I'm in desperate need of a Charite disc replacment & I've been waiting since May of 2004. I go to the Southeastern Spine Institute in Charleston, SC & they are very proactive in this proceedure. My surgeon, Donald Johnson decided I was a prime canditate for this proceedure last May & gave me the option of fussion or waiting untill around the end of the year when it becomes FDA approved which is what I chose to do. I have been taking about 200mg of morphine daily for a year now & really want this surgery. I emailed the FDA & stayed in touch with them all of last year getting updates as to when it would be on the market. Now after all of this time my insurance CO is refusing to cover it. They say it is investigational & not an approved alternative proceedure. I've talked till I'm blue & I'm getting nowhere. If anyone has any littature that I could use to prove that this is an approved alternative proceedure to spinal fussion please help. My email address is thoroughbredsinc@aol.com . My insurance Co is Thomas Cooper. Any help would be greatly appreciated.

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TIRED OF WAITING....

MM, please look through the posts in this forum. You'll find lots of info. ADR was approved in October of 2004. See here for more:

http://www.adrsupport.org/content.asp?cid=199

Also, remember that you (Morphineman) are not limited to a Charite implant.....there are at least three others that are in the FDA study phase (Prodisc, Maverick and Flexicore)....and at least one of these (prodisc) is at the continued access stage of the study where multiple discs are allowed. The trick with the studies is to get accepted and worked on before the surgeon you choose is out of allotments (ie, they get to do X number of procedures and no more without written authorization from the FDA).

I am just telling you this so you understand the range of your options better....I am not suggesting that one type of disc is better than the other (although I do have my own opinions on this).....Good luck to you friend.

ESL thanks for the info. I didn't know about the availability of the other disc. there was a study done here in South Carolina for about twenty months ending last May. It was for the Maverick & I know people that have it & are very pleased so far. I'm ready to try anything that I could get insurance approval for. The Southeastern Spine Institute here in Charleston is supposed to be one of the leaders in this industry from everythinh I've heard. My Surgen Dr Don Johnson is one of the Dr's responsible for training new surgeons on this proceedure & still I can't get anywhere with my insurance Co. I'm in the second level of the appeal process now & I don't see it getting any better unless I can come up with some very convincing doccumentation. I just keep hearing trhe same thing, "it investigational". I'm not giving up though not for a minute!!

MM

the closed study ....is it truly closed or is the initial phased closed....sometimes they have these continued access phases where there is no more randomaization (meaning you have a 1 in 3 chance of getting a fusion instead of the adr)........you might want to ask them if they have such a thing going now....I actually chose not to participate during the randomization phase and waited for the continued access phase.

Thomas,
Good advice given above.. best of luck w/this!
One thing, I would remove your phone # off cyber space~ email should be enough should someone want to contact you privately and get this info...

MSO4 Man,

One of the first things I would try and do is find out who your RN Case Manager is from that insurance company. (assuming that they have RN Case Managers). IF you do not have one (yet) asked to be assigned to one. Part of their job is to do the research on your case and on ADR and help facilitate the process for approval.

IF they are unwilling to OR do not have a Case Manager to correspond with, then the only other thing i can think of is going through the appeals process.

I don't know if there on any legal people on here that deals with insurance companies - but sometimes I wonder that if a medical device is FDA approved and a physician/surgeon states that this procedure is medically necessary for a patient - On what grounds can they refuse coverage for this? - Especially knowing that ADR is FDA approved? Perhaps, I should post this question on another thread.... Hummmm....

Clarification: I am referring to patients that are candidates for the Charite ADR - One level replacements (Lumbar). http://adrsupport.org/groupee_common...icon_smile.gif

Poncho, If you do post on another thred & get any usefull information please forward it on. I am a certified paitent for the Charite ADR. Lumbar L5 S1. I did try to get in under a randomized study last year for the maverick & was scheduled for surgery & the day I went in for pre-op preperations the study ended. So I made the decession along with my Surgeon to wait for the approval of the Charite ADR which was antipated around the end of 2004. Now I'm in the second level of appeal process with Beach Street CO. They are the co that approves or dissaproves surgical proceedures for the Insurance Co Thomas Cooper. I've forwarded letters from FDA stateing that it is "NOT INVESTIGATIONAL" & marketed for use. I'm told by them that they don't really care what FDA has to say because the independand orthopedic surgeon they consult says there are no long term study on the effects of this proceedure. It has been used in Europe for years with amazing results & even the two year study that was done here had outstanding results. Still they insist on spinal fuission. I argue that there are long term study on the negative effects of fussion & that is why I don't want that, especially now that we have new techknowledgy. If anyone knows anything else that I can through at them It certainly can't hurt. Tired of taking 200+ mg Morphine daily...