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Old 06-18-2011, 03:20 PM
winecaptain winecaptain is offline
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Join Date: Nov 2010
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Having recently just completed a Prodisc-C at C6-C7, I only wish that I had done it sooner. I too live in Florida (Tampa Bay Area). I highly recommend my physician, Dr. Jim Billys in Tampa, as he has done several ADRs and from my personal experience was a true expert as it related to my case. Your other issue, however, may be the bigger problem (only my opinion here from lots of reading and investigation, so do not take my information as gospel). The current FDA indication for Cervical Arthroplasty is for single level disc only (see www.fda.gov). This is where the insurance companies come in with their reviews and decisions. I work in the medical device industry (although not spine), but understand insurance coverage and it's relationship to payments for both on and off label procedures.

Technically, a multi-level ADR is "off label" and therefore getting it covered by most carriers in the US is going to be extremely difficult. Before I would give up on this though, I would exhaust all options here by writing letters of medical necessity, as all carriers have appeals processes. They will most likely tell you that it is "experimental" and "unproven", which only means that there has yet to be a large clinical trial done in the US to gain the indication. Clearly, we all know that these procedures have been done OUS for quite some time, however there is very little clinical data substantiating the long term efficacy. This is where our medical system can be both challenging and frustrating.

On one hand, we have one of the "safest" medical systems in the world (devices that are approved in the US undergo the most rigorous clinical testing and require that they are at least as safe and effective as other products that are all ready in use), however on the other hand when it comes to getting new or expanded approvals for products, we fall behind Europe, Asia, and other parts of the world, because of this same rigorous approval process.

Another issue here is that since the current level of approval is for single level disease, it is much easier and cheaper to get new products approved the same indication. If you think about all of this from a purely economic standpoint, it becomes virtually cost prohibitive for a company with an ADR product, to undergo a large clinical study to prove both safety and efficacy for multi level cervical disk replacements in the US. A study to expand this indication in the US would most likely cost $25-50MM +. Then they would then have to wait for the outcomes to show that they were statistically at least as safe and efficacious as a fusion. Unfortunately for those of us who are patients, this is why products are approved outside the US so many years ahead of the US.

With all of that said, I have read about good results with hybrid procedures (fusion at one level and ADR at an adjacent level), which may be easier to get covered in the US by a private carrier. The other real option is to look overseas, or "cash pay" for your off-label procedure here. I know both of these sound less than desirable, however in our current medical world, I am not sure that there are really too many other options for multi-level cervical disc patients in the US today.

I wish your husband the best with his decision process and recovery. I can only say that I am 100% glad that I had my procedure done and only wish that I had done it sooner. All the best!
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41 y/o Male, Successful Disc Arthroplasty Procedure (Prodisc C in Tampa, FL) with excellent outcome June 2011... January 2012 had 3rd episode of "throwing out my back", Lumbar Pain radiating down buttocks and into both legs, MRI shows centrally Herniated L5-S1, Bilateral S1 ESI scheduled beginning March 2012...

Last edited by Harrison; 06-18-2011 at 03:36 PM. Reason: minor formatting for ease of reading
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