacement versus multi-level disc
replacement in patients with cervical DDD. Single-level cervical TDR was performed in 175 patients and multilevel cervical TDR was performed at 2-4 levels in 56 patients. In both groups, a significant improvement was
reported by self-assessment at all time-points postoperatively. A significant decrease was reported in mean NDI,
radicular VAS and cervical VAS in both groups at all time-points postoperatively compared with pre-operative
values. Postoperatively, the single-level group returned to work after an average of 4.8 months versus 7.5
months in the multi-level group. In the single-level group, among the patients who used analgesics preoperatively, there was a significant decrease in analgesic use postoperatively (68%) at 2 year follow-up.
Murrey et al. (2009) compared the safety and outcomes of the ProDisc-C total disc replacement versus ACDF in
patients with single-level symptomatic cervical DDD. There was a significant decrease in the TDR group in NDI
and SF-36 scores at all follow up visits compared with preoperative scores. The TDR group also showed a
significant decrease in VAS arm and neck pain intensity and frequency at all follow-up visits compared with
preoperative scores. Significantly less TDR patients (1.8%) required re-operation, revision, or supplemental
fixation within the 24 month postoperative period compared with the ACDF group (8.5%).
Heller et al. (2009) conducted a study comparing Bryan Cervical Disc device with ACDF in patients with cervical
DDD. 242 patients received the Bryan cervical disc and 221 patients underwent a single-level ACDF. At 24 months
postoperative follow-up, the group that received the artificial disc had a statistically greater improvement in NDI
scores and overall success compared with the ACDF group.
Mummaneni et al. (2007) compared the results of cervical disc arthroplasty with ACDF in patients treated for
symptomatic single-level cervical DDD. Postoperative analysis at 12 and 24 months indicated a greater
improvement in the NDI score in the TDR group than the ACDF group. The TDR group also had a statistically
significant higher rate of neurological success as well as a lower rate of secondary revision surgeries and
supplemental fixation. The patients in the TDR group returned to work 16 days sooner than those in the ACDF
group, and the rate of adjacent-segment reoperation was significantly lower in the TDR group as well. The
cervical disc implant maintained segmental sagittal angular motion averaging more than 7°. In the TDR group,
there were no cases of implant failure or migration.
NICE Guidelines: “Current evidence on the efficacy of prosthetic intervertebral disc replacement in the cervical
spine shows that this procedure is as least as efficacious as fusion in the short term and may result in a reduced
need for revision surgery in the long term. The evidence raises no particular safety issues that are not already
known in relation to fusion procedures. Therefore, this procedure may be used provided that normal
arrangements are in place for clinical governance, consent and audit.”
Coding: Codes are listed below for informational purposes only, and do not
guarantee member coverage or provider reimbursement. The list may not be allinclusive. Deleted codes and codes which are not effective at the time the service is
rendered may not be eligible.
CPT Codes:
 22856: Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate
preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection),
single interspace, cervical
 22858: Total disc arthroscopy (artificial disc), anterior approach, including discectomy with end plate
preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection);
second level, cervical (List separately in addition to code for primary procedure)
References:
1. Bae H., Davis R., Gaede S., Hisey M., Kim K., Nunley P. Mobi-C cervical disc investigational device exemption
trial two-level study, 48 month results. 2013 annual meeting for the NASS and CSRS. MB CP 1 REV A
02.2014.
2. Huppert J., Beaurain J., Steib JP., Bernard P., Dufour T., Hovorka I., Stecken J., Dam-Hieu P., Fuentes JM.,
Vital JM., Vila JM., Aubourg L. Comparison between single- and multi-level patients: clinical and radiological
outcomes 2 years after cervical disc replacement. Eur Spine J. 2011; 20:1417-1426.
3. Murrey D., Janssen M., Delamarter R., Goldstein J., Zigler J., Tay B., Darden B. Results of the prospective,
randomized, controlled multicenter Food and Drug Administration investigational device exemption study of
the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level
symptomatic cervical disease. The Spine Journal. 2009; 9(4):275-286.
4. Heller JG., Sasso RC., Papadopoulos SM., Anderson PA., Fessler RG., Hacker RJ., Coric D., Cauthen JC., Riew
DK. Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical
and radiographic results of a randomized, controlled, clinical trial. Spine. 2009; 34(2):101-107.
5. Mummaneni PV., Burkus JK., Haid RW., Traynelis VC., Zdeblick TA. Clinical and radiographic analysis of
cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J of Neurosur:
Spine. 2007; 6(3):198-209.
6. Davis RJ, Nunley PD, Kim KD, Hisey MS, Jackson RJ, Bae HW, Hoffman GA, Gaede SE, Danielson GO 3rd,
Gordon C, Stone MB. Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior
discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up
results. J Neurosurg Spine. 2015 Jan;22(1):15-25.
7. Cheng L, Nie L, Zhang L, Hou Y. Fusion versus Bryan Cervical Disc in two-level cervical disc disease: a
prospective, randomised study. Int Orthop. 2009 Oct;33(5):1347-51.
8. Prosthetic intervertebral disc replacement in the cervical spine | 1-guidance | Guidance and guidelines | NICE.
Niceorguk. 2017. Available at: http://www.nice.org.uk/guidance/ipg341/chapter/1-guidance. Accessed
February 14, 2017.
Summary of Changes:
Date
Change
01/11/17
Add Background information describing artificial cervical disc replacement
and contraindications. Update Criteria to incorporate one or two level disease
(consistent with NIA recommendation). Update literature review,
benchmarks, references. Add CPT 22858 as covered service, and add coding
disclaimer.
Approved by UMCPC: 1/11/17
 Reviewed/Revised: 12/15; 1/17
 Initiated: 7/15