EP382: Pharma Conflicts of Interest and the Anti-Kickback Statute, With Aaron Mitchell, MD, MPH

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 could help humans live better lives if Pharma takes the advice of the right thought leaders and helps to disseminate their teachings.

Maybe physician societies could fill this role, but a lot of times, who needs educated are not the actual doctors in the society in question. It’s other doctors the patient is seeing who don’t realize the root cause is a GI problem or CKD (chronic kidney disease) until the patient needs a liver transplant or “crashes” into dialysis in the ER.

But irrespective of the validity of my musings here, the point is to quantify the in-aggregate “good” that might happen as a result of Pharma paying appropriate clinical experts appropriate amounts.

Contrast that aggregate good against some not so good. Study findings that Pharma can drive up not only Rx’s (prescriptions) for its own drugs but also drugs in general when they buy stuff for doctors or pay doctors. Patient populations get overmedicated when compared to a baseline as a result. Too many patients get diagnosed and treated for some condition that they may not actually have. Too many expensive me-too drugs get prescribed at big unnecessary costs to patients, taxpayers, and employers. When I say costs to patients, by the way, I also might be implying a clinical overtone here as much as a financial one, because there’s almost no drug that comes without side effects.

So, what are some solutions that Dr. Aaron Mitchell mentions in this episode, or I that bring up, if we are trying to steer physician payments into the aggregate good zone and out of the bad COI zone? Here we go, and these are not necessarily in the order in which they are discussed:

1. Keep an eye on practice patterns and overall costs. This might make physicians aware when their clinical decision-making is getting swayed, so to speak.
2. Get payers involved. Listen to this whole episode for the “how” and “why” here, but if anyone has a visceral reaction to this, here’s one possible positive from a physician standpoint: It could be a way to get rid of a lot of PAs (prior auths). If a doc’s practice pattern is average, on trend, and/or they do not take industry dollars, then they get what amounts to a PA gold card. With that carrot, a doc may have less inclination to let their prescribing decisions sway and/or take pharma dollars.
3. The federal government can get involved in a few ways that Dr. Mitchell talks about. One of them is a direct ban on all payments. Or maybe they could just clarify what is okay and what is not okay, since what is listed as COI in the current AKS is also currently considered an industry norm.
4. Asking providers themselves to pay attention and self-regulate and to, for example, not accept speaking gigs where they are paid to talk to an empty room or “consult” on topics that really they should know they’re not thought leaders in.

You can learn more at Dr. Mitchell’s personal profile on the Memorial Sloan Kettering Cancer Center Web site.

You can also connect with Dr. Mitchell on Twitter at @TheWonkologist.

Aaron Mitchell, MD, MPH, is a practicing medical oncologist and health services researcher. He is an assistant attending at Memorial Sloan Kettering Cancer Center in the department of epidemiology and biostatistics. His research focuses on understanding how the financial incentives in the healthcare system affect physician practice patterns and care delivery to cancer patients. He cares for patients with prostate and bladder cancer.

07:32 How does the recent whistleblower case serve as a good example of what shouldn’t be permissible in Pharma?

11:23 “There’s a little bit of a disconnect between what the law currently says and maybe the ideal world that we would want.”

11:56 Dr. Aaron Mitchell’s paper in the Journal of Health Politics, Policy and Law, titled “Industry Payments to Physicians Are Kickbacks: How Should Stakeholders Respond?”

14:37 How should stakeholders react to this new legislation?

17:56 What is the aggregate benefit versus risk of these payments to doctors?

19:53 BMJ paper by Tyler Greenway and Joseph Ross.

23:51 What should providers and the federal government be doing in light of this new legislation?

29:07 “It’s just always so much harder to get to the outcomes because there’s so much more that happens in between the clinical decision and then what the patient’s outcome is down the road.”

30:42 Will innovation be stifled with this new crackdown on kickbacks?

You can learn more at Dr. Mitchell’s personal profile on the Memorial Sloan Kettering Cancer Center Web site.

You can also connect with Dr. Mitchell on Twitter at @TheWonkologist.