Howie and Harlan talk with Gil Addo, CEO and co-founder of RubiconMD, which is aiming to expand access to specialty care by providing virtual consultations to primary care physicians. A new study from Harlan examines a loophole that is allowing unreliable medical devices to enter the market; Howie provides an update on legislature that will soon cause millions to lose Medicaid coverage.
Harlan Krumholz: Welcome to Health & Veritas. I’m Harlan Krumholz.
Howard Forman: And I’m Howie Forman. We are physicians and professors at Yale University. We’re trying to get closer to the truth about health and healthcare. This week, we’ll be speaking with Gil Addo, a Yale alum, about his startup, RubiconMD. But first, I usually ask what’s got your attention, Harlan, and you had a paper come out this past week in JAMA, leading medical journal, about medical device recalls. Can you tell me a little bit about that?
Harlan Krumholz: Yeah, I was working with Joe Ross and Sanket Dhruva, who was a former fellow here in... and actually, a Harvard medical student who actually led it, Kushal Kadakia. And what we were looking at were medical device recalls. So many, many devices are authorized by the FDA each year through a special pathway. It’s called the 510(k) pathway. And basically, it says if you have a new device and it’s substantially equivalent to an old device, then you don’t have to collect any more information from patients. You don’t have to do any studies if it’s pretty similar. And that’s because lots of people want to introduce new devices that have just minor tweaks from old devices. And the FDA and the law sensibly says, “Look, if you’re just tweaking it slightly, you don’t have to go through all the effort of trying to study it in lots of patients.”
But what we discovered was that there’s a loophole in the law. The law says that if the FDA withdraws a device, particularly with a Class I recall, that means that they’ve recalled it because it’s a life-threatening harm it could cause to people. It’s a big deal. And if the FDA pulls something off because of that, then that device can’t be used as a basis for a new device. So someone can’t put in a new device and say, “Because it’s substantially equivalent to that device—that device that was recalled—it should be authorized for sale.” Of course, that doesn’t make any sense. That device was considered unsafe. It was pulled off the market. So the law sensibly says, “But the loophole is, if the manufacturer voluntarily, voluntarily recalls,” not the FDA but the manufacturer jumps in and says, “Okay, we’re going to pull this off the market,” or, “We’re going to recall this with a Class I recall before the FDA does,” then that device, in fact, can be used as a basis for future devices.
So we found a situation, many situations, where devices, in some cases, implantable devices, very high-risk devices, that had been pulled off the market were being used as a basis for a new device. New device was being introduced and said, “We should be able to get a pass-through because we’re substantially equivalent to that other device.” By the way, that other device that was recalled. And the FDA was hamstrung because the law had this loophole. And then those devices tended to be used in tens of thousands—many, many people. And then, at a high rate, were often then recalled subsequently. Well, it doesn’t surprise you, that device was authorized based on a recall device, and that device, ultimately, was recalled. By the way, we also found that that device was then being used as a basis for future devices. So there was a whole family lineage of unsafe devices that were continuing to be put on the market, and the law was constrained.
Now this isn’t an error or problem with the FDA. It’s a problem with law, and Congress has to step in and fix it. Ed Markey had introduced something when he was in the House of Representatives about this. We hope that this article will stimulate efforts to try to help make medical devices safer. And though, in the big picture, I want to just tell people listening: most devices aren’t recalled. In fact, some of that may be because our surveillance systems aren’t good enough to detect problems, but largely, I don’t want to worry people about devices. But there are some very important devices that are approved based on unsafe devices, and we’re trying to call for that to stop.
Howard Forman: And just for our listeners, how is that different than the drug development? Are drugs recalled in the same way? Do drugs have the same problem?
Harlan Krumholz: So it’s a very, very different process. I mean, this was put into place. There’s a pathway for new devices that are high-risk, that the FDA feels needs to have clinical information about it just like drugs. But there’s this pathway where if you’re similar to another device, you don’t have to provide any clinical information. And in general, you have to provide a lot more information about drugs. The device pathways are so different. The levels of evidence, the thresholds of expectation about creating studies are just so much higher on the drug side. And yet, these devices, they can produce a lot of benefit. They can cause a lot of harm. And a lot of us are suggesting that what we need to do is to be very thoughtful about trying to not stymie innovation but at the same time promote the idea of safety. By the way, there was another paper by Alex Everhart at Harvard that was in the same issue that was also echoing and reinforcing a lot of the same points about these “flawed predicates,” they call them.
Howard Forman: Yeah. It’s really important that we continue to illuminate these issues because I think there’s a balance that needs to be struck about the speed in which technology reaches patients but also the safety that we ensure that allows these products to be safely and effectively used. And there are a lot, we could go through a long example of implantable devices, whether hip replacements or screws for spine surgery or pacemakers or valves that have been recalled, that have had major consequences for patients. And anything we can do to minimize that while still encouraging innovation would be great.
Harlan Krumholz: Yeah. There’s another facet to this work, by the way, Howie, which is that some people have told us that you should be very careful about criticizing the FDA. This is, again, not a criticism to FDA but of the law but could be perceived as an FDA criticism. Because the FDA right now is in a very tenuous position. It’s being attacked from all different sides. And some people, even officials are suggesting that academics need to step down from a lot of their scrutiny of regulatory science. I think we take a little bit different view which is, one, we recognize that the FDA’s full of really committed professionals doing the best job they can.
I posted that on Twitter. Actually, lots of people attacked me about that. Look, that is just true. And a lot of this research is intended to identify opportunities to improving strength in the FDA. And the fact that any articles would be weaponized against the FDA is unfortunate. We can’t control it, but we have to continue to stand up strong and say, “We’re not publishing these things to hurt our national institutions but rather to help make them better. And we want to work hand in hand to do that.”
Howard Forman: Yeah, good science should never be criticized. We should learn from it and build off of it. But to criticize it is real—
Harlan Krumholz: Yeah, we’re just in this era of weaponization of whatever you do, and of course, any COVID studies immediately taken on by either side. Great. Howie, look, we’ve got a great person coming today. I’m so excited. A former student of yours. Let’s move to the interview segment.
Howard Forman: Gil Addo is the CEO and co-founder of RubiconMD. This eConsult platform allows primary care physicians to consult with specialists online, allowing quicker and increased access to complex healthcare. And we will let him tell us in greater detail why this is so important. He co-founded RubiconMD in 2013. Today, it serves over 8,000 primary care clinicians, the Huffington Post named RubiconMD one of the five companies defining the future of healthcare. And in 2020, AllianceBernstein ranked RubiconMD number 12 on its list of the top 25 private companies disrupting healthcare. He’s been named in Forbes magazine’s 30 under 30 in healthcare, Crain’s New York Business’s 40 under 40, and Business Insider’s 30 under 40 in healthcare. He received his bachelor’s from Yale in economics and biomedical engineering, which is when I had the great fortune to meet him 17 years ago when he took my class, and then went on to get his MBA from Harvard University.
And I want to start off because you... I appreciate it very much. You came and spoke to my class just a few weeks ago. And one of the images that etched in my mind is seeing a young Gil Addo, maybe you’re 12, 13, 14, standing beside your grandmother in a bed and I think in Barbados. But it was centered on her healthcare during a very, very difficult time in her life and your family’s life. And I think that played a big role in how you’ve built RubiconMD. So I thought, just tell us a little bit about how that moment in time has led to where you are now.
Gil Addo: Yeah. Well, first of all, thank you guys for having me. It’s fun to be invited to these types of things and to be able to share with you guys some of the work we’re doing. So I’m honored and excited to have this opportunity. A lot of my career has been directed by that experience. So just to give the context behind the photo. My grandmother on my mother’s side, my family from mother’s side is from Barbados. My grandmother was there, and she developed a brain tumor. She traveled to Boston to one of the major academic medical centers there and had surgery, incredible teaching hospital that everybody would be familiar with. And then spent five years going back and forth between Barbados and Boston on the management of the tumor, all the post-op management. That’s five years going through my childhood.
That’s a pretty impactful experience to have her coming, leaving, family coming together. I know folks have all had loved ones go sick, and that stuff brings people together. And at a young age, it can have quite an impact. So the thing that I took from that early on was I wanted to be in healthcare. I wanted to do something that had real impact, and I wanted to impact the system. I didn’t know what that meant. It wasn’t until I got further along, probably I give people the commercial for your class, Howie. That really exposed me to healthcare at a system level. What are all the forces that impact the delivery of healthcare? And it really helped me to understand that what was really happening with my grandmother was an access challenge. And there’s fundamentally just better access in these centers that have been co-located geographically for very good reasons in the past.
And so I wanted to build something that took that expertise and got it out to the communities where is necessary and valuable. So I met my co-founder, Carlos, in 2013, and we started building, and we built RubiconMD, really, on this mission to democratize medical expertise. And that’s at the DNA of everything we do, is that mission. People join us because they’re mission-driven, and we try to keep that front and center. And I will say since starting the business, probably once a year, there’s an experience I hear about or somebody tells me about with their loved ones, or recently my wife’s gone through with one of her close friends that reinforces that need for access and all the challenges that emerge from not having it.
Howard Forman: I want our listeners to understand how transformative RubiconMD can be, and I think it is, but I just want you to explain it more because... so I’ve had a complicated medical history, and each time I’ve recovered from surgeries, I’ve had multiple specialists that have had to be scheduled. I’ve had a primary care doctor who thankfully is willing to coordinate care, but the time that goes into it is enormous. And you’re taking somebody who’s in an infirm situation and asking them to do what you just described, go out, make appointments, physically get somewhere, and so on. Talk us through how RubiconMD can simultaneously empower the primary care doctor and also give better care delivery to the patient.
Gil Addo: Yeah. So the way it works is the patient will go see primary care, which we believe is the foundation of the healthcare system, and the group that should be quarterbacking care for patients. They’ll go to see their primary care provider. The primary care provider, if there’s something that is outside of their expertise or where they don’t feel fully comfortable managing the patient, typically that would’ve been a referral, which would’ve triggered a number of processes, all the things that we know. 40% of the time people will actually make it to the specialist. By the time they get there, they may know what the issue is, they’ll have to redescribe it, the records may get there. And even in the best-case scenario where it’s a system that’s fully integrated, that person will then see you in person and then they will follow up. That could be weeks, it could be months. It all depends on the specialty and the access within geography.
So what we’ve enabled is a network of specialists, and they provide their expertise to primary care providers in a couple hours. And it covers 140 specialties and subspecialties. And they provide... our core is what we call eConsults, which are text-based opinions where they’ll look at the question from primary care, review information, potentially labs, X-rays, other images, and they’ll provide an opinion back. And what we found is that about half the time, the patient doesn’t need to go see the specialist. And that what we’ve started to build out now is a broader set of virtual specialty care services. We were recently acquired by a company called Oak Street Health. And part of the vision there was to move closer to patients and primary care to be able to provide more ongoing support and to be able to help collaborate directly with primary care in a more intentional way. And so that’s what we’ve been releasing, and the vision is that you can essentially make every primary care practice in the country a multi-specialty practice where the specialty is all virtual first.
Harlan Krumholz: Gil, I wanted to first express appreciation for you coming on and really admire what you’ve accomplished. And it’s just really remarkable. You know, come out of school, you do a few rotations with a few different groups, but then you come out and have the courage to try to build something entirely new. It’s both hard and remarkable. It’s amazing. And you’ve built something that looks like it’s going to be enduring. I had a question for you about something that you said that I thought was interesting and important in an interview that you did. You said many people may think about RubiconMD as a technology innovation, but we’re actually a business model innovation. We’ve figured out how to enable access to specialist expertise without necessarily going through traditional fee-for-service payment mechanisms. And you said the fundamental thing here is that companies that are really innovating are not necessarily building really novel technology but are figuring out ways to actually make it work and implement.
I thought this was really interesting because people tend to be attracted to the bright shiny objects of technology, which can be amazing. But by and large, what we really have is a gap between the technology that could already enable us to do things in figuring out sustainable business models and way to actually drive value both for people who might invest, but even more importantly, for the people who might benefit. And it does seem to me, in this case, that you were really trying to bridge that. I wonder if you could just talk about that a little bit. How did that come to you that, really, that Rubicon was... Yeah, I mean, had to have a strong tech stack, but the real innovation here would be bridging the business model.
Gil Addo: Yeah. So I’ll say two things about it. First is that all of the stuff that people think about as pushing the envelope and things that we’ve seen through COVID around health tech innovation is taking technologies that we use in all parts of our lives and don’t even think about. Telehealth, virtual care, all these things that got accelerated through COVID and are at the forefront of innovation. There are companies who’ve become huge innovators just by enabling texting with patients and providers who just allow you to make a phone call or do video visits. I could FaceTime my mom, that shouldn’t be considered incredibly innovative. The challenge is that the healthcare system is really not set up to enable those types of incentives for people to do that, right? I had to miss going in person to Howie’s class a few weeks ago because my daughter got sick.
To get her back to school, basically, you’ve got to get a doctor’s note, for good reason. I understand all the forces at play and the reason why they need it documented. But to do that, the only way the pediatrician is set up is that you have to go in person, which is in person into the city, figure out parking, basically take a half-day off just to get a note that says she’s fine. But there’s a tech service, a very cool service. It is called Summer Health, like give them a little bit of press. But they basically allow you to just have a chat with an incredible doctor or they’re trained at top-tier institutions. And that tech service will allow that person to basically just find out whether or not you do need to go in person, and they don’t have an incentive to bring you in person. So those types of things are just taking existing innovations that otherwise wouldn’t exist in healthcare because the incentives are to go in person.
Harlan Krumholz: Critical to this model is the idea that there’s not an incentive for the specialist to see more people, because in our fee-for-service system, I want to keep my waiting rooms full. I want to keep the lines for the echocardiograms and the stress tests and all these things going, because the business model’s built on volume and that has to be continued. One of the things that you’ve done here is you’ve created a great service for a value-based system, one in which you’re actually getting rewarded. The healthier patients are, the more efficiently you can deliver care, the better service you can provide.
Unfortunately, in the vast swaths of America, that’s still not here. And we’ve been talking for 20, 30, 40, Howie can tell us, many, many years about the value-based horizon. When is it going to come into view? What’s your idea about this and how were you able to overcome the fact that there’s still a lot of fee-for-service in America? So how are you able to get people to want to use the service for specialists to essentially maybe to be decreasing their volume by using it? And where do you see about the future value-based care?
Gil Addo: Yeah, this is a great question. So for us as a business, we had to do what most businesses do. We had to have a foot in both canoes, the fee-for-service and the value-based. And I wish we had just taken a stand earlier and said value-based care is the way where the world is going, and that’s how we will operate. But that wasn’t the environment that we were building a business in. We’re a venture-backed business. We have to continue to grow. So we support a model where the health plan pays for RubiconMD, and we support a model where the value-based provider organization pays for RubiconMD. And so it’s whoever is at risk for specialty care. In both settings, the service is offered the same way. Primary care asks the question or gets input, and specialists provide their response.
The big difference is that in the payer world, we have to go out and sell the providers as a secondary sale, essentially. And so that’s basically what the tension. Incentives are more aligned. It works better. It’s easier to roll out. Everything works better in a value-based setting, but there’s clear need. And our vision was always to be able to provide this, and support, and have the impact. And so you still have to do things in a fee-for-service world. So we still have that offering. I think the reality is we haven’t reached that tipping point where things just work in value-based, but we are seeing more companies get to scale. I think what selflessly Oak Street Health has done, what Iora Health has done. Well, a lot of the alums of your classes, Howie, I sit in rooms with them and they: “Oh, you get to go back?” And: “No, I’m...” So I think a lot of the people who are being trained to see the world from that lens are now leading organizations that are getting to scale. And I think the more organizations you get to scale, I think you start to build the ecosystem where the services can be tailored to them, and then you see the outcomes, and it continues to mushroom. So I’m optimistic. We’ve been doing it for 10 years, and that question was as relevant 10 years ago as it is now. But there’s still been a lot of progress, and there are a lot of more examples now where there’s truly an ecosystem of organizations that are executing in that way.
Howard Forman: So this is a quick unfair question, but I’m going to do it anyway. And that is, we have a huge health system here. We have this enormous multi-specialty group here. What stops Yale and Yale New Haven Hospital from building their own Rubicon model internally? What is special about your model that we couldn’t build on our own?
Gil Addo: Nothing other than Yale doesn’t have the same incentive to do it. And people always went like, “Why do small companies end up surviving when big incumbents can do this?” We’ve had probably a couple dozen organizations that have said no to RubiconMD because they were going to do it themselves, and almost to a one, they’ve all come back to us to implement. Not everyone, but even the ones that haven’t come back to us, they still haven’t been able to do it successfully because the challenges, you have to go to every single department and you have to go through department head and then, organizationally, and then you have to set up the schedule. You have to build all the operations. You’ve got to be very good at technology. We’re a tech company at our core. And then you’ve got to be able to run the service when people don’t have the incentives.
It’s so much easier to rebuild the network from people who were really great, trained clinicians who wanted to do this. We even went to a lot of those departments and realized that it was way more time than just going to the specialists you needed. Because we’re paying, again, we’ve aligned the incentives in such a way that we’re able to get them to provide their input very quickly. They’re the busiest, like, department heads can never get on their schedule to say this in one minute. I went to visit a group in Washington, the head of the department couldn’t get time with him. One of the top clinicians in the country, very hard to get. He has maybe the fastest response time on RubiconMD. You send him something, he looks at it, responds quickly, because we figured out some of the things around how to make this very quick. And there’s a lot of UI things that you have to do for them. So I think you could. It’s just the incentives don’t work the same way.
Harlan Krumholz: Here’s one final question for you. Gosh, you’ve been immensely successful. You stepped out into the role of founder and CEO from the very beginning. Can you just tell us a story about what was the hardest day and how you overcame it? Was there a day when you—
Gil Addo: That’s a great question.
Harlan Krumholz: ... thought this isn’t going to work, and you were able to work past that? Can you tell us something about that?
Gil Addo: Yeah, of course. There’s plenty of days like that. I think entrepreneurship, it also takes a very personal toll on you from a life perspective. My then girlfriend, now wife, was living in New York, and I was in Boston, and was coming back, and I decided to start the business with Carlos in New York. And New York’s really expensive, and wanted to focus on it and thought I had about a year of rent. And turned out I had maybe five months, and I went out to try to buy an engagement ring, and the stress involved in that process was worse than any fundraise. I wasn’t sure we were going to be able to get to close the money, to be able to get the ring, to also be able... That money wasn’t for the rings, excuse me.
Harlan Krumholz: Right. Yeah, sure.
Gil Addo: But also to be able to continue to fund the business. So I think people forget that. You’re also building the business in the context of a life, and a lot of those things end up being real considerations why people either have to step back or can’t do it. And I think that’s the more real thing.
Harlan Krumholz: No, really appreciate you sharing that.
Howard Forman: In 10 years, you’ve accomplished an awful lot, and I expect we’re going to keep seeing a lot coming from you. So I just want to thank you so much for coming back and talking to us, and hopefully we’ll get you to come back again soon.
Gil Addo: Thank you guys for having me. It’s very much appreciated.
Harlan Krumholz: Wow, Howie. That was really a terrific segment. It’s so great that we had Gil on here. Let’s go to this segment about you and your views, but I have a question for you, though, before you get into anything, which is, we talked a little bit on the other podcast about the end of the public health emergency and what that might mean for Medicaid, and the people in the expansion of Medicaid, and people were covered by that. So we were talking about that, expecting that that might happen, but then, President Biden extended it for another 90 days just last week. Are the Medicaid beneficiaries now safe? How do you think about this now?
Howard Forman: Yeah, so it turns out right after we had that segment, we said they might end the public health emergency. Biden decided to renew it for another 90 days. But it also turns out, unbeknownst to me, that on December 29th, when Biden signed into law the most recent appropriations act, which is called the Consolidated Appropriations Act 2023, when he signed that into law there were two big changes in there that very much affect this whole issue. It decoupled the Medicaid enrollment issue from the public health emergency, and that means that starting on April 1st, Medicare beneficiaries will no longer be re-enrolled in Medicaid without question. You will have to actively continue to demonstrate that you qualify for Medicaid, and that means a lot of people will fall off the rolls. The estimates range between, basically, 5 and 15 million people. And many of those individuals who will fall off the rolls will still qualify for Medicaid.
They just have not submitted the documentation that would allow them to continue to be enrolled, which means that we’re going to have an increase in the number of people who are uninsured in this country, and it will be unnecessary. And then at the same time, beginning April 1st and ending at the end of the year, the extra money that the federal government has been using to subsidize Medicaid programs in the States will also phase out. And those things are going to have a very significant effect in both Medicaid enrollment in terms of the services that are covered and in terms of the fiscal strength of our state. And I think we’re going to see ramifications flow from that over the course of this year.
Harlan Krumholz: What happens to those people who lose Medicaid during this period? Are they just out of luck? I mean, what—
Howard Forman: Yeah. So, Medicaid is extremely dynamic, and I think people don’t fully appreciate that. When we say that there’s 83 million people on Medicaid, it’s not that people are on Medicaid from the day they’re born to the day that they die. Very often, people are on Medicaid in between a job. They’re on Medicaid as they’re growing up in an impoverished household, and when they go off to college or to take their first job, they’re insured by their employer. So, Medicaid’s very dynamic. I mean, much more than people give it credit for.
When people are thrown off the Medicaid rolls, they are uninsured, and maybe they’re going to be uninsured for three months because that’s between the time that they finish high school and begin college, where they may have access to insurance there or where they start a job. Many of those people are uninsured until they get admitted to the hospital for a catastrophic condition, and the hospital helps facilitate their reapplication for Medicaid, and then they get plugged back into the system. But we have really strong evidence over the decades showing that the lack of insurance has health consequences for individuals. So, saying that somebody can get back on the rolls of Medicaid is not the same thing as saying someone has Medicaid and is getting regular primary care on a schedule.
Harlan Krumholz: I wondered, Howie, if you saw this thing out of Gallup. It was reported by The Washington Post just this week, that still and all, even with this Medicaid expansion, even with a dropping of uninsured in this country, that 38% of Americans—38% of Americans—reported that they have not sought medical care because of costs, that they’ve either delayed or just given up on seeking medical care for themselves in certain circumstances because of costs. What are your thoughts about that? This just seems unacceptable in this country, and yet this is our norm right now.
Howard Forman: It is our norm. We’ve talked about this. You’ve written about financial toxicity. There are real impediments to getting usual care, and we’ve not tackled it in an effective way. The nice thing about Medicaid, by the way, is that physicians and hospitals are restricted to nominal coinsurance. So there are no financial obstacles to getting care if you’re in the Medicaid program. There are access obstacles when you’re in the Medicaid program. Not every doctor takes Medicaid. So we’ve just got a broken system, Harlan. You and I have talked about this before. Over the last several decades of teaching this right now, I’ve gone from being far more having faith that somehow our capitalist free market system is going to resolve these issues to a point where right now, I believe, that anything short of us having some type of single-payer system will always have the problems that we’re talking about.
Harlan Krumholz: Yeah, it’s truly not just about saying people are insured, but it’s about whether they’ve got adequate insurance and what kind of burdens it’s imposing upon.
Howard Forman: Exactly.
Harlan Krumholz: Yeah. More to come, but we’ve got to solve this as a country. 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 keep the conversation going, you can find us on Twitter.
Harlan Krumholz: At H-M-K-Y-A-L-E. That’s @hmkyale.
Howard Forman: And I’m @thehowie. That’s at T-H-E-H-O-W-I-E. You can also email us at email@example.com. Aside from Twitter and our podcast, I’m fortunate to be the faculty director of the healthcare track and founder of the MBA for Executives program at the Yale School of Management. Feel free to reach out via email for more information on our innovative programs, or you can check out our website at som.yale.edu/emba.
Harlan Krumholz: Health & Veritas is produced with the Yale School of Management. Thanks to our researcher, Jenny Tan, and to our producer, Miranda Shafer. They are amazing. Talk to you soon, Howie.
Howard Forman: Thanks very much, Harlan. Talk to you soon.