Thank 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!

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???

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 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

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slackwater_sf

multi level ADR in U.S with FDA approval
 

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

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.

Keep fighting insurance company
 

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!

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.

Tough to find any "compassion"!
 

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:

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.

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.