Provider First Appeal Example: Two-Level Mobi-C®
[SURGEON LETTERHEAD]
[Date]
[Health Plan Name]
[Name of Department (for example ‘Medical Review’ or ‘Appeals’)]
[Address]
RE:
[Patient Name]
[Insurance Identification #]
[Reference or EOB #]
[Primary CPT Code]
[Primary DX Code]
To Whom it May Concern:
On behalf of the above-referenced patient, I am writing in regard to your recent denial of medically
necessary services. The denial reason reflected in your letter of [Insert date] states [Reason for
denial]. I firmly disagree with your determination. This letter and its supporting documents will
provide you with a better understanding of this patient’s clinical history and need for a two-level
Mobi-C® Cervical Total Disc Replacement (CTDR).
Patient’s Clinical Need for Two-Level CTDR
Insert patient history, for example:
[Patient’s name] presented to me on [Date] with a history of [Describe symptoms with specificity,
including arm pain and/or neurological deficit with or without neck pain]. [He/she] has
radiographic evidence of [Insert diagnosis]. The degree of [Insert diagnosis] is
[Moderate/moderate to severe/severe] at [Insert levels]. [He/she] experiences debilitating pain
that has limited daily functions that include: [Insert daily functions and activities]. The symptoms
discussed above are exacerbated by: [Insert daily activities]. Conservative treatment has consisted
of [Insert description] for [Insert length of time]. The prior treatments included:
1.
2.
3.
4.
5.
6.
[Exercise to neck/shoulder area]
[Neck appliances]
[Traction]
[Anti-inflammatories]
[Muscle relaxants/narcotics]
[Ice/heat]
I have determined that this patient is a candidate for two-level CTDR, utilizing the Mobi-C device
because [Insert rationale].
Request for Coverage
Coverage is appropriate based on the:
 Patient’s medical need, as I have described above.
 Mobi-C FDA cleared indications.
 IDE established safety and effectiveness of the Mobi-C1. At 24 months, Mobi-C demonstrated:
o Fewer secondary surgeries at the index levels compared to fusion.
o Lower rates of adverse events determined to be major complications compared to fusion.
o Lower rates of adjacent level degeneration compared to fusion.
o A higher Neck Disability Index success rate compared to fusion.
o A mean range of motion in flexion/extension of 10.1° at the superior index level and 8.3° at
the inferior index level.
o A mean return to work time 20.9 days shorter than fusion.
I refer you to the FDA Approval Order Statement [Attached] and to the following peer-reviewed
journal article, describing the Mobi-C clinical trial results (additional peer-reviewed journal articles
footnoted2,3,4,5:
Davis, Reginald J., et.al.; Cervical Total Disc Replacement With The Mobi-C Cervical Artificial Disc
Compared With Anterior Discectomy And Fusion For Treatment Of 2-Level Symptomatic Degenerative
Disc Disease: A Prospective, Randomized, Controlled Multicenter Clinical Trial,
J Neurosurg Spine 19:532–545, 2013 532 ©AANS, 2013
Mobi-C’s established safety and effectiveness, as well as the IDE established benefits, demonstrate
clear reason for supporting the use of Mobi-C.
To assist in your reconsideration of this patient’s clinical need for the intended procedure, a copy of
the relevant clinical notes [Attached] that support use of Mobi-C is enclosed in order to support you
in your decision to overturn the initial denial of coverage for these services.
Thank you for your consideration of this information. Should you have further questions or
concerns, please do not hesitate to call me at [Insert physician telephone number]. I look forward to
your favorable reply.
Sincerely,
[Physician Name], [Degree]
[Practice Name]
1
Please refer to the Mobi-C Summary of Safety and Effectiveness Data (PMA P110009) at www.fda.gov for complete study
results.
2 Beaurain J, Bernard P, Dufour T, Fuentes JM, Hovorka I, Huppert J, Steib JB, Vital JM, Aubourg L, Vila T: Intermediate Clinical
And Radiological Results Of Cervical TDR (Mobi-C) With Up To 2 Years Of Follow-Up. Eur Spine J 18(6):841-850, 2009
3 Hisey, Michael S., et.al.; Multi-center, Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial
Comparing Mobi-C Cervical Artificial Disc to Anterior Discectomy and Fusion in the Treatment of Symptomatic Degenerative Disc
Disease in the Cervical Spine; International Journal of Spine Surgery, Vol. 8
4 Huppert J, Beaurain J, Steib J, Bernard P, Dufour T, Hovorka I, Stecken J, Dam-Hieu P, Fuentes JM, Vital JM, Vila T, Aubourg L:
Comparison Between Single- And Multi-Level Patients: Clinical And Radiological Outcomes 2 Years After Cervical Disc
Replacement. Eur Spine J 20: 1417-1426, 2011
5 Vital JM T, Boissiere L, Obeid I: C6-C7 Cervical Disc Arthroplasty In Cervical Disc Herniation. Eur Spine J 22:2136-2138, 2013
About Mobi-C
The Mobi-C Cervical Disc was designed to minimize stress between implant and bone with a mobile
core, thus eliminating the need for more aggressive fixation mechanisms such as keels and screws.
The Mobi-C Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc
from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy
(arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to
abnormality localized to the level of the disc space and at least one of the following conditions
confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis
(defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent
levels. The Mobi-C Cervical Disc is implanted using an anterior approach. Patients should have
failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms
despite nonoperative treatment prior to implantation of the Mobi-C Cervical Disc.
Mobi-C has been used in more than 17,000 implantations worldwide since 2004 in more than 25
countries.6 LDR received FDA approval for Mobi-C in August 2013. Although several alternate
cervical disc prostheses have previously entered the U.S. market via the PMA pathway, Mobi-C is
the only device with Level I evidence supporting its use at two cervical levels, and is the first and
only cervical disc approved by the FDA for two-level use.
Mobi-C vs. Fusion
The available IDE data demonstrates that Mobi-C performs as well as or better than fusion. 7
 The overall study success rates at 24 months were 69.7% for Mobi-C and 37.4% for fusion,
which established statistical superiority of the Mobi-C.
 Fusion patients, as expected, showed restricted range of motion at all post-operative study
visits. On average, the Mobi-C study group maintained preoperative mobility at the treated
segments.
o Mobi-C is designed to self-adjust and move with the spine in a natural range of motion.
 The 2-year radiographic analysis indicated significantly less adjacent segment degeneration in
the Mobi-C group.
o An instrumented fusion procedure involves the use of screws, plates, and/or cages to keep
the bones from moving. It has been postulated that the restriction of motion at the treated
segment with a fusion is one factor contributing to the development of adjacent level
disease.3
 Patients in the fusion group were more than three times more likely to require a subsequent
surgical intervention and twice as likely to have an adverse event related to the device when
compared with the Mobi-C. The Mobi-C study group also had a significantly lower rate of
serious adverse events.
See also: http://www.cxvascular.com/sn-latest-news/spinal-news---latest-news/clinical-studies-on-ldrs-mobi-ccervical-disc-presented-at-nass#sthash.IUXKqnd0.dpuf
7 Davis, Reginald J., et.al.; Cervical Total Disc Replacement With The Mobi-C Cervical Artificial Disc Compared With Anterior
Discectomy And Fusion For Treatment Of 2-Level Symptomatic Degenerative Disc Disease: A Prospective, Randomized,
Controlled Multicenter Clinical Trial, J Neurosurg Spine 19:532–545, 2013 532 ©AANS, 2013
6
The preclinical and clinical data support the reasonable assurance of safety and effectiveness of
Mobi-C when used in accordance with the indications for use. Based on the clinical study results, it
is reasonable to conclude that the clinical benefits of Mobi-C in terms of improvement in pain and
disability and the potential for motion preservation, outweigh the risks. (This includes both the
risks associated with Mobi-C and the surgical procedure risks, when used in the indicated
population in accordance with the directions for use and as compared to the fusion control
treatment in the same indicated population.)
These data provide compelling Level I evidence in support of two-level Mobi-C as an alternative to
two-level fusion in properly indicated patients.
CN 1143 MB RS 5 Rev. A 08.2014