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Episode 126
Duration 37:59

Scott Berkowitz: Value-Based Care and Population Health

Howie and Harlan are joined by Scott Berkowitz ’03, cardiologist and chief population health officer at Johns Hopkins Medicine, to discuss the necessity of moving from fee-for-service to value-based care delivery to improve outcomes for all. Harlan highlights the dangers of misinformation about Ivermectin. Howie reports on the potential conflicts of interest created by device manufacturers’ payments to cardiologists.

Links:

Johns Hopkins Medicine: Home

Johns Hopkins Community Health Partnership

“Association of a Care Coordination Model With Health Care Costs and Utilization”

“Planning for the Future of Population Health: The Johns Hopkins Medicine Experience”

“Califf’s long day on Capitol Hill”

“The FDA Deleted Its Viral Ivermectin Tweets. Now There’s Even More Misinformation.”

“Philly Nonprofit Awarded $48 Million to Apply AI in Search for New Uses for Approved Drugs

Posted on March 12, 2024”

“Effect of Early Treatment with Ivermectin among Patients with Covid-19”

“Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19”

“Effect of Higher-Dose Ivermectin for 6 Days vs Placebo on Time to Sustained Recovery in Outpatients With COVID-19”

“Systematic review and meta-analysis of ivermectin for treatment of COVID-19: evidence beyond the hype”

Ivermectin and Covid

“FDA settles lawsuit over ivermectin content that doctors claimed harmed their practice”

“Intravascular Microaxial Left Ventricular Assist Device Manufacturer Payments to Cardiologists and Use of Devices”

“Impact of Industry Payments on Prescribing Patterns for Tumor Necrosis Factor Inhibitors Among Medicare Beneficiaries”

Yale Innovation Summit 2024

Learn more about the MBA for Executives program at Yale SOM.

Email Howie and Harlan comments or questions.

Transcript

Harlan Krumholz: Welcome to Health & Veritas, I’m Harlan Krumholz.

Howard Forman: And I’m Howie Forman. We’re physicians and professors at Yale University. We’re trying to get closer to the truth about health and healthcare. We’re excited to welcome Dr. Scott Berkowitz today. But first, we like to check in on current hot topics in health and healthcare. So Harlan, what is on your mind?

Harlan Krumholz: Well, thanks, Howie. Of course, lots going on as usual. One of the things that happened recently was that our commissioner, Robert Califf, came to testify in front of Congress. And of all the important things that people can talk about in the congressional testimony, of all the kind of questions that you could pose to an FDA commissioner in this time of so many different issues going on, they started asking about ivermectin again.

Howard Forman: It’s insane.

Harlan Krumholz: Riddle me this, Howie. Why is it that people coalesce around certain things that actually have nothing to do with each other? So people who are anti-vaccine also coalesce around pro-ivermectin? It’s sort of that people are somehow attracted to these topics. And of course our presidential candidate, and I don’t want to say “our presidential candidate”—one of the presidential candidates—Robert F. Kennedy Jr. has made this a cause célèbre in addition to his anti-vaccine promotion, has been this promotion of, positively, of ivermectin. And why do those things go together?

Howard Forman: I mean, the only way I tie them together is there is a strong undercurrent in this country dating back to the Revolutionary War that is anti-government. We are, by nature, libertarian, or at least that’s how we were founded. And I think people are afraid of government. Reagan famously, and was proudly saying, I forget, the 11 most fearful words in the English language, “I’m from the government and I’m here to help.” And so the FDA becomes a very easy foil for that because they are involved in some of the weightiest decisions about things.

And for someone like RFK Jr. who for whatever reason has become staunchly anti-vaccine—and by the way, he says he’s not, but he is—it’s very easy to start to say the FDA is a sellout to private industry and they’re all about profit. And then if you get to that point, then you’re like, “Well, vaccines are bad because it’s really just about making money.” And ivermectin is good, because the FDA, it’s a very cheap drug, and the only reason why the FDA wants to keep it out of our hands is because it’s not making money for somebody. And it’s very disturbing, and all I can say to you, Harlan, is, the work that you do, that Joe Ross does, that others do, to help elevate the FDA is more important than ever before because of this.

Harlan Krumholz: Yeah, look, we don’t shield them from our...

Howard Forman: That’s my point.

Harlan Krumholz: ...suggestions about how they can improve, but we’re firmly behind them. I was on a panel with Rob Califf last week, and honestly I said that in the beginning, which was, that we should work to help the FDA improve, but we should recognize there are remarkable people working there, including the commissioner, but many people who’ve spent their careers devoted to public service there. And there’s not a conspiracy behind the FDA; they’re trying to do the right thing. I just wanted to note a few things. This ivermectin thing came up because the FDA came out with a tweet.

Howard Forman: Yes, the horse tweet.

Harlan Krumholz: Midway into the thing where they said, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” Because there had been reports of a lot of people using ivermectin, and it was not, in their opinion—and they looked at this closely—did not merit any sort of endorsement on the FDA side in terms of an expanded indication.

It is indicated for certain kinds of parasitic infections, and it is not a bad idea to look at medicines that exist and see whether they can be repurposed. And they have been, in many cases, repurposed to good effect. David Fajgenbaum, a friend, down at University of Pennsylvania, who’s just gotten an enormous amount of money, $50 million or more, from ARPA-H [Advanced Research Projects Agency for Health], to explore repurposing drugs for other effects. This is a good idea. Early in the pandemic people talked about this anti-parasitic medication as potentially having antiviral effects, or actually being demonstrated in vitro to have some—

Howard Forman: Yeah, and there was some evidence. I mean, there was some sort of, like you say, in vitro evidence, in a lab, that at certain levels it could be antiviral.

Harlan Krumholz: That’s right. So if you added ivermectin to a petri dish, you could see that it had some antiviral. So this wasn’t a crazy idea to try this, so as a result, there were many trials that were done. One published in The New England Journal of Medicine with over 3,500 patients were randomly assigned to receive ivermectin or placebo or another intervention. And conclusion, treatment with ivermectin did not result in lower incidence of medical admission to hospital or progression of COVID-19. An article funded by NIH that was in JAMA, similarly—effective ivermectin versus placebo on time to sustained recovery in outpatients with mild to moderate COVID. The conclusion was, among outpatients with mild to moderate COVID, treatment with ivermectin compared with placebo did not significantly improve time to recovery.

Some people took that study and said, “Well, they weren’t using the right dose.” This is unusual, but JAMA publishes later, “Effect of Higher-Dose Ivermectin for 6 Days vs Placebo on Time to Sustained Recovery.” Again, the same finding of nothing. A systematic review comes out in BMC Infectious Diseases in 2022, that they look at 25 randomized controlled trials that met their inclusion criteria and of different kinds comparisons, 14 specifically on ivermectin. And what they found was ivermectin does not reduce mortality risk or the risk of mechanical ventilation, which was the focus of their look.

Howard Forman: You and I are preaching to the choir, so to speak. And I’ll bet every single one of our listeners agrees with what you’re saying and what I agree with as well. We’re going to keep revisiting it. I mean, I wish that I, or you, had the confidence in someone like Joe Rogan to have a conversation with them because it’s his listeners that get most enamored. It’s Tim Pool’s listeners, it’s right-wing shock jocks who are most enamored of this topic.

Harlan Krumholz: Who are doing a disservice to their audience—

Howard Forman: Oh, for sure.

Harlan Krumholz: ...and the final thing here is, you and I both know there’s studies coming out now that states that are highly concentrated with people on the conservative side have suffered greater casualties from the pandemic.

Howard Forman: That’s right.

Harlan Krumholz: And I have to believe that a lot of that is because of the misinformation that was—

Howard Forman: I agree. Couldn’t agree more.

Harlan Krumholz: Anyway, we can go on. Hey, we’ve got a great guest today. We can do it. Great, let’s go.

Howard Forman: Dr. Scott Berkowitz is a cardiologist by training who serves as chief population health officer as well as the vice president of population health for Johns Hopkins Medicine. He’s trained in cardiology and gerontology and is steeped in the policy business and science of population health. Since his start at Hopkins in 2003, his career has revolved around healthcare delivery and healthcare transformation. He previously directed and administered the Johns Hopkins Community Health Partnership, was appointed the senior medical director for the Office of Johns Hopkins Physicians and led the Johns Hopkins Medicine Alliance for Patients as executive director. Aside from his many leadership roles in Baltimore, Dr. Berkowitz has also been active in shaping U.S. health care policy. He has advised the U.S. Senate Finance Committee as a fellow and worked with the governor of Illinois as a senior healthcare policy development advisor, to name just a few examples.

He earned his bachelor’s, MBA, and MD from Yale and was in the second class of our MD/MBA students before going on to Johns Hopkins as a cardiology and then geriatrics research fellow, after completing internal medicine. So first of all, welcome to the podcast. It’s really great to have you here. I want to start off, I think what our listeners need to appreciate is just the intentionality of your training. And I want to go back to the summer of 2002, when you actually worked for Senator Kennedy and the Health Educational Labor Pensions Committee of the U.S. Senate, and how that started to inform your interest in the intersection of policy and healthcare delivery.

Scott Berkowitz: Yeah, thank you so much Howie for that introduction, and Harlan, it’s wonderful to be with you both today. I really appreciate this. You’re right, Howie, that experience in the summer of 2002 in the Senate Health Committee was an important one and was a follow-up really to the opportunity that I had, as you named at the outset, to participate in the second cohort of the MD/MBA program. And so as I started in medical school, I increasingly became interested in the applications of clinical delivery and policy and how we can build and impact more populations than just those that we are seeing within our clinic or within the hospital, all of which is important, but I was interested in being able to do a little bit more and on a broader scale. And I found that the MBA program was an opportunity to grow my literacy in those areas of business and management, and the approach to being able to provide those services and clinical care delivery more broadly.

And a unique component of that program in between the fourth and fifth years of that educational experience was the opportunity to do an internship or a program or any other type of work opportunity. And fortunately, for me, it was able to come together to have that opportunity to be on the Hill, to work on Senator Kennedy’s HELP staff led by David Nexon, just an incredible group of staff leaders, public servants, who worked so hard. And really, Senator Kennedy was, as they say, a lion in advancing healthcare policy. And so yes, that was an incredible experience. I spent a few months on the Hill. That was my first federal government opportunity, and I believe, Howie, you may have been on the Hill as well, down the hallway.

Howard Forman: At the same time, yup.

Scott Berkowitz: And always continuing to be a mentor, for which I’ve been grateful. But yes, absolutely, I think that that was a great experience in being able to jump into what was Medicare Part D before it really was passed and became Medicare Part D. We did some work in smallpox policy as well as various other areas, cloning and other scientific areas of inquiry. But it really did help me to understand what it’s like and how policy can translate at broader levels that can really impact people.

Howard Forman: Fast-forward now, and you then do internal medicine, cardiology, a gerontology training. You are interrupted very briefly to go work in Illinois in a policy position. But when you return, at that point, the ACA is now about to be passed or it’s being written, the Affordable Care Act or Obamacare. Can you just speak to what your involvement was there and then how that started your career off? And I think that’ll lead nicely into some of the things Harlan wants to ask about.

Scott Berkowitz: Thanks, Howie. I was very excited at the opportunity to do my internal medicine residency training at Hopkins for many reasons, both clinically, as well as geographically and otherwise. And that was a great opportunity. You mentioned I took a one-year leave of absence and worked in state government. And then ultimately stayed on to do cardiology fellowship at Hopkins. And as you’re mentioning, that was right around the time of Obama’s election, and I really had a strong sense from what I was reading and understanding that health policy and health reform might be top of the agenda for early on in the administration, and had the opportunity through a lot of navigation to ultimately be able to find that opportunity to be a fellow on the Hill on the Senate Finance Committee, during the development of the Affordable Care Act.

And that group was... the chair of the finance committee was Senator Max Baucus. The leader of the health committee was Liz Fowler, who also has been a mentor and a great leader. And I had the opportunity to be a part of that team. I was, I would say, a minor part of that team in that the staff there, the professional staff, had been working for a long time on developing that and had a whole series of listening sessions and policy efforts. But I really felt like I was right in the middle of that development and that activity for the Senate. And then that Senate legislation that came through ultimately was the preponderance of what the final Affordable Care Act legislation was. And I was able to help contribute in my way and to help to bring that perspective of a physician-in-training into that process.

And I carried that experience with me and that interest when they were setting up the Innovation Center, when they were defining what an accountable care organization would be. I took those experiences and brought that with me to my next role and positioning at Hopkins as the medical director for accountable care, to try to see whether Hopkins and other academic medical centers would enter this fray of value-based care and what that would look like. And that was really where I entered on the ground floor, which is really as Hopkins was entering on the ground floor, in terms of value-based care and health reform.

Harlan Krumholz: You’ve really been a pioneer. Love it when a cardiologist, again, shows leadership in medicine writ large, and your scope has been quite broad and profound. And Baltimore, such a great place to focus efforts, lots of challenges, lots of opportunities. One of the things that really is, I think, impairing our ability to go forward is the way in which doctors are incentivized. At least at Yale still, we’re heavily over-indexing on relative value units. Which means that doctors get credit for some things to a large extent, particularly procedures, and not talking to patients or guiding them, and actually resisting doing things ends up often putting them at a financial disadvantage with regard to how the institution sees them.

We all get our P&Ls every month, for example. It just shows how much money did we generate from the patients that we got, and it focuses people’s attention intently on those areas that are reimbursed well. And honestly, within the institution, if you’re someone whose P&L, your profit and loss, doesn’t look good, you’ve got much less influence, much less latitude, much less freedom honestly within the institution. How are you thinking about this? I mean, how are we going to change this? Because there’s also all of that moral crisis within medicine where people feel that that soul-sucking has a lot to do with the idea that they’re being judged based on revenue generation rather than the health that they create among their patients. How are we going to get out of this fix?

Scott Berkowitz: Yeah, I think that’s an excellent question, Harlan, and a really important one there. There’s an expression in healthcare, which I know you all are familiar with, this idea of having your foot in two different canoes, where we have our foot in the fee-for-service canoe of continuing to provide fee-for-service care, as is still, in many geographies, the preponderance of care that is provided. While we have our other foot in this canoe of value, of trying to understand how you’re prioritizing delivery on quality and at the same trying to reduce unnecessary utilization and cost. And different areas are looking at this in different ways, but it’s real no matter where you are. So as an example, we experience that, and there’s different value-based care delivery vehicles. So for example, in Maryland, where is a major part of our footprint—not all of our footprint but a major part—there is a waiver that’s an all-payer waiver that’s been in place related to the government and the state to try to have global capitated budgets and a total cost of care metric across Medicare fee-for-service.

And so there is increasing movement within that geography to help to support value-based delivery and what that looks like. That doesn’t mean that we don’t, and I don’t, still receive reports that may reflect RVU [relative value unit] generation for certain services I provide as a cardiologist, and what that looks like in comparison to some of my partners or other physicians who might be in surgical subspecialties or other areas, who are also similarly looking at that. I think that is something we still need to look at because you still need to deliver services. So just as an example, access. We need to get people into cardiology access, primary care access, and other areas. So it is important that in your delivery of frontline cardiology or primary care or other care, that you can see people in clinic, that actually your clinic is full, seeing patients to help support them.

Harlan Krumholz: How do we continue to incentivize productivity and reward productivity but focus it on where there’s value and benefit for individual patients and maybe get away from this idea that it really is all about the procedures.

Scott Berkowitz: I think you’re raising several different issues, all of which are good. One of them is sort of the way in which more cognitive fields may relate to other surgical or procedural fields. But in the big-picture sense, I think the opportunity is to expose, in real terms, all members of the care delivery system to the idea of value. And that means having a certain set of quality metrics that are shared with you, that you’re trying to perform around, having a set of utilization metrics that capture and relate to your particular division or department because everyone contributes to this idea of a total cost of care. But people don’t necessarily know, to your point, the way in which they’re contributing. And that primary care tends to be a smaller fraction of that total cost of care, but the work that the surgical subspecialties, and everyone, is doing has to be a part of it.

But oftentimes, to your point, those divisions or departments may not have visibility into their specific performance in those areas. So I think number one, data is important, and sharing data. Starting with quality data but also being cognizant of utilization data, especially avoidable utilization because people may not know that their patient, that the next call, and the surgeon gets the call, is it to tell the patient to go to the emergency room or is it to tell them to try to get into their PCP’s office? And sometimes that’s sort of the way in which that orientation is to supporting that care can pivot based on what people understand to be the circumstances and the incentives. I think the incentives are important. I think the data is important. I think a cognizance of value-based care that doesn’t just fall on primary care but includes all different providers, and not just in the hospital and not just in the clinic but links to those in skilled nursing facilities or home-based care or wherever those patients go.

All of that together needs to be an ecosystem of individuals who are formed and educated and know how their contributions participate and contribute to the greater whole of that performance. But academic medical centers have an uphill way to go related to this at large. I think it’s fair to say that some are probably more advanced in this regard than others, but we all have so much learning to do in this space. And I do really think that that becomes an important part of how we continue to move forward transformation and to try to be successful—as you also said, for the good of patients.

Howard Forman: You mentioned Liz Fowler earlier, and I had her here on Monday, or at least by Zoom, on Monday for my graduate class. And she reminded me what we talked about on the podcast probably six months ago or so. And that is, that ACOs, at least on paper, have not performed as well as we wanted them to perform. I shouldn’t say “ACOs.” Really, the projects funded by CMMI [Center for Medicare & Medicaid Innovation] have turned out not to save as much money as we thought they would. They have performed, I mean, there have been some successes, but they’ve been relatively modest compared to what thought 12, 13 years ago. And I’m wondering, you were there at the onset, you’re involved in them right now. Liz did make the point that it may be that some of the benefits that we have within ACOs are actually being absorbed elsewhere. And so we’re actually making savings somewhere else, and they’re just not being accounted for properly. But how optimistic are you? Are you less optimistic than you were 10 years? Where do you see us going and what’s the timeline for this?

Scott Berkowitz: Yeah, I think it’s an excellent question. And as you know, the Innovation Center was established to try to develop new models that could improve quality, reduce costs, and, what you learn from that, potentially to be able to scale. A very direct way in which our office was able to participate that early on, around 2012, was in receiving a nearly $20 million healthcare innovation award for establishing what was the Johns Hopkins Community Health Partnership, where we built a care coordination model in Baltimore. And to be able to work including inpatient, outpatient, other community organizations around care coordination. And it was successful by many different metrics, and it did achieve cost savings, which we’ve shared and published on. But I don’t necessarily assume that every foray that the innovation center would cover would necessarily be able to do so and may have improvements in quality but maybe not in the areas of utilization that they want.

And I think that learning experience and that participation is important. And to be able to get better at it. If you ask me my level of optimism today versus a decade ago, I’m definitely more optimistic because I think we all continue to learn. But let’s not kid ourselves, you all know that this work is not easy, that this work of change management, of trying to wrestle with the issues that Harlan was just asking about, and to be able to do that in real terms within academic centers, when you try to have all of your different missions that you’re trying to succeed on, it may not be top of the agenda. And there’s so many issues that are trying to be addressed, but that’s why it really requires, I think, to ultimately be successful, the highest levels of leadership within care delivery systems working together and acknowledging that those care delivery systems are not just traditional care delivery systems—it’s wherever the patients may go in care.

So I am optimistic, but I don’t have a delusion or a belief that this is easy or it will quickly be addressed. But I do think that the willingness to invest and try and to continue to move forward—and to your point, also around evaluation and analytics—it can be very challenging to measure things around avoidance. And not everyone has the capabilities that a group like Yale may have, or that Hopkins might have, for very robust evaluation analytics and biostatistics. Not everyone has that. So the ability to be able to track and measure and determine how to use those more complicated assessments is another area that I think is important in this investment of efforts.

Harlan Krumholz: On our watch, of course, all we’ve seen is that more and more money being spent in healthcare and less and less return. For you and I, and Howie, we’re very interested in these sort of global population health metrics. And so at the end of the day, what have we really achieved for the health of people in the United States? Now, it’s not just healthcare, of course. It’s all these other forces in society that come together. So it’s not that we can take the blame for it, but it is our watch where we’ve really been unable to translate all of this additional money that’s been spent into real value for Americans. Let’s just talk about the American healthcare system. What’s your hope, let’s just say over the next 10 years, that’s going to really actually turn this around? What do you think might be the major force that will really tip the balance towards actually seeing the United States see major returns for the additional investments that we’re making in health?

Scott Berkowitz: I think that, to the conversation where we started, related to that balance between fee-for-service and value. The more that scale tips towards value, the more that scale tips towards investments such that the services that you’re supporting around value are not just 5% or 10% of all the patients you serve, it’s more like 60% or 70% of the patients you serve. And the penalties and incentives associated with that become increasingly real. It will not only have the agendas and the focus of those who are focused on population health and value and the other areas of transformation, but it will be on every single CFO’s mind, every single CEO’s mind, and everyone else’s mind because it fundamentally relates to, and is integrated within, care delivery. So where I think we will make it, and that’s not tomorrow, and I appreciate that you said a decade from now, is when population health isn’t a standalone, is when my position as a chief population health officer is so ingrained across the delivery system, universally, that it’s not just this is population health over here, this is all population health, that those metrics that you’re talking about, Harlan, they relate to the overall care delivery at large, and not just incremental programs that we try to layer upon. And we’re not there yet. And it requires a fundamental shift in thinking, and the more that the care and the percentage and the preponderance of care is pushed towards value, and there’s money to support that and the investment that is needed, I think it becomes not only more real but something that people can rally behind, because you can’t do this stuff for free. You can’t just fundamentally change the way you’re doing things. So it is going to require that continued building an investment within, and ultimately towards the return that you’re talking about.

But return also, of course, can take different forms. Whether it’s related to quality and cost and utilization or also related to satisfaction and how we define that, how we measure that, and using tools like you and others are developing, I think is really important. But we need to be open to that. But it needs to be a fundamental change in the way that we view value-based care as not as a standalone but as a central component of all care delivery.

Harlan Krumholz: I just want, getting really to the end, I just want to thank you for your time and really for your commitment to focusing on population health. What we really do need, I think, are talented individuals like you to really say, “How do we begin to think of how we’re going to reorganize this system and ultimately judge our success by whether or not the populations around us have done better?” And this has really been emblematic of what you’ve tried to do. I also have great respect, over the years, we’ve talked from time to time about how you’re a great one for investing in your family and making sure that even as you’re a remarkable individual professionally, you kind of really walk the walk on the personal side too. And I think a great role model for many people. So anyway, just thank you so much for joining us today and really appreciate you, Scott.

Scott Berkowitz: Thank you.

Howard Forman: Thanks very much.

Scott Berkowitz: You both have been just outstanding mentors of mine, and I am so grateful for that. And Harlan, you probably don’t know, or maybe even remember, that many years ago, one of the learnings that you shared with me was the importance of coaching. And with respect to coaching, to be the head coach. As you said at that time, this was a long time ago.

Harlan Krumholz: For the kids, yeah.

Scott Berkowitz: Because if you’re the head coach, then you have to show up every time. And I filed that away for years. Now, it’s been years, because my kids are now at such a high level that they’ve outpaced my ability to teach them, related to their sports skills. But I coached them and head-coached them with their soccer teams for years. And I constantly referred to that learning, and it was one of the great decisions I made. And it really did reflect that feedback that you provided, and it was absolutely right. So I hope you don’t mind that I’ve shared that feedback with others as well, and being mindful of the way in which you need to make sure that you’re a full person, and investing in your family and the community and other areas with which you participate, in addition to the work with which you engage professionally.

Harlan Krumholz: Oh, that’s so great. It’s great to hear, and thank you for sharing that. Hey, that was a terrific interview with Scott. I’m glad we got him on. It’s always great to have former students back, and he’s just done so well, it’s great to hear. But let’s get to your segment, Howie. My favorite part of the podcast is to hear what you’ve got to say this week.

Howard Forman: So we could spend lots of episodes, full episodes, just talking about conflicts of interest in healthcare. And we have touched on this in the past, but our colleagues and former students Sanket Dhruva and Joe Ross have just published a brief research note. And I wanted to use their small study to emphasize the challenges to both interpreting and managing these perceived conflicts. And it’s highly related to work that you’re familiar with. So I’m going to be asking your opinion. They looked at publicly reported payments made by the manufacturer of a specific and specialized type of an implantable cardiac device, what we call a left ventricular assist device. Payments made to cardiologists. And they found that, lo and behold, payments, even modest payments, were associated with increased use of the device by the cardiologist. Now, they acknowledge that they cannot prove causality, and they also note that it is possible that cardiologists opportunistically seek out such small payments not as an inducement, but just because they’re already using the device. In other words, “Yeah, I’m using it, so I might as well let them buy me dinner.”

But it does echo findings that we’ve seen with pharmaceuticals, including the study that I was a part of several years ago that showed increased prescribing behavior of certain expensive drugs associated with increased payment to the same physicians. Again, to be clear, now, these authors excluded royalty payments and research payments, so it is about other types of dollars. But these are small inducements—these are dinners and lunches and things like that—and larger ones. But if the connection is causal, it should raise concerns. Particularly in this case, where there’s little to no evidence of benefit from the technology. And you’ll tell us more about what that means. But from what I understand, these don’t even have a marginal benefit over cheaper existing devices.

So here’s my concern. Patients have access to this data. It’s freely available. But they’re rarely informed to know what it really means. And even if they did, would any reasonable person go to a cardiologist and confront them about something like this? And in all fields, including radiology, which is my field, there are numerous opportunities to accept money from manufacturers and other vendors. And in some cases, physicians are receiving funds that come close to, or exceed, their clinical compensation. The incentives to access extra money can be at cross-purposes with the best interests of patients. Hospitals and credentialing and privileging committees try to manage this, but I think they are challenged to figure out what is lucre and what is a reasonable payment for engineering or clinical advice. And so I really am curious, Harlan, because you have thought about this for a long time. What do we make of this study, and what can we do in the future?

Harlan Krumholz: Well, this is a really complicated issue. And by the way, at the American College of Cardiology meetings last week, and in The New England Journal of Medicine, there was a published DanGer Shock trial that, for a subset of people, it seemed actually that these devices are helpful. But it was the first trial that has shown that. And these have proliferated, but without that kind of evidence to date. And they’re being used in a much larger group of people than the narrow group of people, for which this was shown to be beneficial. And the interesting thing about this trial was that there was some benefits shown but also a lot of harm. People went on dialysis, people had major bleeding, some people had catastrophic bleeding, some people died from the complications. It seemed, in this group, that they were able to define that the benefit outweighed the harm, but the harm was substantial.

Imagine going now, if you go out from beyond this group to people who have a lower likelihood of benefit, there could really be a net harm. This needs to be studied. We’re years and years into this, where this was, I think, bought by J&J. Abiomed sold it to J&J for $16 billion. There was a lot of money at play here. You’re bringing up this issue about how much they’re paying the docs to promote this. So this technology was being promoted heavily, especially by some docs who were benefiting financially from that relationship. But the major mechanism of proliferation and benefit that was occurring was, the fees on this device were huge. Hospitals were making a ton of money, physicians were making a ton. Much more than if they would have put in, like the alternative would have been, an intra-aortic balloon pump, an older technology. It wasn’t, for many of these patients, up until recently, known whether one was better than the other, but there was a lot of money at stake.

So this is where I’m torn. People want to make a big deal about how much actually money is being paid, in that way. But in our fee-for-service system, or in the way in which we’re organized, they somehow were able to manage so that there were very big professional fees being paid for the use of this device. And I believe that was the major driver that was really pushing. If this had been nothing with regard to reimbursement or actually a loss, I think you would’ve said to everyone, “Let’s wait and see whether or not this thing is really effective.” But the fact was... I mean, and I’m talking like $20, $30,000. This was major amounts of money being paid.

Howard Forman: But the physician ultimately makes the decision.

Harlan Krumholz: As I understand it, and I can’t tell you the exact number, but it’s not insubstantial. It’s not de minimus. It’s enough that... I’ve heard people talk about it being a meaningful amount of money. So this isn’t a couple hundred dollars.

Howard Forman: Right, more.

Harlan Krumholz: This is a substantial amount. Now, look, I believe in my colleagues. It’s not like they wake up in the morning and say, “I’m going to do this procedure versus that procedure and do it for the money.” But you can’t help to be aware that, you can convince yourself, there are cognitive biases that occur. This is a new technology. You’re kind of convinced this thing works. And by the way, the winds of reimbursement are behind you. It all kind of comes together to help it become adopted in ways where other things that are highly inexpensive and may be higher value, and I’m just talking about throughout medicine, we have trouble getting adopted, because we’re missing that piece.

Howard Forman: So it’s also possible if this study is identifying a confounding variable, which is that these doctors who are making a lot of money off placing these devices are getting these small rewards. And the rewards themselves are not the inducement, it’s the motivation from a commercial insurance company that forces it.

Harlan Krumholz: And they’re also made to be celebrities. They’re teaching other people how to do these things. These things are spreading. What they need to be doing is insisting on more evidence sooner, faster, so that we really know whether or not we’re getting value over these new technologies. Especially ones that can be harmful. And again, I want to just emphasize, I don’t believe it’s that the doctors wake up and say, “I’m going to do this for the money.” I mean, I really don’t.

Howard Forman: I agree with you.

Harlan Krumholz: But I’m just saying, the milieu is created so that all the winds are pushing in the same direction. And what we should be doing is saying, “We need the evidence.” We really need to know if this works before we go out. And in whom does it work.

Howard Forman: I hope we can come back to this again soon, because I do think it’s going to keep coming up, and I want to understand this better because there is a lot of literature that does suggest that industry payments are having an influence.

Harlan Krumholz: Well, I don’t doubt that it leaves people open to information flows and creates, you know,...

Howard Forman: Yeah.

Harlan Krumholz: But I just think that there are other more powerful incentives. And by the way, when these things exist, I think they just need to be managed. I think it’s okay for there to be relationships. Again, assuming that these aren’t just simply buying off people. But in general, there’s no reason that industry and medicine... There can be cross-talk. The question is, they just need to be managed. They need to be exposed, managed, and understood. You’ve been listening to Health & Veritas with Harlan Krumholz and Howie Forman.

Howard Forman: So how did we do? To give us your feedback or to keep the conversation going, email us at health.veritas@yale.edu or follow us on any social media—LinkedIn, Threads, Twitter, what have you.

Harlan Krumholz: And we’d love to hear your feedback; questions, your experiences, what you think we should be covering, how we can do better. You can rate us, review us, on your podcastapp. We always read them, and it helps us to do better, and it helps others to find us.

Howard Forman: And if you have questions about the MBA for Executives program at the Yale School of Management, reach out via email for more information, or check out our website at som.yale.edu/emba. And some exciting news to share, once again with our listeners, on May 30th, we’re going to do a live podcast at the Yale Innovation Summit, live from the School of Management. Links in the show notes today. Come to the Innovation Summit and see us interview some of the greatest health and technology innovators.

Harlan Krumholz: I can’t wait to hear what you’re going to do live, Howie. It’ll be good. Health & Veritas is produced at the Yale School of Management and the Yale School of Public Health. Thanks to our researchers, Ines Gilles and Sophia Stumpf, terrific Yale undergrads who are just amazing. And to our producer, Miranda Shafer, who somehow makes us sound good every week. I don’t know how she does it.

Howard Forman: Thank God for all of them.

Harlan Krumholz: Talk to you soon, Howie.

Howard Forman: Thanks very much, Harlan. Talk to you soon.