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 !
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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???
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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.
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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?
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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.
