MEDICAL POLICY
POLICY
RELATED POLICIES
POLICY GUIDELINES
CODING
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
APPENDIX
HISTORY
Artificial Intervertebral Disc: Lumbar Spine
Number
7.01.87
Effective Date
July 1, 2016
Revision Date(s) 06/14/16; 08/11/15; 03/10/14; 12/09/13; 11/13/12; 12/13/11;
12/14/10; 12/08/09; 01/13/09; 02/12/08; 08/14/07; 03/13/07;
09/12/06; 07/11/06; 05/10/05; 01/01/04; 08/12/03
Replaces
N/A
Policy
[TOP]
Artificial intervertebral discs of the lumbar spine are considered investigational.
Related Policies
[TOP]
7.01.108
Artificial Intervertebral Disc: Cervical Spine
7.01.120
Facet Arthroplasty
7.01.542
Lumbar Spinal Fusion
7.01.551
Lumbar Spine Decompression Surgery: Discectomy, Foraminotomy, Laminotomy, Laminectomy
Policy Guidelines
[TOP]
Coding
0163T
0164T
0165T
22857
22862
22865
0RRB0JZ
0SR20JZ
CPT
Total 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)
Removal of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, lumbar (List
separately in addition to code for primary procedure)
Revision including replacement of total disc arthroplasty, anterior approach, each additional interspace,
lumbar (List separately in addition to code for primary procedure)
Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other
than for decompression), single interspace, lumbar
Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace;
lumbar
Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar
ICD-10
Replacement of Thoracolumbar Vertebral Disc with Synthetic Substitute, Open Approach
Replacement of Lumbar Vertebral Disc with Synthetic Substitute, Open Approach
0SR40JZ
0SR20JZ
0SR40JZ
0SR20JZ
0SR40JZ
Replacement of Lumbosacral Disc with Synthetic Substitute, Open Approach
Replacement of Lumbar Vertebral Disc with Synthetic Substitute, Open Approach
Replacement of Lumbosacral Disc with Synthetic Substitute, Open Approach
Replacement of Lumbar Vertebral Disc with Synthetic Substitute, Open Approach
Replacement of Lumbosacral Disc with Synthetic Substitute, Open Approach
NOTE: Artificial intervertebral discs for treating the cervical spine are addressed in a separate medical policy
(see Related Policies).
Description
[TOP]
Total disc replacement, using an artificial intervertebral disc designed for the lumbar spine, is proposed as an
alternative to fusion in patients with persistent and disabling nonradicular low back pain.
Background
When conservative treatment of degenerative disc disease (DDD) 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 over the years, in part due to the difficulty in determining if a patient's back pain is related to
DDD and in part due to the success of the procedure itself. In addition, spinal fusion alters the biomechanics of
the back, potentially leading to premature disc degeneration at adjacent levels, a particular concern for younger
patients. During the past 30 years, a variety of artificial intervertebral discs have been investigated as an
alternative approach to fusion. This approach, also referred to as total disc replacement or spinal arthroplasty, is
intended to maintain motion at the operative level once the damaged disc has been removed and to maintain the
normal biomechanics of the adjacent vertebrae.
Potential candidates for artificial disc replacement have chronic low back pain attributed to DDD, lack of
improvement with nonoperative treatment, and none of the contraindications for the procedure, which include
multilevel disease, spinal stenosis, or spondylolisthesis, scoliosis, previous major spine surgery, neurologic
symptoms, and other minor contraindications. These contraindications make artificial disc replacement suitable
for a subset of patients in whom fusion is indicated. Patients who require procedures in addition to fusion, such as
laminectomy and/or decompression, are not candidates for the artificial disc.
Use of a motion-preserving artificial disc increases the potential for a variety of types of implant failure. These
include device failure (device fracture, dislocation, or wear), bone-implant interface failure (subsidence,
dislocation-migration, vertebral body fracture), and host response to the implant (osteolysis, heterotopic
ossification, and pseudotumor formation).
Regulatory Status
While artificial intervertebral discs in the lumbar spine have been used internationally for more than 10 years, only
3 devices (activL®, Charité®, ProDisc®-L) have been approved by the U.S. Food and Drug Administration (FDA)
through the premarket approval process. Because the long-term safety and effectiveness of these devices were
not known, approval was contingent on completion of postmarketing studies. The activL® (Aesculap Impant
Systems), Charité® (DePuy) and ProDisc®-L (Synthes Spine) devices are indicated for spinal arthroplasty in
skeletally mature patients with degenerative disc disease (DDD) at 1 level; activL and Charité are approved for
use in levels L4-S1, and the ProDisc®-L is approved for use in levels L3-S1. DDD is defined as discogenic back
pain with degeneration of the disc confirmed by patient history and radiographic studies. The INMOTION® lumbar
artificial disc (DePuy Spine) is a modification of the Charité® device with a change in name under the same
premarket approval. Production under the name Charité® was stopped in 2010. 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
IDE trial as part of the FDA process of approval and is currently being used under continued access. (Artificial
intervertebral discs for treating the cervical spine are considered separately in evidence review 7.01.108.)
Kineflex-L™ (Spinal Motion) is a 3-piece modular metal-on-metal implant. An FDA advisory committee meeting on
the Kineflex-L was scheduled for July 2013, but was cancelled without explanation. FDA product code: MJO.
Scope
[TOP]
Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject
to the limits and conditions of the member benefit plan. Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply. This medical policy does not apply to Medicare Advantage.
Benefit Application
[TOP]
N/A
Rationale
[TOP]
Populations
Individuals:
 With lumbar degenerative
disc disease
Interventions
Interventions of interest
are:
 Lumber artificial
intervertebral disc
Comparators
Comparators of interest
are:
 Conservative therapy
 Lumbar spinal fusion
Outcomes
Relevant outcomes include:
 Symptoms
 Functional outcomes
 Quality of life
 Treatment-related morbidity
This policy was created in 2003 and has been periodically updated using the MEDLINE® database. The most
recent literature review of this policy was performed through February 9, 2016. Following is a summary of key
literature to date.
When this policy was created in 2003, the only evidence available was several case series describing the
international experience with the SB Charité® device. In February 2005, TEC completed an assessment of
artificial disc replacement, focusing on the Charité® lumbar disc device. (1) Only 1 completed randomized
controlled trial (RCT) had evaluated the Charité® artificial disc compared with the BAK fusion cage for the
treatment of single-level degenerative disc disease (DDD).(2) The ProDisc®, FlexiCore®, and Maverick™ devices
were also undergoing investigation in similarly designed randomized trials. The 2005 TEC Assessment concluded
that, compared with fusion or other treatments, evidence supporting the effectiveness of artificial vertebral discs in
terms of pain relief and restoration of function among patients with chronic discogenic low back pain was
insufficient. In August 2006 the ProDisc-L® was approved by the U.S. Food and Drug Administration (FDA).(3, 4)
An updated TEC Assessment in February 2007 reviewed the evidence on artificial lumbar disc replacement
devices.(5) The Assessment concluded that given what is known about fusion as a comparator treatment, neither
of the noninferiority trials provided convincing evidence of efficacy. TEC concluded that the evidence supporting
the effectiveness of the ProDisc-L® and Charité® artificial disc was limited and that there was no immediately
discernible advantage to use of the artificial disc. In 2010, 2 systematic reviews concluded that high-quality RCTs
with a relevant control group and long-term follow-up are needed to evaluate the effectiveness and safety of
artificial lumbar disc replacement.(6, 7)
In 2012, a systematic review by Wang et al evaluated the risk of adjacent segment disease (ASD) with disc
replacement versus fusion.(8) Analysis of data from 2 randomized trials (9, 10) found a pooled risk of ASD treated
surgically to be 1.2% following lumbar disc replacement and 7.0% following fusion. The number needed to harm
was calculated to be 17. In one of the studies (9) included in this systematic review, ASD was marginally reported,
and the number of any reoperations did not differ between disc replacement and fusion. Limitations of the second
trial (10) are described next. A 2012 Cochrane review of 7 studies concluded that while differences between disc
replacement and fusion were statistically significant, they did not achieve clinically important differences for shortterm pain relief, disability, or quality of life. (11) Concerns included the highly selected population, the lack of
proper assessment of the primary goal of prevention of adjacent-level disease and facet joint degeneration, and
the potential for harm in the long-term.
An updated TEC Assessment in 2013 evaluated the 5-year follow-up from the pivotal trial of the ProDisc.(12) The
Assessment concluded that:
 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 (IDE) trial in patients with singlelevel chronic symptomatic DDD 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.
Charité (INMOTION®)
The Charité device is no longer marketed under that name. The INMOTION® artificial disc is a renamed and
slightly modified version of the Charité. It is not currently marketed in the United States.
Controlled Trials
The pivotal study for the Charité device consisted of an RCT comparing the artificial intervertebral disc with spinal
fusion using a threaded fusion cage with autologous bone graft. (2) Patients were randomly assigned in a 2:1
fashion, with 205 receiving the artificial disc and 99 undergoing fusion. In this trial’s analysis of 267 patients
followed up for up to 24 months, the Charité artificial disc had a success rate of 63% compared with a success
rate of 53% for BAK (Bagby and Kuslich [BAK]) fusion, using a composite measure of outcomes that incorporated
improvement of symptoms and absence of complications. The analysis showed noninferiority compared with BAK
fusion using the composite measure of success but did not show statistically significant superiority in most
outcome measures. The point estimate of 63% success did not show the artificial disc to be a highly successful
treatment. In addition, the long-term effectiveness and health outcomes for artificial vertebral discs were
uncertain.
In 2009, Guyer et al. reported 5-year follow-up of a subset of the patient cohort that had participated in the IDE
trial of the Charité artificial disc (previously described). (10) Of the initial 14 sites, 6 declined participation in the 5year continuation study, and an additional 8 patients were excluded from analysis, leaving 233 patients from the
original randomized study. There were 133 cases included in the 5-year assessment (57% from the 8 sites).
Based on a denominator of 375 patients originally enrolled in the IDE trial, this report represents 30% of the study
population. Given the limitations of the original RCT and the 50% to 70% loss to follow-up, results from the 5-year
follow-up cannot be interpreted.
Observational Studies
Mean 17.3 year (range, 14.5-19.2) follow-up was reported for Charité types I-III intervertebral discs from the
Charité hospital. (13) For the 53 of 71 patients (75%) who were available for clinical and radiologic examination,
there were 16 type I discs (1984-1985), 25 type II discs (1985-1987), and 22 type III discs (1987-1989). Clinical
evaluation at follow-up showed no significant difference between the 3 types of discs for the Oswestry disability
index (ODI), visual analog scale (VAS) for pain, or overall outcome score. Of the 53 patients, 12 (23%) had a
segmental fusion during follow-up due to implant failure or pain. Seven of the 12 (58%) were due to implant
fractures, and 5 underwent secondary operative instrumented fusion. of the remaining 41 patients, 9 (17% of 53)
showed no signs of heterotopic ossification or ankylosis at follow-up, while ankylosis was observed in 32 patients
(60%) after 17 years. No signs of adjacent segment degeneration were found in the 9 cases (17%) without signs
of ankylosis, fusion, or implant failure. Although no adjacent segment degeneration was observed in the small
percentage of implants that remained functional (17%), these patients were significantly less satisfied than those
with spontaneous ankylosis based on the ODI (52 vs. 38) and VAS (6.1 vs. 4.5). The authors, who had designed
the prosthesis, concluded that this study demonstrated dissatisfying results after artificial disc replacement in
most of the evaluated cases regarding clinical, as well as radiologic outcomes.
Long-term follow-up in a larger number of patients is needed to answer questions regarding the potential for
device failure, decay, wear, and facet degeneration.
Kineflex-L Versus Charité
The pivotal study for the Kineflex artificial disc was a RCT that compared the Kineflex-L with an artificial disc
(Charité) that was already approved for sale. (14) There were 261 patients in the Kineflex group and 196 patients
in the Charité 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 Charité group. There were no significant differences between the Kineflex-L and Charité 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 Charité 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. (15)
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.16 The 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 the 2 device removals due to lymphocytic reaction) and 11.6% for the Charité group. Interpretation of
the 5-year results is limited by the high loss to follow-up.
An FDA advisory committee meeting on the Kineflex lumbar disc was scheduled for July 2013 but was cancelled
without explanation.
ProDisc-L® Controlled Trials
The pivotal study for the ProDisc®-L was an unblinded RCT of 242 patients followed up for 24 months.(3, 4)
Patients were originally randomized in a 2:1 ratio to ProDisc®-L artificial disc replacement (n=161) or
circumferential fusion (n=75). Using an FDA-requested composite measure of outcome that incorporated
symptom improvement and absence of complications, the ProDisc®-L had a success rate of 53.4% and fusion
had a success rate of 40.8%. This met prespecified criteria for a noninferiority margin of 10% and just achieved
statistical significance for a 1-sided statistical test of superiority with a p of 0.044. The calculations were based on
between 88% and 91% of randomized patients—how or which patients were censored was not described. Twoyear results from this trial were published in 2007, and 5-year follow-up was reported in 2012. (17-19) The
published 24-month report included 236 patients but did not provide information about the number of patients lost
to follow-up. The report included alternative definitions of overall success, which resulted in a greater difference
between the two groups (experimental group 63.5%, control group 45.1%, p=0.005). Of an original 236 patients
randomized, 186 (79%) were included in the 5-year follow-up of clinical outcomes (134 ProDisc-L® and 52
controls) and 166 (70%) (123 ProDisc-L® and 43 controls) were included for radiographic outcomes. Results
showed noninferiority, but not superiority of artificial disc replacement, with 53.7% of ProDisc-L® patients and
50.0% of fusion patients achieving overall success at 5 years. This change in overall success in ProDisc-L®
patients between 2 and 5 years (63.5%-53.7%, respectively) 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. On post-hoc analysis of
radiographs, adjacent level degeneration was observed in fewer ProDisc-L® patients (9.2% vs. 28.6%,
respectively). Adjacent level reoperations were not significantly different (1.9% ProDisc-L® and 4% controls).
There were 6 (3.7%) ProDisc-L® device failures.
Several of the individual components of the primary outcome measure were also statistically better in the ProDiscL® group at 2 years, but were no longer significantly different at 5 years. For example, at 5 years ODI scores
improved by 15% or more in 78.6% of ProDisc-L® patients compared with 76.5% of controls. A similar percentage
of patients maintained or improved SF-36 physical component Summary scores compared with baseline (81.3%
ProDisc-L® and 74.0% fusion), and overall neurologic success was obtained in 88.8% of ProDisc-L® patients and
89.6% of fusion patients. Secondary surgeries at the index level occurred in 8% of ProDisc-L® patients and 12%
of fusion patients (p not reported). Device success, defined as the absence of any reoperation required to modify
or remove implants and no need for supplemental fixation, was achieved in 96.3% of ProDisc-L® patients and
97.3% of fusion patients. Analysis of VAS scores for pain excluded patients who had secondary surgical
interventions (11 ProDisc-L® and 5 fusion). For the ProDisc-L® group, VAS improved from a mean of 75.9 at
baseline to 37.1 at 5 years. Mean VAS for the fusion group improved from 74.9 at baseline to 40.0 at 5 years.
There was no significant difference in VAS between the groups. Narcotic use decreased from a baseline of 84%
to 44.6% in ProDisc-L® patients and from 76% to 42.5% in fusion patients.
The ProDisc-L® for 2-level lumbar degenerative disease was reported in 2011 from a multicenter randomized
FDA-regulated non-inferiority trial.(20) All patients in the study had DDD at 2 contiguous vertebral levels from L3
to S1 with or without leg pain, a minimum of 6 months of conservative therapy, and a minimum ODI score of 40 or
higher. A total of 237 patients were treated in a 2:1 ratio with total disc arthroplasty or open circumferential
arthrodesis (performed through both anterior and posterior open incisions). Postoperative evaluations were
performed at 6 weeks and at 3, 6, 12, 18, and 24 months postoperatively. The total disc replacement group had
decreased operative times (160.2 vs. 272.8 min), estimated blood loss (398.1 vs. 569.3 mL), and length of
hospital stay (3.8 vs. 5.0 days). At 24 months, 58.8% patients in the ProDisc-L® group and 47.8% patients in the
arthrodesis group achieved the criteria for success, demonstrating non-inferiority but not superiority. The ProDiscL® group showed significant benefit in percentage improvement in the ODI (52.4% vs. 40.9%), a greater
percentage of patients who achieved 15-point or more improvement in the ODI (73.2% vs. 59.7%), the SF-36
physical component summary score (43.9 vs. 39.2), and 6-month neurologic success (87.3% vs. 71.6%). A
greater percentage of patients in the arthrodesis group required secondary surgical procedures (8.3% vs. 2.4%).
As noted in an accompanying commentary, there are a number of limitations to this study. Comparison with a
procedure (open 360° fusion) that is not the criterion standard precludes decisions on the comparative efficacy of
this procedure to the standard of care. Other limitations include the relatively short follow-up and lack of blinding
of both patients and providers.(21)
activL compared with ProDisc-L or Charité
Two-year outcomes from the multicenter IDE trial of the activL artificial intervertebral disc were reported by Garcia
et al in 2015.22 In this patient-blinded non-inferiority trial, patients with DDD at either 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 endpoint (a ≥ 15 point improvement on the ODI, maintenance or improvement in
neurological status, maintenance or improvement in range of motion at the index level, freedom from additional
surgery at the index level, and freedom from serious device-related adverse events), activL was both non-inferior
(p<0.001) and superior (p=0.02) to the control group. Intention-to-treat analysis of secondary outcome measures
showed similar improvements in back pain (74% vs 68%), ODI (75.2% vs 66.0%), device success (84.4% vs
84.9%), surgical re-intervention (2.3% vs 1.9%), and patient satisfaction scores for the 2 groups (94.1% activL vs
93.1% control, 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 compared to the ProDisc-L and Charité controls (59% vs. 43%, p<0.01).
Maverick™
The Maverick™ disc is not marketed in the United States.
In 2011, Gornet et al. reported 24-month results from an FDA-regulated multicenter IDE randomized nonblinded
trial of the metal-on-metal Maverick artificial disc. (23) A total of 577 patients were randomized in a 2:1 ratio to the
Maverick disc (n=405) or to anterior interbody fusion with INFUSE Bone Graft and tapered fusion cages (n=172).
All patients underwent a single-level, open anterior surgical procedure between the L4 and S1 level. The Maverick
group had longer surgical times (1.8 vs. 1.4 hours) and greater blood loss (240.7 vs. 95.2 mL). Hospitalization
stays were similar for both groups (2.2 vs. 2.3 days for fusion). At 24 months, radiographic fusion was observed in
100% of the control patients. Heterotopic ossification was observed in 2.6% of patients with the artificial disc.
The FDA-defined measure of overall success was a combination of a successful outcome in ODI, neurologic
status, disc height, no additional surgery classified as failure, and no serious device or device/surgical procedurerelated adverse events at the 24-month follow-up. Patients who received the Maverick artificial disc had superior
outcomes in overall success (73.5% vs. 55.3%) and in the component scores of ODI success (82.2% vs. 74.6%
improved), back pain (improvement of 53.4 vs. 49 points), and SF-36 Physical Component Summary score (17.0
vs. 14.3). Leg pain scores did not differ between the 2 groups. Global perceived effect (“completely recovered” or
“much improved”) was higher in the Maverick group (78.1% vs. 67.4%). The Maverick group had fewer implant or
surgical procedure-related adverse events (1% vs. 7%), and return-to-work intervals were reduced (median, 75
vs. 96 days). The percentage of patients who were working at 24 months was similar (74.1% vs. 73.4%). There
were 2 implant removals in the Maverick group, one was considered to be related to an allergic reaction. Longer
follow-up with this 2-piece metal-on-metal implant is needed, particularly in light of emerging complications (e.g.,
pseudotumor formation) with metal-on-metal hip implants.
FlexiCore
Preliminary results on the FlexiCore® metal-on-metal intervertebral disc were presented in 2008 from 2 of the
sites involved in the investigational device trial.(24) Results were reported for 76 patients enrolled at the 2 sites (of
the entire study cohort of 401 patients) who had been randomly assigned with a ratio of 2:1 to either FlexiCore®
or fusion control; 9 subjects did not receive the index surgery, 44 patients were treated with the artificial disc, and
23 patients were treated with fusion. Compared with fusion, placement of the artificial disc was associated with
less blood loss (97 vs. 179 mL, respectively), reduced operating time (82 vs. 179 min, respectively), and reduced
length of hospital stay (2 vs. 3 days, respectively). ODI and VAS pain scores were not significantly different
between the groups. At 24 months, the ODI scores had decreased from 62 to 6 in the Flexicore® group and from
58 to 12 in the fusion group. VAS scores decreased from 86 to 16 in the FlexiCore® group and from 82 to 20 in
the fusion group. Eight patients in each group had complications requiring interventional surgery.
Other
In 2009, Berg et al. published 2-year follow-up of an RCT of 1- and 2- level total disc replacement. (9) Five-year
follow-up of patients in this study was reported in 2013. (25) Patients (n=152) with symptomatic DDD in 1 or 2
motion segments between L3 and S1, with lower back pain as a predominant symptom, were randomly assigned
to 1 of 3 total disc replacement devices available in Sweden (Charité, ProDisc®, or Maverick™, n=80) or to
instrumented fusion (posterolateral or posterior lumbar interbody fusion, n=72). The randomization was stratified
for number of levels, with 56% of total disc replacement patients having 1-level surgery compared with 46% of
fusion patients. Only patients who did not have a preference to the type of treatment were enrolled in the trial, and
they were informed of the result of randomization on arrival at the hospital for surgery. No patient left the study
when informed of the randomization. There was 100% follow-up at the 1- and 2-year assessments and 99.3%
follow-up at the 5-year assessment.The primary outcome, which does not appear to be a validated measure, was
a global assessment of back pain consisting of “total relief,” “much better,” “better,” “unchanged,” or “worse.” The
percentage of patients in the disc replacement group who reported being pain-free was 30% at the 1- and 2-year
follow-up, and 38% at 5-year follow-up. In the fusion group, 10% reported being pain-free at 1 year and 15%
reported being pain-free at 2 and 5 years. At 5 years, a similar percentage of patients reported being either totally
pain free or much better (72.5% for disc replacement, 66.7% for fusion). The total disc replacement group showed
lower mean VAS for pain at 1 and 2 years (25.4 vs. 29.2, respectively) and had better outcome scores on a
quality-of-life scale and ODI at 1 year (19.5 vs. 24.9, respectively) but not the 2-year follow-up (20.0 vs. 23.0,
respectively). At 5 years, the disc replacement group had modestly improved outcome scores for both VAS back
pain (23 vs. 31) and ODI (17 vs. 23). The most common cause of reoperation in the disc replacement group was
to fuse the index level that was believed to cause persistent or recurrent pain (5%).
The most common cause of reoperation in the fusion group was operation at an adjacent level (7%). Twenty-two
disc replacement patients underwent postoperative facet block due to remaining pain. Twenty fusion patients had
their instrumentation removed due to persistent or recurrent pain. The investigators found no association between
achievement of surgical goals (absence of mobility with fusion and maintenance of mobility with disc replacement)
and clinical outcomes at 2 years.(26)
Hybrid Procedures
In 2015, Hoff et al published an RCT with 62 patients that compared a hybrid procedure (anterior lumbar
interbody fusion at one level and a Maverick disc at another level) to 2-level circumferential fusion. (27) VAS for
pain was significantly lower by about 1/10 cm 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 the groups in the ODI.
Adjacent segment degeneration did not differ significantly between the 2 groups.
Longer Term Follow-Up
Siepe et al. in 2014 reported minimum 5-year follow-up for 181 patients implanted with the ProDisc II at their
institution. (28) 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 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, 3.3, p<0.000), although a slight deterioration (0.66 on a scale of 10) was observed between
48 and 120 months (p<0.05). 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 bisegmental disc replacement (p=0.031). The overall satisfaction rate was 89.1% for single-level and
69.0% for 2-level disc replacement.
Five-year results of lumbar disc arthroplasty from the Swiss Spine Registry were published in 2014. (29) Five
devices were used during the period of study (Activ L, Charité, Dynardi, Maverick, ProDisc-L). 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 (73 to 29) and leg pain (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%. Another case series was identified that followed
up 55 patients for an average of 8.7 years after disc replacement with the ProDisc-L; 60% of patients report an
excellent result. (30) Additional publications report on the implantation of artificial discs at 2 levels in the lumbar
spine.31
In 2015, Lu at al reported minimum 11-year follow-up on 32 of 35 patients implanted with the Charité III. (32) Out
of the 3 patients who were not included in this prospective study, 1 chose not to participate, 1 was lost to followup, and 1 died of unrelated causes. Prior to surgery, VAS for back pain was 8.5 and the ODI 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 to 13.8
years), VAS improved to 1.5 (p=0.0015), the ODI 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 underwent 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%. The authors proposed several possible reasons for the high success rate in this group of patients,
including strict selection criteria and the lighter weight of most Chinese compared to western patients, which
would lead to less load on the prosthesis.
Adverse Events
Complications with artificial lumbar discs are emerging with longer-term follow-up. One study from Asia reported
that clinical outcomes of both the Charité and the ProDisc were fairly good, but the facet joint of the index level
and the disc at the adjacent level showed an aggravation of the degenerative process in a significant number of
patients, regardless of the device used. (33) Another study reported that progression of facet degeneration (29%
of levels replaced with the ProDisc II) was associated with female sex, malposition of the prosthesis on the frontal
plane, and 2-level total disc replacement. (35) Analysis of postoperative pain patterns in 58 patients of 175 (33%)
implanted with the ProDisc II showed facet joint pain in 22 (13%) and sacroiliac joint pain in 21 (12%). (35)
Another report describes late complications in 75 patients who had received an earlier generation SB Charité
prosthesis. (36) As all of the patients had been originally treated by other surgeons, the percentage of implant
failure cannot be determined from this report. The mean interval between insertion and retrieval of the prosthesis
was 8 years and 11 months (range, 3-16 years). The most frequent complications included subsidence (n=39),
disc prosthesis too small (n=24), adjacent disc degeneration (n=36), degenerative scoliosis (n=11), facet joint
degeneration (n=25), and metal wire breakage (n=10). The report indicated that good placement and good sizing
of the disc prosthesis appeared problematic for many of the patients, adjacent-disc degeneration was seen in
many patients, and polyethylene wear with inflammatory fibrous tissue containing wear debris was observed. The
report concluded that wear mechanisms of 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 prosthesis can
be difficult and dangerous. Therefore, long-term health outcomes following disc implantation in young active
patients may become a clinically significant issue.
In 2011, Guyer et al. reported 4 cases of a lymphocytic reaction to a metal-on-metal artificial disc (1 Kineflex-C
cervical disc, 2 Kineflex-L lumbar discs, 1 Maverick lumbar disc) that required revision. (15) The mode of failure
was determined to be compression of neural tissue or other adjacent structures by a soft-tissue mass. Three
patients had a good outcome after the explantation and revision surgery; 1 patient continued to have residual
symptoms related to the neural compression caused by the mass. Two other cases of a granulomatous mass
(pseudotumor) with the metal-on-metal Maverick prosthesis have been reported. (37,38) One caused iliac vein
occlusion and spinal stenosis; the second resulted in spinal compression and paraplegia.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 1.
Table 1. Summary of Key Trials
NCT No.
Ongoing
NCT 02381574
Unpublished
NCT01704677
Trial Name
Planned Enrollment
Completion Date
French Lumbar Total Disk
Replacement
Observational Study
(FLTDR Observational
Study)
600
Dec 2020
Lumbar Disc Prosthesis
Versus Multidisciplinary
Rehabilitation in Chronic
Back Pain and Localized
Degenerative Disc. Long
Term Follow-up of a
Randomized Multicentre
Trial
151
Nov 2015
NCT: national clinical trial.
Summary of Evidence
The evidence for the lumbar artificial intervertebral disc in individuals who have degenerative disc disease
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. The Charité has
been withdrawn from the market, and its successor, the INMOTION, is not marketed in the United States. The 5year results of the ProDisc-L randomized controlled trial provide evidence for the noninferiority of artificial disc
replacement. Superiority of ProDisc-L with circumferential fusion was achieved at 2, but not 5 years in this
unblinded trial. At this time, the potential benefits of the artificial disc, such as faster recovery or reduced adjacentlevel disc degeneration, have not been demonstrated. In addition, considerable uncertainty remains about
whether response rates will continue to decline over longer time periods and long-term complications with these
implants will emerge.
Some randomized trials have concluded that this technology is noninferior to fusion, but outcomes that would
make noninferiority sufficient to demonstrate the clinical benefit of the artificial lumbar disc have not been
established. The evidence is insufficient to determine the effects of the technology on health outcomes.
Clinical Input Received From Physician Specialty Societies and Academic Medical
Centers
While the various physician specialty societies and academic medical centers may collaborate with and make
recommendations during this process, through the provision of appropriate reviewers, input received does not
represent an endorsement or position statement by the physician specialty societies or academic medical centers,
unless otherwise noted.
In response to requests, input was received from 1 physician specialty society and 3 academic medical centers
while this policy was under review in 2008. The 4 reviewers disagreed with the policy statement that artificial
intervertebral discs for the lumbar spine are investigational.
After consideration of the clinical input in 2008, it was concluded that due to limitations of the only 2 available
RCTs (described herein), combined with the marginal benefit compared with fusion, evidence is insufficient to
determine whether artificial lumber discs are beneficial in the short term. In addition, serious questions remain
about potential long-term complications with these implants.
Practice Guidelines and Position Statements
North American Spine Society
The North American Spine Society issued 2014 coverage recommendations for lumbar artificial disc replacement.
(9) The following recommendation was made: Lumbar artificial disc replacement is indicated as an alternative to
lumbar fusion for patients with discogenic low back pain who meet all of the following criteria from the Lumbar
Fusion Recommendation:
 Advanced single-level disease noted on an MRI [magnetic resonance image] and plain radiographs of
the lumbar spine at L4-5 or L5-1, characterized by moderate to severe degeneration of the disc with
Modic changes (defined as a peridiscal bone signal above and below the disc space in question) as
compared to other normal or mildly degenerative level (characterized by normal plain radiographic
appearance and no or mild degeneration on MRI)
 Presence of symptoms for at least one year and that are not responsive to multi-modal nonoperative
treatment over that period that should include physical therapy/rehabilitation program but may also
include (but not limited to) pain management, injections, cognitive behavior therapy, and active exercise
programs
 Absence of active significant psychiatric disorders, such as major depression, requiring pharmaceutical
treatment
 Primary complaint of axial pain, with a possible secondary complaint of lower extremity pain
 Age 18 to 60 years old (unique to disc replacement, not fusion)
 Absence of significant facet arthropathy at the operative level (unique to disc replacement, not fusion)
Contraindications included multi-level degeneration, facet arthropathy, and hybrid procedures (ie, in combination
with a spinal fusion or other stabilizing-type procedure).
International Society for the Advancement of Spine Surgery
In 2015, the International Society for the Advancement of Spine Surgery (IASS) published a policy statement on
the lumbar artificial disc.(40) The goal of the policy statement was “to educate patients, physicians, medical
providers, reviewers, adjustors, case managers, and all others involved or affected by insurance coverage
decisions regarding lumbar disc replacement surgery.” The authors of the policy statement were selected for their
expertise and experience with the artificial lumbar disc and included one of the investigators for the Prodisc-L IDE
trial and another for the ActivL IDE trial. RCT and long-term results that were favorable to the LADR were
discussed.
American Pain Society
In 2009, the American Pain Society’s (APS) practice guidelines provided a recommendation of “insufficient
evidence” to adequately evaluate long-term benefits and harms of vertebral disc replacement.(41) The guideline
was based on a systematic review commissioned by APS and conducted by the Oregon Evidence-Based Practice
Center.(42) The rationale for the recommendation was that although artificial disc replacement has been
associated with similar outcomes compared with fusion, the trial results were only applicable to a narrowly defined
subset of patients with single-level degenerative disease, and the type of fusion surgery in the trials is no longer
widely used due to frequent poor outcomes. In addition, all trials had been industry-funded, and data on long-term
(beyond 2 years) benefits and harms following artificial disc replacement were limited.
National Institute for Health and Clinical Excellence
Guidance in 2004 from the United Kingdom’s National Institute for Health and Clinical Excellence (NICE)
concluded that evidence on the safety and efficacy of prosthetic intervertebral disc replacement in the lumbar
spine appeared adequate to support the use of this procedure with audit and review; however, there was little
evidence on outcomes beyond 2 to 3 years.(43) In 2009, NICE updated the guidance on this procedure with
studies reporting 13-year follow-up but with most of the evidence from studies with shorter durations of followup.(44) NICE concluded that evidence appeared adequate to support the use of this procedure, provided that
normal arrangements are in place for clinical governance, consent, and audit. Clinicians were encouraged to
continue to collect and publish data on longer-term outcomes, including information about patient selection and
the need for further surgery.
U.S. Preventive Services Task Force Recommendations
Not applicable.
Medicare National Coverage
Effective for services performed from May 16 through August 13, 2007, the Centers for Medicare and Medicaid
Services (CMS) found that lumbar artificial disc replacement (LADR) with the Charité® lumbar artificial disc is not
reasonable and necessary for the Medicare population older than 60 years of age. Therefore, CMS issued a
national noncoverage determination for LADR with the Charité® lumbar artificial disc for the Medicare population
older than 60 years of age.(45)
Effective for services performed on or after August 14, 2007, CMS found that LADR is not reasonable and
necessary for the Medicare population older than 60 years of age; therefore, LADR is noncovered for Medicare
beneficiaries older than 60 years of age. For Medicare beneficiaries 60 years of age and younger, there is no
national coverage determination (NCD), leaving such determinations to be made by the local contractors.
The NCD was revised in 2007 to reflect a change from noncoverage for a specific implant (the Charité®), to
noncoverage for the lumbar artificial disc replacement procedure for the Medicare population older than 60 years
of age. (46) CMS provided this explanation, “The original NCD for LADR was focused on a specific lumbar
artificial disc implant (Charité™) because it was the only one with FDA approval at that time. In the original
decision memorandum for LADR, CMS stated that when another lumbar artificial disc received FDA approval
CMS would reconsider the policy. Subsequently, another lumbar artificial disc, ProDisc®-L, received FDA
approval, which initiated the reconsideration of the NCD on LADR. After reviewing the evidence, CMS is
convinced that indications for the procedure of LADR exclude the populations older than age 60; therefore, the
revised NCD addresses the procedure of LADR rather than LADR with a specific manufacture’s implant.” (47)
References
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10. Guyer RD, McAfee PC, Banco RJ, et al. Prospective, randomized, multicenter Food and Drug
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11. Jacobs W, Van der Gaag NA, Tuschel A, et al. Total disc replacement for chronic back pain in the
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12. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Artificial lumbar disc
arthroplasty. TEC Assessments. 2013;Volume 28, Tab 7.
13. Putzier M, Funk JF, Schneider SV, et al. Charite total disc replacement--clinical and radiographical
results after an average follow-up of 17 years. Eur Spine J. Feb 2006; 15(2):183-195. PMID 16254716
14. Guyer RD, Pettine K, Roh JS, et al. Comparison of 2 lumbar total disc replacements: results of a
prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month followup. Spine (Phila Pa 1976). May 20 2014;39(12):925-931. PMID 24718066
15. Guyer RD, Shellock J, MacLennan B, et al. Early failure of metal-on-metal artificial disc prostheses
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17. Zigler J, Delamarter R, Spivak JM, et al. Results of the prospective, randomized, multicenter Food and
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1976). May 15 2007;32(11):1155-1162; discussion 1163. PMID 17495770
18. Zigler JE, Delamarter RB. Five-year results of the prospective, randomized, multicenter, Food and Drug
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Spine. Dec 2012;17(6):493-501. PMID 23082846
19. Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with
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fusion. J Neurosurg Spine. Dec 2012;17(6):504-511. PMID 23082849
20. Delamarter R, Zigler JE, Balderston RA, et al. Prospective, randomized, multicenter Food and Drug
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with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: results
at twenty-four months. J Bone Joint Surg Am. Apr 20 2011;93(8):705-715. PMID 21398574
21. Schoenfeld AJ. Commentary on an article by Rick Delamarter, MD, et al.: "Prospective, randomized,
multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total
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lumbar disc disease. Results at twenty-four months". J Bone Joint Surg Am. Apr 20 2011;93(8):e41.
PMID 21398573
22. Garcia R, Jr., Yue JJ, Blumenthal S, et al. Lumbar total disc replacement for discogenic low back pain:
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23. Gornet MF, Burkus JK, Dryer RF, et al. Lumbar disc arthroplasty with MAVERICK disc versus standalone interbody fusion: a prospective, randomized, controlled, multicenter investigational device
exemption trial. Spine (Phila Pa 1976). Dec 1 2011;36(25):E1600-1611. PMID 21415812
24. Sasso RC, Foulk DM, Hahn M. Prospective, randomized trial of metal-on-metal artificial lumbar disc
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25. Skold C, Tropp H, Berg S. Five-year follow-up of total disc replacement compared to fusion: a
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26. Berg S, Tropp HT, Leivseth G. Disc height and motion patterns in the lumbar spine in patients operated
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27. Hoff EK, Strube P, Pumberger M, et al. ALIF and total disc replacement versus 2-level circumferential
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28. Siepe CJ, Heider F, Wiechert K, et al. Mid- to long-term results of total lumbar disc replacement: a
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29. Aghayev E, Etter C, Barlocher C, et al. Five-year results of lumbar disc prostheses in the SWISSspine
registry. Eur Spine J. Oct 2014;23(10):2114-2126. PMID 24947182
30. Tropiano P, Huang RC, Girardi FP, et al. Lumbar total disc replacement. Seven to eleven-year follow-up.
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31. Hannibal M, Thomas DJ, Low J, et al. ProDisc-L total disc replacement: a comparison of 1-level versus
2-level arthroplasty patients with a minimum 2-year follow-up. Spine (Phila Pa 1976). Oct 1
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32. Lu SB, Hai Y, Kong C, et al. An 11-year minimum follow-up of the Charite III lumbar disc replacement for
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33. Shim CS, Lee SH, Shin HD, et al. CHARITE versus ProDisc: a comparative study of a minimum 3-year
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34. Park CK, Ryu KS, Jee WH. Degenerative changes of discs and facet joints in lumbar total disc
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2008;33(16):1755-1761. PMID 18580548
35. Siepe CJ, Korge A, Grochulla F, et al. Analysis of post-operative pain patterns following total lumbar disc
replacement: results from fluoroscopically guided spine infiltrations. Eur Spine J. Jan 2008;17(1):44-56.
PMID 17972116
36. Punt IM, Visser VM, van Rhijn LW, et al. Complications and reoperations of the SB Charite lumbar disc
prosthesis: experience in 75 patients. Eur Spine J. Jan 2008;17(1):36-43. PMID 17929065
37. Berry MR, Peterson BG, Alander DH. A granulomatous mass surrounding a Maverick total disc
replacement causing iliac vein occlusion and spinal stenosis: a case report. J Bone Joint Surg Am. May
2010;92(5):1242-1245. PMID 20439671
38. Cabraja M, Schmeding M, Koch A, et al. Delayed formation of a devastating granulomatous process
after metal-on-metal lumbar disc arthroplasty. Spine (Phila Pa 1976). Jun 1 2012;37(13):E809-813.
PMID 22089396
39. North American Spine Society (NASS). NASS policy coverage recommendations: Lumbar Artificial Disc
Replacement. 2014; https://www.spine.org . Accessed May 2016.
40. Zigler J, Garcia R. ISASS Policy Statement - Lumbar Artificial Disc. Int J Spine Surg. 2015;9:7. PMID
25785243
41. Chou R, Loeser JD, Owens DK, et al. Interventional therapies, surgery, and interdisciplinary
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Society. Spine (Phila Pa 1976). May 1 2009;34(10):1066-1077. PMID 19363457
42. Chou R, Baisden J, Carragee EJ, et al. Surgery for low back pain: a review of the evidence for an
American Pain Society Clinical Practice Guideline. Spine (Phila Pa 1976). May 1 2009;34(10):10941109. PMID 19363455
43. National Institute for Health and Clinical Excellence (NICE). Prosthetic intervertebral disc replacement. IP
Guidance Number: IPG100. 2004.
44. National Institute for Health and Clinical Excellence (NICE). Prosthetic intervertebral disc replacement in
the lumbar spine (IPG306). 2009; http://www.nice.org.uk/nicemedia/pdf/IPG306Guidance.pdf . Accessed
May 2016.
45. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for
LUMBAR ARTIFICIAL DISC Replacement (LADR) (150.10). 2007; https://www.cms.gov/medicarecoverage-database/details/ncddetails.aspx?NCDId=313&ncdver=2&CoverageSelection=National&KeyWord=lumbar+artificial+disc&Key
WordLookUp=Title&KeyWordSearchType=And&id=170&bc=gAAAABAAAAAA& . Accessed May 2016
46. Centers for Medicare and Medicaid Services (CMS). Change request 5727, CMS Manual system.
September 11, 2007; http://www.cms.hhs.gov/Transmittals/Downloads/R75NCD.pdf . Accessed May
2016.
47. Centers for Medicare and Medicaid Services (CMS). Medicare Learning Network Matters. 2007;
http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5727.pdf . Accessed May 2016.
Appendix
[TOP]
N/A
History
[TOP]
Date
08/12/03
01/01/04
05/10/05
04/21/06
07/11/06
09/12/06
Reason
Add to Surgery Section - New policy. Hold for notification, effective date December 15, 2003.
Replace policy - CPT code updates only.
Replace policy - Policy updated with February 2005 TEC Assessment; references added; policy
statement unchanged.
Codes Updated - No other changes
Replace policy - Policy updated with Medicare noncoverage decision; policy statement unchanged;
reference added.
Replace policy - Updated Description and Benefit Application sections to include information on
01/26/07
02/26/07
03/13/07
04/10/07
08/14/07
02/12/08
01/13/09
12/08/09
09/14/10
12/14/10
12/16/11
11/27/12
01/10/13
04/17/13
09/30/13
12/09/13
03/25/14
08/12/14
01/08/15
06/09/15
08/11/15
06/14/16
FDA approval of ProDisk L. No other changes.
Codes Updated - No other changes.
Update Codes - No other changes.
Replace policy - Title expanded for clarification with the addition of “Lumbar Spine”; cross reference
added.
Cross Reference Update - No other changes.
Replace policy - Policy updated with 2007 TEC Assessment; new reference added. Policy
statement unchanged.
Replace policy - Policy updated with literature review; no change in policy statement. References
added.
Replace policy - Policy updated with literature search; no change to the policy statement. Rationale
section extensively revised references and codes added.
Replace policy - Policy updated with literature search; no change to the policy statement.
References added.
Cross Reference Update - No other changes.
Replace policy - Policy updated with literature search through August 2010. References have been
added and reordered; the policy statement remains unchanged.
Replace policy – Policy updated with literature search through August 2011; Rationale section
revised; references 11 and 14 added and references reordered; policy statement unchanged.
Replace policy - Rationale section revised based on literature review through June 2012.
References 12, 14,19,20,23 29 added; others renumbered. Policy statement unchanged.
Coding update. CPT code 22586, effective 1/1/13, added to policy.
Update Related Policies – Add 7.01.542.
Update Related Policies. Change title to 7.01.120.
Replace policy. Rationale section updated. Added references 8,9,11,12,13,23,31,32. No change to
policy statement. CPT codes 63030 and 63035 removed from policy; these do not apply.
Replace policy. Policy updated with literature search through October, 2013. References 12, 16, 17
and 24 added; others renumbered/removed. Policy statement unchanged. ICD-9 diagnosis and
ICD-10-CM codes removed from the policy; these are not utilized in adjudication.
Update Related Policies. Change title to 7.01.542.
Update Related Policies. Add 7.01.551.
Coding update. ICD-10-PCS codes added to support remediation efforts.
Annual Review. Policy updated with literature review through November 25, 2014; references 15,
27-28, and 37 added; policy statement unchanged.
Policy updated with literature review through February 9, 2016; references 16, 22, 27, 32, and 3940 added. Policy statement unchanged.
Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts
policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical
technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in
their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific
medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
©2016 Premera All Rights Reserved.
Discrimination is Against the Law
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does not discriminate on the basis of race, color, national origin, age,
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disability, or sex, you can file a grievance with:
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PO Box 91102, Seattle, WA 98111
Toll free 855-332-4535, Fax 425-918-5592, TTY 800-842-5357
Email AppealsDepartmentInquiries@Premera.com
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Call 800-722-1471 (TTY: 800-842-5357).
አማሪኛ (Amharic):
ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue
Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ።
የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ
ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት
አለዎት።በስልክ ቁጥር 800-722-1471 (TTY: 800-842-5357) ይደውሉ።
‫( العربية‬Arabic):
‫ قد يحوي ھذا اإلشعار معلومات مھمة بخصوص طلبك أو‬.‫يحوي ھذا اإلشعار معلومات ھامة‬
‫ قد تكون ھناك تواريخ مھمة‬.Premera Blue Cross ‫التغطية التي تريد الحصول عليھا من خالل‬
‫ وقد تحتاج التخاذ إجراء في تواريخ معينة للحفاظ على تغطيتك الصحية أو للمساعدة‬.‫في ھذا اإلشعار‬
‫ اتصل‬.‫ يحق لك الحصول على ھذه المعلومات والمساعدة بلغتك دون تكبد أية تكلفة‬.‫في دفع التكاليف‬
800-722-1471 (TTY: 800-842-5357)‫بـ‬
中文 (Chinese):
本通知有重要的訊息。本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息。本通知內可能有重要日期。您可能需要在截止日期
之前採取行動，以保留您的健康保險或者費用補貼。您有權利免費以您的母
語得到本訊息和幫助。請撥電話 800-722-1471 (TTY: 800-842-5357)。
037338 (07-2016)
Oromoo (Cushite):
Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa
yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee
odeeffannoo barbaachisaa qabaachuu danda’a. Guyyaawwan murteessaa
ta’an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf
yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan
jiraachuu danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin
odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu.
Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa.
Français (French):
Cet avis a d'importantes informations. Cet avis peut avoir d'importantes
informations sur votre demande ou la couverture par l'intermédiaire de
Premera Blue Cross. Le présent avis peut contenir des dates clés. Vous
devrez peut-être prendre des mesures par certains délais pour maintenir
votre couverture de santé ou d'aide avec les coûts. Vous avez le droit
d'obtenir cette information et de l’aide dans votre langue à aucun coût.
Appelez le 800-722-1471 (TTY: 800-842-5357).
Kreyòl ayisyen (Creole):
Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen
enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti
asirans lan atravè Premera Blue Cross. Kapab genyen dat ki enpòtan nan
avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka
kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo.
Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a,
san ou pa gen pou peye pou sa. Rele nan 800-722-1471
(TTY: 800-842-5357).
Deutsche (German):
Diese Benachrichtigung enthält wichtige Informationen. Diese
Benachrichtigung enthält unter Umständen wichtige Informationen
bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera
Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser
Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln
müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten
zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in
Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471
(TTY: 800-842-5357).
Hmoob (Hmong):
Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum
tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv
thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue
Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv
no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub
dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj
yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob
ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau
ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471
(TTY: 800-842-5357).
Iloko (Ilocano):
Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a
pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion
maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue
Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar.
Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti
partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti
salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti
daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti
bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357).
Italiano (Italian):
Questo avviso contiene informazioni importanti. Questo avviso può contenere
informazioni importanti sulla tua domanda o copertura attraverso Premera
Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe
essere necessario un tuo intervento entro una scadenza determinata per
consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di
ottenere queste informazioni e assistenza nella tua lingua gratuitamente.
Chiama 800-722-1471 (TTY: 800-842-5357).
日本語 (Japanese):
この通知には重要な情報が含まれています。この通知には、Premera Blue
Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
ります。この通知に記載されている可能性がある重要な日付をご確認くだ
さい。健康保険や有料サポートを維持するには、特定の期日までに行動を
取らなければならない場合があります。ご希望の言語による情報とサポー
トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話
ください。
Română (Romanian):
Prezenta notificare conține informații importante. Această notificare
poate conține informații importante privind cererea sau acoperirea asigurării
dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie
în această notificare. Este posibil să fie nevoie să acționați până la anumite
termene limită pentru a vă menține acoperirea asigurării de sănătate sau
asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste
informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471
(TTY: 800-842-5357).
한국어 (Korean):
본 통지서에는 중요한 정보가 들어 있습니다. 즉 이 통지서는 귀하의 신청에
관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를
포함하고 있을 수 있습니다. 본 통지서에는 핵심이 되는 날짜들이 있을 수
있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기
위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다.
귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는
권리가 있습니다. 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오.
Pусский (Russian):
Настоящее уведомление содержит важную информацию. Это
уведомление может содержать важную информацию о вашем
заявлении или страховом покрытии через Premera Blue Cross. В
настоящем уведомлении могут быть указаны ключевые даты. Вам,
возможно, потребуется принять меры к определенным предельным
срокам для сохранения страхового покрытия или помощи с расходами.
Вы имеете право на бесплатное получение этой информации и
помощь на вашем языке. Звоните по телефону 800-722-1471
(TTY: 800-842-5357).
ລາວ (Lao):
ແຈ້ ງການນ້ີ ມີຂ້ໍ ມູ ນສໍາຄັ ນ. ແຈ້ ງການນ້ີ ອາດຈະມີຂ້ໍ ມູ ນສໍາຄັ ນກ່ ຽວກັ ບຄໍາຮ້ ອງສະ
ໝັ ກ ຫື ຼ ຄວາມຄຸ້ ມຄອງປະກັ ນໄພຂອງທ່ ານຜ່ ານ Premera Blue Cross. ອາດຈະມີ
ວັ ນທີສໍາຄັ ນໃນແຈ້ ງການນີ້. ທ່ ານອາດຈະຈໍາເປັນຕ້ ອງດໍາເນີນການຕາມກໍານົ ດ
ເວລາສະເພາະເພື່ອຮັ ກສາຄວາມຄຸ້ ມຄອງປະກັ ນສຸ ຂະພາບ ຫື ຼ ຄວາມຊ່ ວຍເຫື ຼ ອເລື່ອງ
ຄ່ າໃຊ້ ຈ່ າຍຂອງທ່ ານໄວ້ . ທ່ ານມີສິດໄດ້ ຮັ ບຂ້ໍ ມູ ນນ້ີ ແລະ ຄວາມຊ່ ວຍເຫື ຼ ອເປັນພາສາ
ຂອງທ່ ານໂດຍບໍ່ເສຍຄ່ າ. ໃຫ້ ໂທຫາ 800-722-1471 (TTY: 800-842-5357).
ភាសាែខម រ (Khmer):
េសចកត ីជូនដំណឹងេនះមានព័ត៌មានយា៉ងសំខាន់។ េសចកត ីជូនដំណឹងេនះរបែហល
ជាមានព័ត៌មានយា៉ងសំខាន់អំពីទរមង់ែបបបទ ឬការរា៉ប់រងរបស់អនកតាមរយៈ
Premera Blue Cross ។ របែហលជាមាន កាលបរ ិេចឆ ទសំខាន់េនៅកនុងេសចកត ីជូន
ដំណឹងេនះ។ អន ករបែហលជារតូវការបេញច ញសមតថ ភាព ដល់កំណត់ៃថង ជាក់ចបាស់
នានា េដើមបីនឹងរកសាទុកការធានារា៉ប់រងសុខភាពរបស់អនក ឬរបាក់ជំនួយេចញៃថល ។
អន កមានសិទធិទទួ លព័ត៌មានេនះ និងជំនួយេនៅកនុងភាសារបស់អនកេដាយមិនអស
លុយេឡើយ។ សូ មទូ រស័ពទ 800-722-1471 (TTY: 800-842-5357)។
ਪੰ ਜਾਬੀ (Punjabi):
ਇਸ ਨੋਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ
ਕਵਰੇਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹੱ ਤਵਪੂਰਨ ਜਾਣਕਾਰੀ ਹੋ ਸਕਦੀ ਹੈ . ਇਸ ਨੋਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ
ਹੋ ਸਕਦੀਆਂ ਹਨ. ਜੇਕਰ ਤੁਸੀ ਜਸਹਤ ਕਵਰੇਜ ਿਰੱ ਖਣੀ ਹੋਵੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ
ਇਛੁੱ ਕ ਹੋ ਤਾਂ ਤੁਹਾਨੂੰ ਅੰ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੁੱ ਕਣ ਦੀ ਲੋ ੜ ਹੋ ਸਕਦੀ ਹੈ ,ਤੁਹਾਨੂੰ
ਮੁਫ਼ਤ ਿਵੱ ਚ ਤੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ਮਦਦ ਪ੍ਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ
800-722-1471 (TTY: 800-842-5357).
‫( فارسی‬Farsi):
‫اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم‬. ‫اين اعالميه حاوی اطالعات مھم ميباشد‬
‫ به تاريخ ھای مھم در‬.‫ باشد‬Premera Blue Cross ‫تقاضا و يا پوشش بيمه ای شما از طريق‬
‫شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه‬. ‫اين اعالميه توجه نماييد‬
‫شما حق‬. ‫ به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد‬،‫ھای درمانی تان‬
‫ برای کسب‬.‫اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد‬
‫( تماس‬800-842-5357 ‫ تماس باشماره‬TTY ‫ )کاربران‬800-722-1471 ‫اطالعات با شماره‬
.‫برقرار نماييد‬
Polskie (Polish):
To ogłoszenie może zawierać ważne informacje. To ogłoszenie może
zawierać ważne informacje odnośnie Państwa wniosku lub zakresu
świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na
kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie
przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub
pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej
informacji we własnym języku. Zadzwońcie pod 800-722-1471
(TTY: 800-842-5357).
Português (Portuguese):
Este aviso contém informações importantes. Este aviso poderá conter
informações importantes a respeito de sua aplicação ou cobertura por meio
do Premera Blue Cross. Poderão existir datas importantes neste aviso.
Talvez seja necessário que você tome providências dentro de
determinados prazos para manter sua cobertura de saúde ou ajuda de
custos. Você tem o direito de obter esta informação e ajuda em seu idioma
e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).
Fa’asamoa (Samoan):
Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau
ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala
atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua
atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei
fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le
aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai
i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua
atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i
ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471
(TTY: 800-842-5357).
Español (Spanish):
Este Aviso contiene información importante. Es posible que este aviso
contenga información importante acerca de su solicitud o cobertura a
través de Premera Blue Cross. Es posible que haya fechas clave en este
aviso. Es posible que deba tomar alguna medida antes de determinadas
fechas para mantener su cobertura médica o ayuda con los costos. Usted
tiene derecho a recibir esta información y ayuda en su idioma sin costo
alguno. Llame al 800-722-1471 (TTY: 800-842-5357).
Tagalog (Tagalog):
Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang
paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon
tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue
Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring
mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang
panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na
walang gastos. May karapatan ka na makakuha ng ganitong impormasyon
at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471
(TTY: 800-842-5357).
ไทย (Thai):
ประกาศนี ้มีข้อมูลสําคัญ ประกาศนี ้อาจมีข้อมูลที่สําคัญเกี่ยวกับการการสมัครหรื อขอบเขตประกัน
สุขภาพของคุณผ่าน Premera Blue Cross และอาจมีกําหนดการในประกาศนี ้ คุณอาจจะต้ อง
ดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกันสุขภาพของคุณหรื อการช่วยเหลือที่
มีค่าใช้ จ่าย คุณมีสิทธิที่จะได้ รับข้ อมูลและความช่วยเหลือนี ้ในภาษาของคุณโดยไม่มีค่าใช้ จ่าย โทร
800-722-1471 (TTY: 800-842-5357)
Український (Ukrainian):
Це повідомлення містить важливу інформацію. Це повідомлення
може містити важливу інформацію про Ваше звернення щодо
страхувального покриття через Premera Blue Cross. Зверніть увагу на
ключові дати, які можуть бути вказані у цьому повідомленні. Існує
імовірність того, що Вам треба буде здійснити певні кроки у конкретні
кінцеві строки для того, щоб зберегти Ваше медичне страхування або
отримати фінансову допомогу. У Вас є право на отримання цієї
інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за
номером телефону 800-722-1471 (TTY: 800-842-5357).
Tiếng Việt (Vietnamese):
Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông
tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua
chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông
báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn
để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có
quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình
miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).