I was billed for my recent biopsy but evidently that was in error and charges will be reversed. On Tuesday I sat down with my research coordinator and we went through the procedures one by one to break down what was billed to insurance, and what was covered by the sponsor.
So here goes. Considered standard of care (and therefore billable) are these items:
Blood work that is CBC (complete blood count) with DIFF or differential
Blood work that is comprehensive metabolic
CT scans that fall within SOC schedule (every twelve weeks)
And these are the procedures that are considered research only and which are expenses picked up by the sponsor of the trial:
Pharmacokinetics or PKs (all other labwork)
CT scans done more frequently than every twelve weeks
And so it is not as bad as I imagined per expenses expected to be covered by me, the participant. However, the language in the consent form is exceedingly vague (Standard of care versus research) and I would urge anyone participating in a clinical trial to have it spelled out ahead of time.
I would also point out that my travel, lodging (back to back late evenings with early morning appointments the next day sometimes make this necessary), meals and parking are still picked up by me. This is no small potatoes in a trial that had me at the hospital four out of seven days last week. In addition, should I suffer a side effect related to trial, any subsequent treatment shall be billed to insurance: ‘The treating hospital will offer you the care needed to treat injuries directly resulting from taking part in this research. These treatments will be billed to your insurance company. You will be responsible for deductibles and co-payments. There are no plans to pay you or give you compensation for your injury.’
It is good to know that the biopsy was not correctly billed to me which would have been insult to injury. However I am still angry that I am required to effectively donate tissue from an exceedingly invasive procedure (not once, but twice–and they had asked for a voluntary third biopsy). Evidently a small core sample was obtained for MGH and it was sent to pathology confirming cancer cells were present (duh). However, there is not enough tissue to, say, make mouse models. Or to run genetic sequencing with tissue to spare should it be needed later. Both of those things would be helpful in a complicated case like mine–three known secondary acquired mutations conferring resistance. The sponsor got the bulk of the tissue–any effort to acquire more would have been considered risky to me.
In the consent form I signed it is acknowledged that performing a biopsy comes with associated risks including this little nugget “There is risk of regional spread of cancer cells when the needle is removed from your tumor. Although very rare, there is a risk of serious complications (such as pneumothorax)…and death.”
Yeah, death does sound serious. But so does regional spread of cancer cells. Essentially the sponsor is paying for a piece of me, not an optional piece, but a required piece. I am glad that there is not associated financial burden but the physical burden is still huge. And if someone is going to be harvesting my tissue, well then by all means they should share that bounty with me, so that I too can benefit from my sacrifice.
Bottom line, ask questions, lots of questions. Of course it is difficult to ask what you don’t know, and even though this is my fourth trial, I am still learning. I would also suggest that consent forms could be much better at spelling things out–as they stand now, there are just too many vagaries.
Ultimately, I want some of my tissue. And a net zero balance per my expenses related to participation. I do not feel this is too much to ask. In an ideal world I would also be compensated for my time.
Just as astronauts are. 🙂
Hoping for a great outcome as you pioneer this new frontier
Linnea, I am aware of much of this as you have related this to me in the past. However… Any rational individual (note “Any”) can clearly see that EVERYTHING done, required or performed of/on/in you IS the the trial! Hard to believe that they separate any of this. Keep up the fight!❤️✊🏼