Please Help me.

[Nichole]

My name is Nichole, a 32 year old single mother living in Seattle, WA. Approximately 2 � years ago I sustained an injury to my lower back during a softball game, which left me unable to move for several days. After numerous visits to the doctor I was informed that I had herniated my L5-S1 disc and there is also a tear in the annulus which would never heal. I underwent 2 MRI�s, 3 spinal injections, visited 3 separate physical therapy clinics, and suffered through 2 Discograms. None of these minimized my pain which brought me to Dr. Schwaegler for an Orthopedic surgery consultation. I was informed that as of that day the only thing that could be done was to fuse the spine, which, in time, I would lose the mobility in my back and could experience several other complications along the way. My doctor agreed I both agreed that at my age it was a sad choice. By the time I was 37, I could possibly be moving around like I was 90.

After much discussion about the fusion he told me of a disc replacement procedure that they had been doing in Europe for the past 17 years called the Artificial Disc Replacement surgery. Europeans have had great success with this surgery. Both in the short term as well as long term. Dr. Schwaegler stated that I was a perfect candidate for this procedure due to age, weight and type of injury but unfortunately it had not been approved by the FDA yet....

After doing numerous hours of research on this, following the FDA on a monthly basis and contacting Depuy (the manufacturer of the Charite disc), I received and email in November of 2004. The FDA approved the procedure! The manufacturer of the disc sent me an e-mail personally due to the interest I had shown in having this done, to give me the good news.

I have been on a daily regiment of medications since the injury to maintain anything resembling a normal life. If I forget my medication for even one day, I am immobile and am in so much pain that sleep is not an option. I am unable to stand long enough to do dishes, laundry, normal day to day functions, and the hardest limitation is playing with my 12-year-old son.

Due to the procedure being approved by the FDA it is no longer an �experimental� procedure. However, as Dr. Schwaeglers patient representative has tried to get authorization for me to have this surgery and my insurance company, Regene, is denying this surgery stating that the procedure is �experimental�. They do not want to pay for this surgery. However if I was to go out of state they would pay at 80% and without authorization. I was also very confused when I was told that a very small insurance company in Bellevue is approving their patients to have this surgery but a big insurance company like Regence is not.

The problem is that the insurance companies do not look at these issues from a patients prospective. I can go ahead and have the spinal fusion and my insurance will pay 100% of the costs to have that surgery. In approving me to have a spinal fusion they also �silently� approve all of the medical complications that will come later in life for me due to having the spinal fusion, such as fusions in the rest of my vertebrae to make up for the loss of mobility in the level that would be fused.

The reason that I am writing this letter to you, is I know that there are numerous patients out there that are just waiting, in sever pain for the insurance companies to quit playing their denial game and allow the patients to have this surgery. At some point this surgery will be approved by all insurance companies as the Total Knee replacement has and the Total Hip replacement surgery.

I obviously have a personal interest in helping this process along. I would like to play ball with my son, take the dog for a walk, sit in a chair for more that 20 minutes at a time, and just have a normal quality of life.

If anyone can give some advice on how to get my insurance to cover this please let me know. I dont know how much longer I can hold on.

Thank you.

[bmills]

Nichole, I may have something for you. I am in a similar situation. DDD and bulging in L5/S1 for many years.

I am seeing a Doctor Kenneth Pettine in Loveland Colorado. He co-invented the Maverick ADR. He has done both Maverick and Charite ADR implants. He says there is a study starting to compare the Charite and Maverick. I believe this is in March. If you enroll you have to agree to receive either the Charite or the Maverick in a drawing. I am considering this depending on the results from my discogram this Tuesday.

If this helps or you want the Doctor's info let me know. He does seem like a good doctor. He has done 500 anterior fusions, about 13 Mavericks and about 13 Charites so far. I talked to one patient of his that has the Maverick and she had a great 100% recover very quickly.

Brady
Considering ADR

[Jim M2]

Nichole,
Sorry to hear about your pain. The Charite is no longer an experimental surgery. It was approved by the FDA in 2004. Your insurance company has been misled or they haven't updated their records yet. Remind them a fusion would be double the cost.

Dr. Jay Williams will be performing the Charite surgery in Seattle. Look for him at this link.

http://www.proliancesurgeons.com/594.html

I had L5S1 Charite surgery in Europe. After returning to the US I was under Dr. Williams' care until I moved away from Seattle last year. He's knows the technology and he's very good at explaining things. Please go see him (top floor of Nordstrom building on Pill Hill).

All the best,
Jim

[Harrison]

Hey Nichole, I emailed you before reading this. Any way, Jim is right, the Charite' (which I have) was approved in October of last year, see the FDA press release here.

Also, do a search on this board using "insurance," there are several key threads on this topic, and some very helpful ones coming soon from a member who has a legal background and a recent win with her appeal against Athena!

[bmills]

I will have to research the insurance too. My Cigna HMO is still not approving them.

Also, Jim, can I talk to you about your Charite'? How do you prefer to get in contact?

Thanks.
Brady
Considering ADR L5/S1

[Nichole]

I am aware that the disc has been approved. I have been in close contact with the manufacturer. I received a phone call the day it was approved. However, the insurance companies done care. They are saying it is still investigational. Dr. Schwaegler is also performing this surgery in Seattle. He is one of 100 doctors in the USA who will be instructors for this surgery. So he is a very competent suergon. However he is also having problems with the insuracne companies. I know Dr. Williams very well also. He is also having the same problems with the insurance companies. Dr. Schwaegler sent a 84 page appeal on my behalf to Regence. It was filled with all information from the manufacturer and etc. They are denying due to they want long term information on the disc. They said and I quote "Total disc replacement appears to be associated with a high rate of re-operations, and the potential problems that may occur with longer follow-up have not been addressed. Thus, total disc replacements should be considered experimental procedures and should only be used in strict clinical trials". I am not sure what I can say to them or what documentation I can get to change their minds on this.

Please help.

Nichole

[Harrison]

Nichole, pls see the Charite' study here, which is quite reputable!

http://www.adrsupport.org/content.asp?cid=198

[Jim M2]

Nichole,
You're well informed on the local doctors!

It surprises me that insurance companys can cherry pick among approved FDA procedures. How can they fair mindedly propose that an approved FDA procedure is experimental? It seems to be an arbitary opinion motivated by profit incentive. By the same thinking they could extend their argument to deny any medical procedure!

An insurance insider gave me some steps for appeals.
***
1) submit to the insurance company a "letter of medical necessity" on your behalf from a US specialist such as neuro or ortho surgeon. Letter should state what surgery is needed and why. submit supporting documents such as radiologists reports, doctor visit notes and the like. Request that they response in writing.

2) If they reject the appeal then you submit all documents, including their rejection, to your state's insurance commission. Attempt to get the state on your side. Once you get the state involved the PPO will supposedly fold. The entire process takes about 6 months.

The PPO may have a patient advocate. The PPO is obligated to tell you who this is. This person may help state your case.
***

Back to my situation as an example. I had ADR in Europe in 2003. After the surgery I submitted according to step 1 above and was reimbursed 90% of medical costs. Didn't have to do step 2. I would think the same process is worth a try for preapproval.

It's a shame you have to deal with this. I wish you luck. I hope you're having a low pain day.

Take care,
Jim

[Nichole]

Thank you Jim for the great advice. I will do just that. I am now at my second level of appeal and am going to request that appeal to be an inperson appeal. I will be bringing my Doctor who is an Orthopedic Suregon, his assistant, and we are also trying to get a representative from Charite' to fly out to attend as well. I am going to also in the meantime (after the recommendation from Richard) contact an attorney who speacializes with insurance issues. I also will be doing some research on ERISA to see if I can find some information to help my appeal process. I am going to do whatever it takes to win this battle and will post any and all information that has helped along the way. Hopefully I can help someone else as you are all helping me.

Thank you Richard for you help today! I cant tell you how much it means to me to have all of you on my side with the love and support. It helps me get through my painful days with hope.

Nichole

[queenofhearts]

Nichole - I sent you a PM about ERISA with some links (actually 2 messages - I forgot the links in the first one).

My insurance company denied my surgery claim twice (once pre-op and another post-op), but I won on appeal and they reimbursed me 90% of all costs.

Let me know if I can help - I'm in the Seattle area.