Clinical trials and medical insurance coverage
 

Over the past few months, I have been in touch with Sloan Kettering in NYC regarding their Phase I vaccine trial for stage 111 and stage IV HER2 positive bc. I just completed the ct scans that were required and was to meet with the doctor last friday for bloodwork. Late last Thursday the office called and cancelled the appointment stating that the doctor was afraid to administer the vaccine because my insurance company would not cover any hospitalization or medical expenses if I had a severe reaction to the vaccine.

I was just wondering if any of you had similar problems when participating in the vaccine trials at U of Washington.

The research subject information and consent form that a patient reviews and signs to participate in clinical trials should have some information to indicate what adverse situations are supposed to be covered by the clinical trial. What does the clinical trial form you signed say about it? If the problem clearly is due to your participation in the trial and your form says the trial is supposed to pay for that, then that would be how it would be covered.

However, if you are in the trial and something happens that falls into a gray area where it could be due to the trial but it really isn't clear what caused the problem, then you could run into problems if your health insurance declines to pay as well.

I've participated in several clinical trials. For one of them I did all the prequalifying exams and blood samples and then asked about the "gray" area. (In fairness to both the trial and myself I should have asked this before I did the prequalifying exams.) The clinical trial coordinator explained to me that each situation was unique and would be reviewed by the trial investigators if and when it happened before being approved for coverage by the trial sponsor.

As a patient I want to be part of the clinical trial process for any solutions that I think might help us all. But at the same time, in this situation I wanted some reasonable written guidelines for the process that they would follow for anything that fell into a gray area so that I would have something on paper to use in dealing with my insurance company that was fair and reasonable to them too. I wasn't able to get any guidelines from the clinical trial, so I dropped out.

I suspect that in my situation the lack of more specific guidelines was unintentional and was simply something that not enough clinical trial participants ask for, or we would be given them. Most of the time participants are so eager (read that, desperate) to get into clinical trials, with not much in the way of alternatives, that it goes by the wayside. In all of our best interests we should still ask for those guidelines.

But I have worked too hard for my insurance coverage for too many years, and I was not in a situation of being desperate. So I provided them with a message about the need for written guidelines by declining to participate. They lost one very willing participant AFTER completion of all the testing simply because they did not provide written guidelines to me that I could use with my insurance company if a problem came up.

AlaskaAngel