Bi-Level ADR FDA Approval in U.S.?

[JJames]

Although I too have many questions regarding the pros, cons, successes, and horror stories regarding ADR surgery, I am convinced after so many years in pain, so many different tests and treatments, medications, procedures, and the opinions of 5+ surgeons that my best option to treat the DDD which has left me with annular tears in my L4/L5 and L5/S1 discs is the bi-level ADR surgery on these. Especially, due to the pain and indications that I have other discs which already have more minor issues.

My question is, that after waiting for over a year (based upon when I believe the procedure was submitted to the U.S. FDA) for the procedure to be approved in the U.S. there does not appear to be any way to get the status of where this stands! I have not even been able to confirm it was ever submitted to the FDA! I've gone to the www.fda.gov website, and that is so confusing it is useless to me. I don't know where to look or who to ask.

Does anyone have any resources or answers for me to look into? I have researched the possibilities of going out-of-country and or paying out-of-pocket in the U.S. and neither make sense to me. Any complications from the procedure (which I would have to beg, borrow, and steal to pay for) would not be covered by my medical insurance! I am already living week-to-week and cannot leave my wife and children in such a financial bind.

Any information or suggestions would be greatly appreciated. Thank you so much, and good luck to all.

[Cathyjp]

hang in there! Your family and friends are all by your side.

[JJames]

hang in there! Your family and friends are all by your side.

Thank you, honey but I really wasn't searching for a response from my wife (although I do appreciate it)! Guess it isn't a good idea to be on the same site(s) as you are.

[Liz]

hi jjames,

sorry for the battle w/FDA approvals.

i would recommend contacting Synthes, the manufacturers of Prodisc, if you have not already re: anticipated FDA approval of two-level lumbar Prodisc, http://www.synthes.com/html/. I've spoken w/them pre- and post-op and they are very helpful.

Dr. Yue should be able to give you the inside scoop as well. Is Dr. Yue still participating in the Activ-L trial? If so, sometimes doctors in the trials can petition the FDA for a compassionate exemption (or something like that) for two-level cases.

Would your insurance pay for one-level Prodisc as part of a hybrid operation (w/a fusion)?

if i remember correctly, there is a guy on this forum that recently had a 4-level lumbar Prodisc w/Dr. Yue... i can't remember his name, but i'm sure Dr. Yue would... wonder how he made that happen?!

Best of luck,
Liz

[kimmers]

Jjames,

I would see if your insurance can really deny you treatment after an "unapproved" or "not certified" surgery. I think they are going beyond what it says in their policy book. If your policy book does not say that then they shouldn't be able to do that.
Even my crappy insurance pays for my post-ADR treatment.

I have seen this before and I think this is illegal.
Health insurance sucks but they do have some obligations especially when you or your company is paying for a service.

I ditto all of the above, too. Fight. I did and got my surgery approved and then I fought some more when BC did not pay for it.
Do not give up and throw up your hands and throw in the towel.
I don't know your exact circumstances but there are resources out there to help you.

Kimmers

[Sandra L]

Jjames,

I went to Germany for my 4 level and my insurance pays for all doctor and procedures needed in my follow up, both Medicare and my secondary, Anthem Blue Cross/Shield. Medicare will not cover any ADR in or out of country. Am trying to get my secondary to cover, after the fact, which they previously said they would do (even got a check for $99) for a bill at St. Elisabeth, Straubing, Germany). Then they started giving me the run around which I expected, but will keep trying.

I went to Germany for surgery: 1) no one would do a 4-level here and one of the gurus of multiple levels is Dr. Bertagnoli, so why not go to the one with the most experience. 2) even if there was someone here that would do it, out of pocket, even with flights and hotels, was cheaper in Germany.

You are so close to Dr. Yue at Yale, I would make an appointment with him. He is probably the most experienced on the east coast, and has been involved in the clinical study and approval of the ProDisc-C made by Synthes in PA. He and Dr. B have written articles together and he has trained with Dr. B here and in Germany. If anyone can help you with a decision and with insurance, I'm sure he could.

Kimmers wonder how he made that happen?!

I think?? this happens in the early stages, before it goes into clinical studies and the FDA becomes involved. Somehow they get insurance companies to pay for "a fusion", the manufacture donates the device, instruments, maybe pays the doctor, hospital, something? I read that paulam310 (http://www.adrsupport.org/forums/member.php?u=3069) received a 3-level ProDisc-C in 2004 with Dr. Delamarter and his insurance paid. That was before PD-C was in clinical trials?, it only got FDA approval for 1-level in December 2007. So who knows what happens. What good is FDA approval if your insurance won't pay.

Maybe with Obama, some of this will get changed. Republicans don't yell at me, I'm one of you and don't believe in socialized medicine (talk to the Canadians). The insurance companies profits are huge and the exec's are paid well, so I'd think it would be moral of them to "share", opps there I go again. SORRY, didn't mean to :rant: and rave.

Good luck Jjames! I think the post from your wife and your response were great.

Sandy

[Sandra L]

JJames, guess I should read everything. I see you are going to Dr. Yue. Boy if he can't help you, the only thing that may work is calling Synthes and asking for their help?? Sandy

[JJames]

I at least wanted to thank all of you so much for your insight and thoughts. I am not feeling very well at all today - alright, honestly I feel horrible. I have an appt with Dr Yue on April 1st. I will reply in greater length when I feel better, but I wanted everyone to know how much I appreciated the responses. Thank you.

[Slackwater]

(del.text) after so many years in pain, so many different tests and treatments, medications, procedures, and the opinions of 5+ surgeons

My question is, that after waiting for over a year (based upon when I believe the procedure was submitted to the U.S. FDA) for the procedure to be approved in the U.S. there does not appear to be any way to get the status of where this stands! I have not even been able to confirm it was ever submitted to the FDA! I've gone to the www.fda.gov (http://www.fda.gov) website, and that is so confusing it is useless to me. I don't know where to look or who to ask.


Five (5) surgeons, understand.
Four (4) surgeons on this side;
differing recommendations.


The two-level lumbar results may not be totally compiled or published. I suggest from my recall of professional journal abstracts (Spine, ISSLS, The Spine Journal, European Spine Journal) is there may be FDA controlled testing of two-level lumbar ADR, TDR, TDA, IVD ...

Clinical Trials website (http://www.clinicaltrials.gov), as an example see Prodisc two-level (http://www.clinicaltrials.gov/ct2/show/NCT00295009?term=two+level+replacement+disc&rank=1) is public information; this link may expire as it is a search link. Clinical Trials Identifier is NCT00295009 (http://clinicaltrials.gov/ct2/show/NCT00295009) , but his leads you back to the Prodisc single-level.


FDA
I am a layperson, not a governmental law expert, not a medical professionial, ... FDA Center for Device and Radiological Health (CDRH www.fda.gov/cdrh (http://www.fda.gov/cdrh) ) is responsible for Artificial Disc Replacements . ADR is subject to Pre-Market Approval (PMA).


FDA CDRH PMA Frequently Asked Question (FAQs, link (http://www.fda.gov/cdrh/devadvice/pma/frequently_asked.html)) :

How can I find more information about a PMA under review?
Before FDA approves or disapproves a PMA, FDA will not disclose the existence of the PMA unless it previously has been publicly disclosed or acknowledged. Even if the existence of the PMA has been publicly disclosed or acknowledged, data or information contained in the file are not available for public disclosure. However, FDA may disclose a summary of portions of the safety and effectiveness data, if disclosure is relevant to public consideration of a specific pending issue.
There is other language I read on CDRH on information disclosure that provides a blanket or shield on disclosure. I read the policy, but can not find it now.


The FDA is not required to disclose preliminary ( two-level ADR ) results. FDA CDRH is not a patient's best source of clinical data before approval.

One example of this might be the Aesculap Activ-L lumbar Artificial Disc Replacement. There was a press release from the German company's American subsidiary that the FDA Clinical Trial started, or about to start, and nothing showed up in searches of FDA, FDA/CDRH or ClinicialTrials.Gov.

[JJames]

hi jjames,

sorry for the battle w/FDA approvals.

i would recommend contacting Synthes, the manufacturers of Prodisc, if you have not already re: anticipated FDA approval of two-level lumbar Prodisc, http://www.synthes.com/html/. I've spoken w/them pre- and post-op and they are very helpful.

Dr. Yue should be able to give you the inside scoop as well. Is Dr. Yue still participating in the Activ-L trial? If so, sometimes doctors in the trials can petition the FDA for a compassionate exemption (or something like that) for two-level cases.

Would your insurance pay for one-level Prodisc as part of a hybrid operation (w/a fusion)?

if i remember correctly, there is a guy on this forum that recently had a 4-level lumbar Prodisc w/Dr. Yue... i can't remember his name, but i'm sure Dr. Yue would... wonder how he made that happen?!

Best of luck,
Liz

Thank you for your response, Liz. My wife has been in almost constant contact with someone at Synthes ever since Dr. Yue informed us of my best surgical option (in his opinion) and we were denied by my medical insurance. Dr. Yue seems to me to have moved away from the Activ-L and is strongly urging me to go with ProDisc.

I do not know if my med ins would pay for the hybrid operation, but I also don't think it is in my best interest - the fusion part concerns me greatly.

Perhaps all the battles with the ins companies have taken their toll on Dr. Yue, but he really gives me the impression that I must either wait for my medical insurance to pay or I need to show up at his office with a briefcase full of cash!

[JJames]

Jjames,

I would see if your insurance can really deny you treatment after an "unapproved" or "not certified" surgery. I think they are going beyond what it says in their policy book. If your policy book does not say that then they shouldn't be able to do that. Even my crappy insurance pays for my post-ADR treatment. I have seen this before and I think this is illegal.
Health insurance sucks but they do have some obligations especially when you or your company is paying for a service.

I ditto all of the above, too. Fight. I did and got my surgery approved and then I fought some more when BC did not pay for it.
Do not give up and throw up your hands and throw in the towel.
I don't know your exact circumstances but there are resources out there to help you.

Kimmers

That is very interesting about what my insurance company told me. I will need to check the policy book to see if it specifies anything regarding denying coverage if I paid out-of-pocket for the surgery. I honestly can't afford it anyway!

[JJames]

Thank you for the information, Slackwater. I followed some of the links you included. As you stated, there isn't a whole lot of information there, but what was present at least gave me some hope that the bi-level procdure "appears" to be being reviewed by the FDA. My wife has actually made a contact at the FDA, and he is unable to really say anything. It had never occurred to me - as my interest is purely to get my back fixed - that others could use such information to make money through investments if they were tipped off that the FDA was about to approve something! Boy do I have tunnel-vision or what???

[Slackwater]

1) Dr. Yue seems to me to have moved away from the Activ-L and is strongly urging me to go with ProDisc.

2) I do not know if my med ins would pay for the hybrid operation, but I also don't think it is in my best interest - the fusion part concerns me greatly.

3) I must either wait for my medical insurance to pay or I need to show up at his office with a briefcase full of cash!

1) Prodisc is FDA approved single level. Assume two-level Prodisc will be the first for two-level FDA approval, without any hard facts, just the way the publicly available trial data is laid out. Dr. Yue may also have filled his slots for the Activ-L™trial. Anything above a single-level in the FDA trial is an exception, probably requiring more paperwork than ...


2) Hybrid is ~OK from a limited layperson's view. I read at least one (1) ISSLS abstract and this one from 2008 EuroSpine:
Hybrid construct: fusion L5/S1 and disc arthroplasty L4/L5 for DDD, 3 years follow up
JC Le Huec MD PhD, S Aunoble MD, R Meyrat MD, C Tournier MD
Link (518 KB, .5 MB (http://eposter.eurospine.org/cm_data/eposter/SP3.pdf) PDF)


3) Similar, volunteered to pay for the two-level ADR on this side to connect the dots, or $ signs, to do my process thing. The insurance coverage position was online in my case:
yes: two-level fusion
yes: one-level ADR

no: two-level ADR
no: hybrid fusion+ADR, partial coverage of fusion or ADR
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

slackwater_sf

[ml]

I recently (17 days ago!) had a three level cervical ADR (ProDisc C) in Seattle, WA with Dr. Jens Chapman. Insurance issues are still pending....but at a minimum, my insurance company agreed to pay for everything except 2 of the actual implants. I am appealing their decision to not cover 2 of the implants. My understanding from my surgeon is that once the FDA approved an artificial disc for single level use, a dr. could use the device for multi levels without needing any approval from the FDA. "Off label" use of prescriptions and medical devices/implants is actually quite common. If you are negotiating or appealing a negative decision from your insurance company, you might want to google "off label" use on the FDA, Mayo Clinic, and other medical websites and use quotes from those published sources. It took two written appeals from my surgeon's office and myself and also several phone calls to and from my state's medical insurance commissioner, the H,R. department where I work as well as the broker for my medical insurance. Don't give up! You have the right to the best possible medical care and depending on your medical insurance, you might be able to force them to cover the costs. Speaking from personal experience, it seems like insurance companies usually say no at least once or twice, probably hoping that the consumer will give up. I refused to give up and was lucky enough to have a great dr. that was willing to help me with two appeals. I totally related to your comments about not feeling good......it is hard to deal with the basic day to day requirements when you are in constant pain. I was in a similar situation just a short time ago. I am happy to say that I already feel 100 times better than I did before my ADR surgery. The minor surgery pain I am recovering from is nothing compared to the daily pain I had from the DDD in my neck before surgery. It was worth the wait and the battle! Good luck! Melody

[JJames]

Melody, I am very happy to first hear that you are doing so well and second hear that someone was able to find a crack in the armor of the medical insurance wall of armor! My surgeon informed me that he "could" perform the surgery without any FDA-related issues, as it is what I need as his patient. My battle is with getting my medical insurance to pay for it. Unless it is an FDA approved procedure, the deem it "experimental" and use that as their loophole for not covering the procedure. I also consulted with, and received a defensive posture from both my company's HR Department and our medical insurance broker. My guess as to why this was the case is that the company which I work for is "self-insured". I don't know exactly what that means, but I am certain that these two individuals benefit from preventing the spending of any money! Unfortunately, I think my surgeon has been burned by the insurance companies enough in the past that if I cannot have anything ensuring they will be covering the procedure, I must pay up front and in full out-of-pocket! Glad to hear you're doing well and I will continue my fight.

[ml]

JJames,

It sounds like you are doing everything you can to get insurance to pay for the procedure. All I can suggest is that you keep doing what you are doing.....sometimes the squeaky wheel is the one that gets greased. The company I work for is also "self insured". Insurance companies (self insured or not) don't want want to lose money. I was costing my medical insurance company quite a bit of money to treat my chronic pain. I saw my GP monthly to get prescriptions for expensive meds, had twice monthly massages, went through an expensive series of diagnostic injections, tried chiropractic, acupucture, etc.....I sent the insurance company and HR a few letters that outlined those costs and reminded them that those monthly expenses would continue until I could have the surgery that my orthopedic surgeon believed was the best solution for me. I assured them that the costs would only keep mounting until they paid for ADR. The sooner I had the surgery, the less money the insurance company would have to pay in the long run. I also copied and mailed them any published material I could that was favorable to my case. I don't know what state you are in, but in Washington "self insured" companies fall under federal laws....I kept hearing the acronym "ERUSA". Have you consulted an attorney? Insurance companies don't want to have to pay attorney fees to defend a case. I suggest that you persistently demand the best medical care that you are entitled to. I called my insurance company about once a week. I also insisted that everything they told me be put in writing "for my attorney". Keep fighting! It is worth it! It has only been two and a half weeks since my surgery, but it has already been a life altering event! Good luck!

[BB]

The FDA has approved a limited number of multi level ADR replacements (in US). I had a 3 level Pro Disc replacement in 06 via Delamarter. The FDA approved the survey under the terms of compassionate surgery (Delamarter wrote a letter to the FDA). Aetna approved and paid for all but $3000.00 of the surgery.

[JJames]

The FDA has approved a limited number of multi level ADR replacements (in US). I had a 3 level Pro Disc replacement in 06 via Delamarter. The FDA approved the survey under the terms of compassionate surgery (Delamarter wrote a letter to the FDA). Aetna approved and paid for all but $3000.00 of the surgery.

I'd be happy to find a surgeon who I'd describe as "compassionate" at this point! My insurance provider network is even Aetna too, but they wouldn't budge on approving my surgery. Anyone I've contacted at the FDA has been useless. The only contacts I've found who even "sound" like they have any compassion is Synthes, the ProDisc manufacturer, and that's likely only due to the fact that they stand to make money if I'm granted the surgery.

It simply makes me sick to pay about $100/week for medical insurance and be denied a treatment which a surgeon claims has (or had, as my condition has been worsening) a 90% chance of correcting the issues causing so much daily pain and strife in my life. :rant:

[BB]

I believe it is all in the way the code is submitted to Aetna. My first disc was coded as Prodisc and the second and third disc were coded off label.. I was not part of the trial and I would think that Aetna would pay for the surgery. May be worth a visit to Delamarter.

[ezekiel]

Any word on the status of multi-level lumbar ADR? I've also been hanging on to the hope that just maybe, the next month it will be approved here in the the states.

Any updates would be great. Thanks.