[Name of Department (for example ‘Medical Review’ or ‘Appeals’)]
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:
[Exercise to neck/shoulder area]
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:
Fewer secondary surgeries at the index levels compared to fusion.
Lower rates of adverse events determined to be major complications compared to fusion.
Lower rates of adjacent level degeneration compared to fusion.
A higher Neck Disability Index success rate compared to fusion.
A mean range of motion in flexion/extension of 10.1° at the superior index level and 8.3° at the inferior index level.
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,
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.
[Physician Name], [Degree]
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-Cvs. Fusion The available IDE data demonstrates that Mobi-Cperforms 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 postoperative study visits. On average, the Mobi-C study group maintained preoperative mobility at the treated segments.
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.
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.
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-Cand 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.
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 MobiC 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