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EP382: Pharma Conflicts of Interest and the Anti-Kickback Statute, With Aaron Mitchell, MD, MPH
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I saw a Tweet from Farzad Mostashari, MD, the other day; and I'm gonna rewrite it in the context of today's show:
This is why we can't have nice things! As soon as someone comes up with something that might accomplish some good things when done in moderation and with good intent, it gets exploited for revenue maximization.
I have to admit, this conversation with Aaron Mitchell, MD, MPH, and actually the one with Mark Miller, PhD (EP380), from two episodes ago were both kind of painful for me—and let me tell you why. It's the same reason I find conversations painful about hospitals or leading cancer centers or even some self-insured employers and EBCs (employee benefit consultants): It hurts my heart when some percentage of healthcare industry peeps who have the opportunity to produce so much good in the world instead choose to do stuff that is financially or otherwise toxic.
But let me get to the point of today's show. Dr. Aaron Mitchell and I are talking about conflicts of interest (COI), and we're talking about COI in the payments that are made from Pharma to physicians. COI might mean when physicians are paid in a way that skews their clinical decision-making. Nobody wants to be the patient of a physician with skewed decision-making, after all. That's the "why" of this whole discourse.
Now, let's get into two important points re: skewed decision-making. Any payment that skews decision-making is, in fact, considered no bueno by the current writing of the AKS, the anti-kickback statute. Second, almost any payment, direct or indirect, turns out, skews physician decision-making.
It's not just getting paid the big bucks to make a speech or consult or whatever. Getting a modest free lunch can also have the same effect. Prescribing is affected. That's what the data show and what the recent paper that Dr. Aaron Mitchell and his colleagues published in the Journal of Health Politics, Policy and Law articulates. Their paper is titled "Industry Payments to Physicians Are Kickbacks: How Should Stakeholders Respond?"
So, hmmm. Much to cogitate upon in what I just said, which is what the conversation with Dr. Aaron Mitchell that follows is all about. But let me offer up a few spoilers and maybe some additional thoughts.
First of all, some "Are payments COI and kickbacks?" contemplations are pretty black and white. We start out the conversation in this healthcare podcast talking about the recent Biogen incident, I guess I'll call it, which is sadly not an outlier. Biogen never admitted any wrongdoing here. But if what they are accused of doing is true, this could be considered not a gray area. This is black-and-white COI—unquestionably should not happen.
But where things get a little bit more open to interpretation and require some consideration and thoughtfulness is if we're trying to weigh the gray in the middle between black and white. Here, what needs to be thought through is the aggregate good versus the aggregate bad of Pharma paying physicians to do stuff or buying things for them. If Pharma needs help during its clinical trials to figure out a breakthrough therapy and they want to talk to leading experts in a specialty, that's maybe a good thing so that they can get a drug that actually works well for patients.
So is—and this is me talking, not Dr. Mitchell—but I could see that Pharma helping to figure out ways to educate clinicians about the best ways to help patients suffering with real diseases that nobody else is making any effort to do anything about at a national scale … it