[Date]
[Insurance Company Name]
[Insurance Fax #]
RE: Request for Predetermination of Coverage for Two-Level Cervical Total Disc
Replacement
[Patient Name]
[Patient DOB]
[Patient Policy Number]
[Patient Group Number]
To Whom It May Concern:
This letter is to request a predetermination of coverage for a Cervical Total Disc
Replacement (CTDR) procedure at two levels with the Mobi-C Cervical Disc for my patient,
[Patient First and Last Name (Patient DOB, Patient Policy and Group Number)]. Medical
necessity is well-documented in the Certificate of Medical Necessity and the patient records
enclosed.
According to FDA-approved labeling: “Mobi-C is indicated in skeletally mature patients for
reconstruction of the disc from C3-C7 following discectomy at 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. Mobi-C is implanted using an
anterior approach. Patients should have failed at least 6 weeks of conservative treatment or
demonstrated progressive signs or symptoms despite non-operative treatment prior to
implantation of Mobi-C.”1
I believe that my patient meets all of these criteria for a two-level arthroplasty. I am
choosing this procedure over a fusion in this case because of the patient’s age and anatomy,
as well as because of the strength of the long-term data associated with the procedure, in
particular the following data from a recent publication by neurosurgeon Dr. Reginald Davis
and his colleagues2:
FDA Approval Information: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=10689.
Davis RJ, Nunley PD, Kim KD, Hisey MS, Jackson RJ, Bae HW, Hoffman GA, Gaede SE, Danielson GO, 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. 22(1): 15-25, 2015.
1
2
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Overall trial success was 69.7% for Mobi-C and 37.4% for fusion (statistically superior)
The rate of secondary surgeries at the operated level for Mobi-C was 3.1% versus 11.4%
for fusion over a four-year time period
The percentage of subjects who demonstrated adjacent segment degeneration
(determined by x-ray) over a four-year time period was:
- 2.9% of Mobi-C patients compared to 18.1% of ACDF patients at the inferior
adjacent level
- 13.1% of Mobi-C patients compared to 33.3% of ACDF patients at the superior
adjacent level
78.2% of Mobi-C patients showed improvement in Neck Disability Index (NDI) based on
the FDA success criteria versus 61.8% of fusion patients
All of the data associated with the Mobi-C technology in particular can be found via the
bibliography attached.
Based on this information, I respectfully request a positive predetermination of coverage for
a two-level CTDR with Mobi-C Cervical Disc replacement for my patient. If you require
additional information, please feel free to contact me directly.
Sincerely,
[Physician Name]
[Practice Name]
[Physician Address]
[Physician Phone #]
Enclosures
Certificate of Medical Necessity
Patient Records
Mobi-C FDA Approval Letter
Mobi-C Bibliography
MB RF 13 REV A 04.2015