Insurance Company Name Insurance Address City, State Zip
[Date]
[Insurance Company Name]
[Insurance Address]
[City, State Zip]
RE: [Patient Name]
[Patient DOB]
[Patient Policy Number]
[Patient Group Number]
Prior-Authorization Request: One-Level Cervical Artificial Disc Replacement
To Whom It May Concern:
This letter is to request prior authorization of coverage for a Cervical Total Disc Replacement (CTDR) procedure with the Mobi-C® Cervical Disc for the above-referenced patient. Medical necessity is well documented in the medical records provided.
[Patient’s name] has been diagnosed with [Insert description of diagnosis]. Per [his/her] medical history this patient has exhibited: [Insert description of symptoms and past treatments inclusive of conservative care].
It is important to note that although this patient’s radiologic findings may indicate multi-level degenerative disc disease, symptoms are resulting from a single level abnormality localized to a one level disc space at [Insert disc level], thus meeting FDA’s indications for use.
My patient is a candidate for CTDR as opposed to fusion because [Insert reasons].
Based on this information, I respectfully request prior authorization of a Mobi-C Cervical Disc replacement for [Insert patient’s name]. If you require additional information, please feel free to contact me directly.
Sincerely,
[Physician Name]
[Physician Address]
[Physician Telephone Number]
About Mobi-C
The Mobi-C is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one 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 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. [1]
Key results of the Mobi-C one-level clinical study are:
• Overall trial success was 73.7% for Mobi-C and 65.3% for fusion
• The rate of secondary surgeries at the operated level for Mobi-C was 1.2% versus 6.2% for fusion.
• The percentage of subjects who demonstrated adjacent segment degeneration (determined by x-ray) was:
- 7.7% of Mobi-C patients compared to 21.0% of ACDF patients at the inferior adjacent level.
- 14.6% of Mobi-C patients compared to 33.3% of ACDF patients at the superior adjacent level.
• Mobi-C patients had mean return to work time of 7.5 days shorter than fusion patients.
• 79.4% of Mobi-C patients showed improvement in Neck Disability Index (NDI) based on the FDA success criteria versus 77.1% of fusion patients.
MB RS 2 REV A 08.2014
[1] FDA Approval Information: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=11027