3-level cervical in 2004 w/Dr. Delamarter?
 

I copied some posts (check below) from the following thread in 2005. http://www.adrsupport.org/forums/showthread.php?t=7827 Part of it pertains to cervical ADR and paulam310 a senior member getting a BC PPO to pay for his surgery. Dr. Delamarter at St.John's, Santa Monica, performed the 3-level 4 yrs ago


I haven't been able to find other posts that explain this. Does Delamarter have special powers, how is this possible? Do insurance companies pay for surgeries before they are FDA approved under "research"?

When I contacted Dr. Delamarter's office in January, 2008, I was told that he could do a 3-level. Had to call the business department for a quote, $140,000 +or - , plus travel and accommodations from Ohio/Calif (the Dr. and device prices had been set, but the hospital hadn't finalized their costs). Also told probably couldn't get insurance coverage since ProDisc-C was only FDA approved for 1 level. I'm on Medicare and BC/BC Anthem as secondary. I had no choice but to choose Germany. Am glad since after discogram it was determined I needed 4-levels. Surgery in Germany cost approx 42,000 Euro's or $67,000 (bad exchange rate of 1.55+ in March 2008) not including travel and accommodations.

Can anyone explain why paulam was able to get coverage way back in 2004 and how could he have gotten a 3-level cervical at that time? There are some 3-level cervicals being done today in Seattle and Santa Monica, with special approvals from FDA. I don't understand? His last post was in April, 2004. Has anyone PM'd him to find out how he is after 4 years. Harrison, is this something you could check for us multiple cervies?

Read today's new threads about cervical costs. I agree since the quote I got for 3 with Delamarter was much higher. Maybe with more doing the surgery the lower the price? free market working?

Sandy

Well in 2004 I don't think this surgery was FDA approved, so Delamarter's office could've been doing it for free. Typically what happens is the doctor's office tries to approve the surgery with your insurance. SInce the procedure isn't typcially covered by the insurance company the manufacturer of the device will end up paying the doctor and the hospital, thereby making the surgery free. This only applies to FDA trials.

Of course, in 2004 the known issues with Charitie gaming the FDA trials hadn't been discovered or at least advertised. The insurance company could've really been covering this surgery for a small period of time until they realized the cost risks.



Delamarter is the last free doctor in LA. In fact he doesn't accept insurance at all. He takes your cash and bills your insurance later. Your insurance company will reimburse you whatever they feel like. Not a situation to be in if you're not rich. Another popular person, Dr. Regan, does the same.

prodisc-c and insurance
 

Makes sense. But a 3-level wasn't part of the protocol in the trials, don't know whether the FDA lets a doctor go outside the trial rules. Delamarter must have a "friend." There are lots of wealthy people around LA so guess he can charge what the market will bear.

Huh? Can you fill me in on what you are referring to? I read an old article on here not to long ago, that referred to the Pro-Disc trials possibly being skewed. Just curious if you are referring to something similar. Thanks, Kathy

Zorro, there are many perspectives on the overall design of the Charite clinical trial. I've heard many from patients (here), patients (phone) and of course from papers and at conferences.

My opinion is that for properly qualified patients, ADR is a good option. The qualification process continues to be the weakest link in the process. And that may have been a big part challenge in the original clinical design. If you really do your homework, you will see that (published) clinical design criteria is getting more careful; more detailed; more stringent. I think is a good thing, though some people may be disappointed to be disqualified from a trial.

Dr. Geisler published this interesting paper which provides a more analytical assessment of the Charité trial data than what was previously published. It's a bit technical, now old news, but read it carefully. I'll send it to you -- just email me (not private message).

Surgical Treatment for Discogenic Low-Back Pain:
Lumbar Arthroplasty Results in Superior Pain Reduction
and Disability Level Improvement Compared With Lumbar Fusion
Fred H. Geisler, MD, PhD

Sandy,

I was part of a clinical trial out of Delemarter's medical practice although with a different surgeon. Perhaps the person you referred to was part of a clinical trial as well? If that is the case then insurance would be billed as they would for a standard fusion, and the actual ADR device would be paid for as part of the trial. That's how it worked in my case at least. I ended up with a fusion anyways so it was covered like any other surgery. But had I been randomized for the ADR's my insurance would not have seen any different costs... it would have been absorbed through the trial itself.

I got insurance approval without any issues...

later trials have more rigid parameters?
 

I think I understand what you are saying. In early trials, multiple levels were done and submitted to the insurance company as fusion with cost of device, instruments, etc. paid by the manufactuer. Then after those trials, the FDA didn't approve??? So later trials were set up with tighter parameters, no multiples? Once the devices are "approved" by the FDA the doctors can't bill the insurance company for a fusion and let you pay for the devices as was possible in the trials?

I don't understand why insurance companies are not forced to pay for FDA approvals by the government. I understand why they don't want to pay -$$$. But what would be so wrong with their paying the amount that would be charged for a fusion and the patient paying for the extras. Both surgeries should be close to the same amount, except for the cost of the implants. :confused: :( :insane:

Sandy

Believe me I understand the confusion your feeling. ADR's are (for the right patient) the single best option for repair of the spine and yet an insurance company can dictate the type of medical treatment the patient will be provided. It's nuts !

The early trials were for a particular manufacturer's device.. FDA approval was pending for that device and other manufacturer's devices started their own trials.

Later trials were by other manufacturers.... and they all set their own criteria for patient acceptance. My clinical trial was for the Mobi-C and that trial definitely looked at 2 level ADR replacement, that's why they wanted me in the study as I had 2 levels that were shot.

As far as insurance approval went (for me) as part of the trial.... the only thing the doctors submitted for was a 2 level fusion (standard repair-nothing fancy) and my insurance approved the surgery very quickly. My trial was randomized, I didn't know when I was being put under what type of repair I had been randomized for... Once I woke up from the anesthesia I was told they had done a 2 level fusion, as that was what I was randomized for (randomization is done by an outside company, even the MD isn't notified until the patient is in the OR).

Had I gotten the ADR's the insurance company would still only have been billed for the surgical time and it's my understanding that it would have been less money for them in that event because the ADR's take less time to perform.

Working under the investigational device that clinical trials are done with, gives a bit of leeway on how they can be billed due to the randomization that is required. Once there is FDA approval, then the procedure that is done has it's own billing code and is defined differently. At that point my understanding is yes, the insurance company can "choose" to deny payment for that procedure... when there is another procedure that will fix the problem with similar outcomes.

In reading the boards here , what I have seen, are those that have gotten insurance approval have done so based on the cost of the original procedure done AND being able to show the cost of ADR placement being less usually due to less hospital time required post op for many patients. And the actual procedure time being less in many cases.

Keep in mind, insurance companies are all about the costs... it has nothing to do with the quality of the procedure or the long term outcome for the patient. Sadly enough :(

Medical implants are a huge issue (cost) for insurance companies. Working in health care as I did I had a little dealing with the billing aspects of these. And the negotiations that went in to devices (Hips, ankles, knees) between hospitals and insurance companies were hotly contested events.

It also appears (and I'm no expert by any means) that the insurance companies have had time with ADR's (TDR's) to get their ducks in a row. ALL of them seem to have the same policy on the devices. :sus: