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  #51  
Old 05-10-2006, 10:14 AM
David David is offline
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You are correct in the fact that the "approvable" letter was only for 1 level Prodisc, which is why I am unfortunately presuming that the upcoming Prodisc announcement will be actual approval for 1 level only

My presumption is that multi-level Prodisc approval will probably be <STRIKE>approximately</STRIKE> 6 months after the first approval.

Now, that all being said, I can be optimistic and hope that both single level and multi-level Prodisc will be approved at the same time. I just doubt it

David
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47 years old
Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.)
L4-S1: Prodisc
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  #52  
Old 05-10-2006, 10:14 AM
chasswen chasswen is offline
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well i just finished scanning all my med reports for sending to dr b. along with my dexa scan which was good l1 to l4 was t score was .03 and my left hip was 0.0.
dont know why L5 was'nt tested and i have my last ctscan and mri films on a cd for easier mailing.
so they have another 3 wks. for prodisc approval before i start the pro-spine contact procedure.
chuck
__________________
ddd 1990
2003 mri,xrays,shots,emg
2004 discogram ouch pos l4 l5
facet block neg
lost all appeals BCBS 5 months of that
3 surgeons later
surgery with dr. bertagnoli aug 2nd 2006 in Bogen Germany Successfully ProDisc-L L-4 L-5
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  #53  
Old 05-10-2006, 10:55 AM
Mariaa Mariaa is offline
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Dr.B has seen my scans twice now, tho not since 2005 and not recent CT scan/dexa scan results.

I'm not sure whether L5 was done on my dexa scan either, have to locate it tho I was shocked to see L1 was a -2.9...my overall score was -2.2 and my hips were left -2.8 and right -2.9 so my PCP told me to be more concerned about hip fracture than my spine ...of course, hips "feel" fine~

I just hope 2 level Prodisc is approved in case a discogram would yield it necessary for L3-L5S1 to be done and L5S1 would be a fusion for me.. (altho if this surgeon doesn't mention performing disco in his plan to UR..there's trouble right there as far as I'm concerned)~

Either way, the surgeon I saw has a timeline to send back necessary forms filled out so that technicalities wouldn't hang it up for WC UR, and I think that timeline was 20 days from when he received notice (Oct.24th).
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  #54  
Old 05-10-2006, 11:18 AM
chasswen chasswen is offline
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i hope it works out for you mariaa.dealing with doctors in the usa mosty is a pain in the butt. either there idiots or or have god like complex.
i'm really begining to see why my father wouldn't go to the doctors for all the bullcrap that goes with it.and he died at 62 a few yrs back.
chuck
__________________
ddd 1990
2003 mri,xrays,shots,emg
2004 discogram ouch pos l4 l5
facet block neg
lost all appeals BCBS 5 months of that
3 surgeons later
surgery with dr. bertagnoli aug 2nd 2006 in Bogen Germany Successfully ProDisc-L L-4 L-5
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  #55  
Old 05-10-2006, 12:04 PM
Mariaa Mariaa is offline
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Chuck,
Having worked in nursing for 25 years plus I'm more or less used to what I have seen although must admit dislike being on the patient end of things much more than working w/surgeons...

In the last 30 years, there has been a staggering decline of manners and courtesy from what I've noted in terms of replies/patient handling.

I'm sure there is much contributing to this phenomenon, however, while I think being a gifted surgeon may not include the ability to be a "people person" so to speak, I think that common decency and manners is part of what is necessary for me to feel comfortable with a treating physician/surgeon.
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  #56  
Old 05-10-2006, 03:37 PM
Ken (AKA-KP) Ken (AKA-KP) is offline
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I just want to throw this out there for food for thought. I have spoken with Dr. Yue's office about the FDA approval of pro disc and tehy expect it very soon. However, they were quick to inform me that even if the FDA approves the pro disc does not mean that the insurance companies will cover the surgery. They stated that the Charite was approved in 2004 and insurance companies are still not paying for the ADR surgeries (except one). Off to Germany 06-06-06.
__________________
Diagnosed with DDD, L4/L5 fused in 2002. Been told I need 2 maybe three level ADR
2-Level Pro-
Disc by Dr. Bertagnoli, Straubing, Germany 06-07-06
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  #57  
Old 05-10-2006, 03:44 PM
David David is offline
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Quote:
I just want to throw this out there for food for thought. I have spoken with Dr. Yue's office about the FDA approval of pro disc and tehy expect it very soon. However, they were quick to inform me that even if the FDA approves the pro disc does not mean that the insurance companies will cover the surgery. They stated that the Charite was approved in 2004 and insurance companies are still not paying for the ADR surgeries (except one). Off to Germany 06-06-06.
Understood, but did they say 1 level or 2 level approval? I am also working with Dr. Yue, and I think (*opinion*) that 1 level approval will probably be very shortly (guess: 2 months, max). Obviously, this doesn't help me out much, but it should enable Dr. Yue to start with the 1 level part of the Activ-L study shortly (90 days after approval).

I would also theorize (as Dr. Yue's office states) that most insurance companies will be hesistant (at best) to cover Prodisc, once approved.

Therefore, for me, personally, I think that my best options are either:

Wait for Activ-L study --or--
Go to Germany

If I were to wait in the U.S. for multi-level Prodisc approval, and then try to get my insurance company to cover for it (UHC), I think I would be in for a long fight (multi-year, probably).

Food for thought...

Edit: For some reason, I keep waiting, thinking that the waiting will be worth it (unlike you, who has already made the decision that I wish I already had made)

David
__________________
47 years old
Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.)
L4-S1: Prodisc
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  #58  
Old 05-10-2006, 04:27 PM
Ken (AKA-KP) Ken (AKA-KP) is offline
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If my memory serves me right they said the pro disc approval will be for two level. The rep from Dr. Yue's office said the insurance companies will probably not cover for a while much like the FDA approval of the charite in 2004 and still no insurance coverage.
__________________
Diagnosed with DDD, L4/L5 fused in 2002. Been told I need 2 maybe three level ADR
2-Level Pro-
Disc by Dr. Bertagnoli, Straubing, Germany 06-07-06
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  #59  
Old 05-10-2006, 09:32 PM
LBP LBP is offline
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Here's a question for all you insurance challenged people like myself....we all know that as soon as ProDisc gets FDA approval...we are at least entitled to file new claims for coverage even if we've already been denied for Charite and may get denied again for ProDisc...but my question is: what if you've already been denied for Charite but now there's a new version of Charite approved with the special coating see

http://www.accessdata.fda.gov/script...MA.cfm?ID=5245

Is the new and improved version of the Charite a whole new product entitled to a whole new appeal process again????

And on a related note...for me I am a 2 level...if you've been denied a 2 level ADR (Charite) can I get a whole new appeal process started with a claim for a hybrid Charite and fusion???
__________________
Injured 9/01
Annular tears L4/5 & L5/S1
denied adr by insurance for 2 level charite as well as hybrid fusion at L5/S1 with Charite at L4/5.

New ins paid for 2 level lumbar prodisc surgery on 4/7/08 (at age 39) with Dr. Westerlund, at Core Orthop
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  #60  
Old 05-11-2006, 04:47 AM
David David is offline
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Quote:
If my memory serves me right they said the pro disc approval will be for two level. The rep from Dr. Yue's office said the insurance companies will probably not cover for a while much like the FDA approval of the charite in 2004 and still no insurance coverage.
I am presuming by "they", that you mean Dr. Yue's office?

If true, that would be some good news in my otherwise dismal life

David
__________________
47 years old
Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.)
L4-S1: Prodisc
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