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Matthew Cooperberg: Hi, I'm Matt Cooperberg. Welcome to another installment of the UroToday Localized Prostate Cancer Center of Excellence Interview Series, coming live from the AUA in Chicago, 2023. It is a pleasure today to be joined by Mike Leapman who is Associate Professor of Urology at Yale University and truly one of our rising stars in health services research, and the burgeoning field of implementation science, and has done some really fantastic innovative work in health utilization around novel technologies, and the impact of evolving payment models. Michael, welcome.

Michael Leapman: Thanks so much. It's a pleasure to be here. Great to see you. 

Matthew Cooperberg: Tell us a little bit about your work and what you've been doing. Maybe, starting with the work on use of genomic tests, and imaging, and what we're learning about national practice patterns.

Michael Leapman: Well, thank you, Matt. Yeah. The inspiration for this work is the understanding that there's really been this new generation of tools that have come out onto the scene and the natural question is how are they being used? Who is using them and who's receiving them? What we've done is looked at various different administrative data sets to understand national and regional utilization. Really in two directions. One, looking at multiparametric MRI, the other looking at tissue based gene expression tests. Some of the interesting work looking at genomic testing in the Blue Cross Blue Shield dataset, so a large administrative dataset of commercial healthcare beneficiaries. It's really striking the amount of small area level variation that we saw. We see this everywhere in healthcare and we would not expect that prostate cancer is any exception, but what's really striking is the rate and the adoption of utilization. We use the technique called group-based trajectory modeling to map out the trajectory and to understand why might a certain region adopt testing more often than others.
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Matthew Cooperberg: What about those why questions? In your paper you had the five strata of, quintiles of, adoption, but is this just... I forget the name of the model, but you've got the early adopters, then the second wave, then the middle of the curve, then you've got the stragglers, and then finally the few herds drag along.

Michael Leapman: Right.

Matthew Cooperberg: Is it that or is there actually regional factors that are driving them?

Michael Leapman: I think it really parallels other factors in prostate cancer, so the things that were significant were area level education, income, rates of screening, rates of treatment. Areas that are enriched for lots of urologists, lots of prostate cancer care that's really where the genomic testing is clustering. Those deserts, those areas where there's very little prostate cancer care one would also expect that there are deserts of advanced testing and advanced imaging.

Matthew Cooperberg: Do you find... It's a positive correlation. Do you find those that are using more tests are using more active surveillance less treatment?

Michael Leapman: Using more tests and also they do correlate with active surveillance. We've also looked applying the same framework looking at did areas that adopt testing more rapidly also change their use of active surveillance. There is a correlation, so they seem to go hand in hand. I don't think we can imply that adoption of MRI or genomics is making people do active surveillance, but they seem to go hand in hand.

Matthew Cooperberg: That is a huge causal question, because of course the purveyors of these tests would love to say that, "Yes, you're doing more genomic testing. Therefore, keeping them away from treatment." But, it may also be the fact that those on the early wave of genomics are also those...

Michael Leapman: Yes.

Matthew Cooperberg: ... that are adopting surveillance. Is there a way to tease this out with the methodology that you have at your disposal?

Michael Leapman: Yeah. That's right. That calls a question. We know that they're linked together, so to get at that causal question we have done some qualitative work, which does not answer definitively whether or not there's a difference. But, in interviewing patients and interviewing providers it is illuminating to understand what the patient experience is of having testing. It's not exhaustive. I don't think we can extrapolate this to all patients, but it does ring true that patients are understanding that they are getting a risk prediction. Consistently what we heard is having a low risk prediction or having an estimate that you have a 1% or 2% risk of dying of prostate cancer in 10 years is actually reassuring. It seems to reframe the question in ways that might be missed in the conventional way of talking about prostate cancer.

Matthew Cooperberg: We've also found that patients like pictures. That the imaging test might actually resonate better than the biomarker synthesis.

Michael Leapman: It's true. Yeah. Absolutely. Right. Genomics is abstract and patients often are confused about what genomic testing is. No matter how much we explain it to them and still... The most common misconception is that this is a genetic test that it measures some germline or an inherited risk that is deterministic of their outcome. There seems to be... These are effective and looking at the MRI can be helpful, but I think it has to be customized to the patient. There's some people where looking at an MRI image makes absolutely no sense and it can be distressing.

Matthew Cooperberg: What advice do you have for the companies to make these tests?

Michael Leapman: Yeah.

Matthew Cooperberg: It has always struck me that the science is done invariably in pretty tight collaboration with high profile academic institutions. The statistics are all very solid. The paper gets published and then the marketing department makes the report.

Michael Leapman: Right.

Matthew Cooperberg: There is a science of decision making that doesn't necessarily get brought to bear there. What is your sense of how we can be doing a better job presenting this information to patients in a way that helps them actually make better decisions?

Michael Leapman: Yeah. It's a wonderful question. I think that there should be a separate report. I think there should be a physician report, which has the distributions, the histograms, that information, and maybe patients can see both. I think, it would be a very important to have a very simplistic digest without confidence intervals, without small text references. We've heard consistently also that is confusing and overwhelming. I think, some patients may want to know what the 95% confidence interval of that estimate is, but I hazard to say that almost no one understands what that means or cares about it. I think simplicity is key. Relative descriptions high, medium, low, really seem to work.

Matthew Cooperberg: Well, then we have the current Prolaris report, basically, not only says high, medium, low, it tells you what to do, which is what patients want. I think, there's a lot of urologists that like that, but it's not really what the biology of the test allows this to really say.

Michael Leapman: Exactly. Right.

Matthew Cooperberg: How do you finesse that tension?

Michael Leapman: I think, it's tempting to go... That would be the... Of course, that would be very appealing to say you have to do that. I think people, we, should back away from making those prescriptive statements based on a genomic report, genomic assay, because we don't really know. If there was rigorous evidence that really did stratify outcome in surveillance, maybe, but we're not there yet.

Matthew Cooperberg: Coming back to the variation question. Obviously variation, excessive variation in and of itself is qualitatively a problem, but do you think the main take home is under use of testing in the deserts or overuse of testing in the high adopting areas? Or is it both?

Michael Leapman: I think, I'll take the easy answer.

Matthew Cooperberg: Yeah.

Michael Leapman: I really do think it's both. What is striking is there are some regions where there is truly excessive testing. Where almost a hundred percent of patients, regardless of risk strata, are getting genomic testing.

Matthew Cooperberg: Yeah.

Michael Leapman: Something's a little funny there. That can't be good and zero can't be the right answer, but it would be closer appropriateness. In fact, I've heard there are people who order all three assays for the same patient. Things like that happen.

Matthew Cooperberg: It's amazing to me the insurance companies pay no attention to this.

Michael Leapman: Right.

Matthew Cooperberg: Have you talked to the payers? In the course of getting these data, do you have conversations with any of those?

Michael Leapman: I have not, but that would be interesting. The cost-effectiveness question is of course relevant. I saw interesting data presented here that pathways involving genomic testing may be cost-effective if we really are backing away from intensive therapy. I think, the question is not settled. I don't know that just because the tests are expensive they may...

Matthew Cooperberg: If they really do what they're purporting to do you can buy a lot of genomic tests to avoid one round of IRT, or certainly proton therapy, or even one hospital admission for a biopsy infection.

Michael Leapman: Right.

Matthew Cooperberg: If they are actually driving behavior in the right way. How do you modulate it? How do you modulate the extremes toward a rational difference? In other words, are the deserts... The over testing, you would assume this is physician behavior whether or not there's an incentive there. Are the deserts due to lack of knowledge, lack of resources, is it financial barriers on the part of the patients?

Michael Leapman: Well, it's interesting because if you contrast MRI and genomics, MRI there is a local issue. If you don't have a 3T MRI or if you don't even have an MRI and you don't have skilled people to read it that's a resource issue. Theoretically, genomics is a send out test.

Matthew Cooperberg: Right.

Michael Leapman: No matter where you are if you have FedEx you should be able to send this out. I think, greater clarity in the guidelines. Right now, the guidelines it's great that they support the consideration of them, but that can be difficult to actually make sense of. Education, clearer guidelines.

Matthew Cooperberg: Shifting gears a little bit the other work that you've been doing, which is really cool and exciting is looking at the impact of private equity takeovers of urology practices.

Michael Leapman: Yeah.

Matthew Cooperberg: Where is the... First of all, where did the idea come from and what have you done with this so far?

Michael Leapman: Yeah. It's shifting gears, but I think it sort of speaks to the same question of changing wins and practice consolidation. I think, this is something that in certain markets really is a dominant force. Where there are massive consolidations in healthcare in general. This private equity question really came up, because if you look at trainees exiting practice that were exiting their training now some of the big questions are, where am I going to work? How is this going to affect healthcare? That was actually the organic origin story of this question as people looking at practices and saying, "Well, what is a private equity firm and what is this going to mean for me?" Of course, the natural question is, "What does it mean for our patients?" As there are inroads of large financial players into the healthcare world.

Matthew Cooperberg: I guess, to start with where did this idea come from to start looking at the impact of consolidation, and of purchase, and what have you found so far?

Michael Leapman: Yeah. It certainly came as a natural question from our trainees who are entering the job market and were curious and concerned about changing winds. We really approached this from a platform naive and an open mind. Say, "What is the landscape?" We started basically doing a healthcare market analysis. Looking at characterizing patterns of acquisition over the past five years. Credit to enterprising medical students like Walter Tsang and James Nye who are UCSF residents now, and a large army of students who helped carry out this work. Really doing a very deep dive into the nature of these transactions. We basically mapped out private equity and all healthcare consolidations in urology since over the past 10 years. Noted that really the main dominant trend over the past five years is private equity backed consolidation.

Matthew Cooperberg: What does this do to a market?

Michael Leapman: What does it do to a market?

Matthew Cooperberg: What does it do to a urology market? Are you at the point where you can say anything about that?

Michael Leapman: Well, what we found is that they're highly regionally specific. It is a national phenomenon, but these acquisitions are very targeted to certain areas. That plays to general strategy. In certain markets like New Jersey, Maryland they're much stronger imprints of private equity. Then that also raises the question, "Well, what happens to medical care in the wake of practice consolidation?" As we started to look at that question in the Medicare population looking at patient volume and Medicare spending. Interestingly, we found that pre-post comparisons looking after a practice or after a physician is acquired by a private equity group Medicare billing does go up and patient volume goes up. Interestingly, in doing an interrupted time series analysis when accounting for the fact that there was rising trends before the acquisition it actually was not significant.

Matthew Cooperberg: Interesting.

Michael Leapman: It seems a long-winded way of saying that these groups that are acquired are not done at random. They tend to be groups that are already expanding. These are busier practices to begin with. We didn't find, at least, a clear before and after effect.

Matthew Cooperberg: There's a poster here from Pittsburgh from Ben Davies Group, one of his med students, raising the concern, I think, looking at similar data, that this is going to increase disparities in access to care. Do you have the same concerns?

Michael Leapman: Yeah. A related study that we did is we did a secret shopper study where we contacted urology practices and cancer practices in general to understand availability of patients with Medicaid. One of the really striking disparities in cancer care and prostate cancer care is based on insurance.

Matthew Cooperberg: Of course.

Michael Leapman: If you have Medicaid it's much harder to get into any doctor's office and the urologist's office. We found that private equity owned practices saw substantially fewer patients with Medicaid compared to non-private equity acquired. There is potential, of course, with financial imperatives and incentives that it may widen that gap.

Matthew Cooperberg: Did you see that as a pre-post? Pre-post acquisition?

Michael Leapman: We did not do a pre-post for that.

Matthew Cooperberg: Okay.

Michael Leapman: It was sort of just a one time period.

Matthew Cooperberg: Yeah.

Michael Leapman: It's true. This may not be a pre-post. In fact, we can't say that the acquisition is what caused that that.

Matthew Cooperberg: Right.

Michael Leapman: But, the groups that are presently private equity affiliated had lower Medicaid access.

Matthew Cooperberg: Yeah. Last question, you're working in implementation science. Maybe, define the term a little bit for the audience. I'm curious what has excited you most at this meeting so far in that domain?

Michael Leapman: Implementation science is really about moving clinical evidence into practice. That evidence practice gap is very pernicious and present in medicine. I think, what's really striking about it is it's so hard to come up with and generate new evidence to do a trial to move the ball forward. It really is about changing behavior through systematized and scientific approaches. I think, the active surveillance debate really is, which what I just came off of is fresh in my mind, a field that may be ripe for that. It's about subtly moving human behavior. At the end of the day we can generate all the evidence, we can have the right drugs, we can have the right targets and interventions, but we ultimately need to move patients and providers in the right direction.

Matthew Cooperberg: Super. I think that's a great place to conclude.

Michael Leapman: Great.

Matthew Cooperberg: Thanks so much for joining us.

Michael Leapman: Thanks you so much. Yeah.