April 29, 2021
Gary Bisbee 0:06
Healthcare leadership is hard work, but what if you could learn from the most brilliant and influential minds in healthcare and beyond? What would you ask them? Would you ask about politics, policy, or maybe leadership? On the Gary Bisbee show, I’ll do just that. You’ll hear from healthcare’s most successful leaders and those experts who they listen to, as together we’ll explore how the health economy is transforming. Dr. Don Rucker was a uniquely qualified director of the Office of National Coordinator, known as ONC. He trained and practiced at the intersection of medicine and information technology over the last 30 years. We held our conversation in February 2021, shortly after he left office and went on a well deserved skiing holiday. As Herbert Hoover promised, “A chicken for every pot” in the 1928 presidential campaign, the HITECH Act of 2009 financed an EHR in every hospital and most doctors’ offices. The $35 billion spent from 2010 to 2020 went a long way toward digitizing medicine and creating the need for standards and regulations addressed by ONC. What did Don speak about during our free flowing conversation? Let’s start with patient’s control of their health information, interoperability, transparency, information blocking, and data exchange between providers and insurers. As Don said, “Where consumers have control of their information, interoperability is a given – think banking and airlines. In healthcare, we have to fight for that. And we did.” All in all, I give Dr. Don Rucker high marks for accomplishments during his 4 years in office and his commitment to a bipartisan approach. He deserved his skiing vacation. Don holds a BA from Harvard, an MD from the University of Pennsylvania, and an MBA and MA from Stanford. Good afternoon, Don, and welcome.
Don Rucker 2:17
Thank you, Gary. Always a pleasure.
Gary Bisbee 2:19
Why don’t we start at the beginning, briefly get a little feel, Don, for you. What was life like growing up?
Don Rucker 2:26
Grew up in a family in New Jersey with immigrant parents, so that sort of always colors the experience. Father was from Germany, mother was from Estonia. I guess today that doesn’t count as multicultural, but for New Jersey in the 60’s, it certainly was. My dad was a physicist and so we sort of came from a science/math kind of background assumption.
Gary Bisbee 2:53
Where did your interest in medicine come from, Don?
Don Rucker 2:56
Well, first, I wanted to be a pilot, then I got glasses and my mother was pleased that I got glasses so I couldn’t be a pilot. That was the first plan and she said, “Okay, you can’t be a pilot.” I don’t think that’s actually true, but what did I know. And then, when I was an undergraduate trying to figure out how to push whatever I could understand in science, I actually met the requirements to major in both chemistry and physics as an undergrad. So you can imagine a lot of very math oriented types of things. I had to be realistic, I knew I wasn’t going to be smart enough to be a world class physicist or chemist, but I thought that the medical stuff I could do. And so that was sort of natural. I actually toyed with the idea, which was very unpopular in the 70’s, of going into business, going to business school and doing something there. Family background, had no business sense discussion ever, never came up at the dinner table kind of thing. But at any rate, I went to med school. And then honestly, within a year, I pretty much realized that American medicine was a very problematic activity – both from a business, right, sort of an allocation of goods, I had an interest in public policy even in college and did a lot of reading in economics and things. So both from an economic and, frankly, from a patient/customer service/performance of care type of view. And at that point, Penn, as you may remember, was a wonderful place to explore the intersection of healthcare, economics, policy. And at that point, I was sort of full bore trying to figure out, I thought, well, do I just get out of this thing? And I said, there’s probably way more things to impact here than any other sector of the economy. So let me use the medicine as background to do that. And then really went into exploring what could be done or what I could add.
Gary Bisbee 4:56
And where did the interest in information technology and informatics come from?
Don Rucker 5:00
So that was a little bit of a circuitous route to be truthful. When I went to college, right before college, my dad, who as I mentioned was a physicist, told me there were two things he didn’t want me to do. And I’m thinking – sex, drugs, and rock and roll is three things, so out of that…
Gary Bisbee 5:19
Which are you going to give up, right?
Don Rucker 5:21
What are the two things? And he said he didn’t want me to do anything in computer programming or statistics. Which was like a total, “What?” since my dad comes from programming and was a physicist. And his advice, which, you know, maybe I’m rebelling against for the rest of my life, though we have a very good relationship. He said, “Computer programming you learn when you need it.” I think that’s true of programming, I don’t think that’s true of computer science, which you really need to understand data. But again, different opinions, different era. And statistics, he sort of made the point that has a certain truth to it, which is, if you need to show statistics for something, it’s probably not true. Now, my dad designed explosives for a career so he had a pretty high standard for what worked. There’s not a lot of tolerance for failure in explosives. So where he was coming from, those were good. So I didn’t do any computer classes. There was only really one computer class, really, or two back when I started Harvard in ’73. Now that didn’t bother two of my college classmates, one of whom I knew a little bit, Steve Ballmer and Bill Gates, who found plenty of stuff to do in computing, but I didn’t get there. Actually, you know, I would have loved to have met Gates, never did. But when I got to med school, I thought, I was very heavily influenced by John Eisenberg, whom some of your audience may know. John was eventually the head of what’s now AHRQ; did many, many things in healthcare policy; was an absolutely charismatic person; and my third year in med school was his first year as a faculty member. And he’d had sort of a spectacular rise combining MBA and residency and he was very charismatic. And there were a couple of us that he got hooked on decision trees and decision analysis. So I pursued that with John, did a custom rotation with him, did a research project with him, we never had enough data to actually get anything published, but worked directly with John because I was just so fascinated by it. And after med school and residency at UCSD was thinking, you know, I’m going to do something around that. Residency was sort of a wake up call for me. And as with probably many docs, maybe all docs, and I realized as I was going through residency, the issue was not want of decision trees. Wish that it were. The issue was basically, there was no data to even do a decision tree. So now we’re talking early 80’s. And at that point, you sort of figure out, okay, I’ve sort of wanted to change things. Clearly, so ’81 the Apple II had been out, the PC had come out, the Mac was still a couple years, it was ’84. And it was clear that having a computerization approach to this is what was going to be needed. That was abundantly clear. When you’re in your late 20’s, finishing residency, and trying to figure out how the hell am I going to learn computer science, that part wasn’t clear. A lot of sunk costs seemingly at that point in one’s career. So that part wasn’t really at all clear to me. And the tail end of residency was basically, besides being a resident, was trying to figure that out. I was just, honestly, lucky as hell. I wrote letters to people on a typewriter mind you, this was before word processing, really, on a typewriter describing what I wanted to do. And just through absolute fortuitousness, Hal Sox was, at the time, the head of general medicine at Stanford, said, “Oh, there’s this young faculty member across the hall named Ted Shortliffe who’s starting a program in medical computing. You ought to write to him.” So get the typewriter out again, “Dear Professor Shortliffe,” or I think it was assistant professor back in the day, “interested in this?” So I was lucky enough to get into that with the proviso that since I’d never taken a computer class and it’s a little bit hard to do computer science as a grad student without any undergrad that amongst other things, which I was very pleased to do, that I would do the entire undergraduate Stanford CS curriculum, which I did, other than compilers. That was the hardest academic stuff I’ve ever done, probably, maybe some physics things. And then was also interested in the business school stuff and was lucky enough to get into the Stanford MBA program. So, yeah, that’s how I decided to approach the businesses of data and healthcare. Those were the tools that I decided to try to arm myself with.
Gary Bisbee 10:09
Well, it’s a fascinating background and the fact that you came to data, really, as the core of it speaks a lot for your ability to cut through a lot of what’s going on today and get to the main point. Why don’t we fast forward through your time at Siemens and get right to ONC. For our listeners or viewers who may not be familiar, could you describe the Office of National Coordinator for us, Don, please?
Don Rucker 10:37
Sure, Gary. The Office of National Coordinator is what in gov speak, which you become sort of a bit of an expert at, trying to use as few neurons and that as possible, but is a staff agency, so one of the smaller agencies within the Department of Health and Human Services. So technically, we, you know, you report to the cabinet secretary Alex Azar, in my case. The operating agencies and HHS are the ones that are household words – CMS, NIH, CDC, smaller one AHRQ, FDA. And was started by President Bush in 2004 really to encourage medical records. So David Brailer was the first national coordinator, has sort of probably the longest title outside of anything in the Defense Department – National Coordinator for Health Information Technology in the Office of the National Coordinator for Health Information Technology. Everybody sort of shortened it to ONC for sanity’s sake. And again, pronounced “O-N-C” as opposed to “onc,” I was told the first day I got there. So it’s the agency that is involved in the certification of electronic health records through the HITECH Act. And then CMS payment, things tied to use of certified electronic health records. It’s also, more broadly as you could imagine from the title, here to the encouragement of the infrastructure in health information technology. So a lot of work focusing on supporting standards organization, convening around standards, getting by and around standards, doing that nationally, internationally. So I think if you look at the core things, obviously, we had a huge regulatory role as well with the Cures Act. But if you look at the core ongoing activities, they’re the encouragement of information technology through modern data standards, in many ways, large and small. And then the certification of our electronic health records to encourage/quasi mandate/mandate, the use of those standards.
Gary Bisbee 12:42
As director, you always wonder from the outside looking in what degrees of freedom you have to set strategy, change direction, and whatnot. How would you define the role of director, Don?
Don Rucker 12:56
Yeah, that was an open question to me. You know, when I got there. I mean, you hit it spot on. Which I obviously had a bunch of ideas on what I think needed to be done next around standards and interoperability. And that’s a complicated thing because it’s as much a volitional thing around incentives as opposed to just bits and bytes and technical standards. So I had, obviously, having spent 30 years in the field, a pretty good idea of things that could be done or should be done. I did not, truth be told, appreciate the impact of the 21st Century Cures Act, had a big Title IV and that was entirely on mandating interoperability. I thought I was going to have to do this with, sort of a much thinner set of, if you will, authorities. I had, like most folks in this space, thought of the Cures Act as an FDA reform document and the data around clinical trials and FDA decision making. That’s 90% or 95% of the text in the Act. I did not realize that in that, again, this was just passed shortly before I got there. It was passed almost unanimously, December 2016. So that was not known to me that not only were there interoperability provisions in there, but with a great kudos no doubt to the technical assistance provided by my predecessors, Karen DeSalvo and Vindell Washington in the Obama administration working with Congress on both sides, that the language was extraordinarily empowering. And really said, there shall be standardized API’s. It was framed as API’s – Application Programming Interfaces – without special effort and there shall not be information blocking. Those are extraordinarily powerful mandates to do the right thing in interoperability. So at that point, it was just the huge work to take what were a couple sentences, clear directives from Congress, bipartisan, but take those sentences, it was actually about 40 pages when you get through all the things, and make that into something that made sense for the country.
Gary Bisbee 15:20
Well what kind of progress were you able to make then?
Don Rucker 15:23
Well, maybe I’m not the right judge of that. But in my view, huge. We put out a interoperability role. And so that includes a lot of things administratively, right? So because all of these federal rules are done under notice of public comment rulemaking, NPRM. So with vast dialogue from stakeholders, I had easily 200 meetings with stakeholders. I met with everybody who wanted to meet. My policy was an open door policy at ONC. And lots of public speaking, I don’t know exactly the count. But, you know, I think it’s something 100, 200, 150 outside speaking events. I think maybe even 1 or 2 on your turf. And you have to really build a consensus, educate, get people pumped about the stuff. We did all of that. I think we have put in the absolute best on some of the critical lifts within the legal framework we have in the United States in terms of protecting privacy, security. One of the things that’s maybe not as obvious to your audience, “there shall not be information blocking,” which requires a lot more definition, right? What is information blocking? And ONC was involved in the “exceptions to information blocking” as a practical matter since vendors could say and have said in the past, “We’re just not going to share it,” right? Just period. And then you have the delicate balancing act solving what in physics is an unsolved problem, which is the three body problem. And so, right, the three bodies are two bodies covered by the information blocking provisions, who are EMR vendors and providers and then patients. So just the economics of it to play out and to solve, and in rulemaking solve is a big word. But you know, to address the rulemaking, patients should get their data for free. This is just part of the practice of modern medicine. The federal government, state governments regulate the provision of medical care all the time in 1000s of ways large and small. And patients should just have their data. This is sort of literally a human right, I believe, to have your data. That’s fine. But it’s, “free.” Now, of course, it’s not free because you pay for the care. It’s embedded in the cost of care. But at the margin, it’s, “free.” And obviously the vendors on their side need to have return on investment, they need to have incentives to invest, they need to have incentives to innovate, which leaves the providers who typically have bought EHRs that they can’t just switch out because of the switching costs at the mercy, if you will, of their EHR vendor, their incumbent vendors on the one hand and then having to provide something new on the other. And so we came up with sort of provisions on costs reasonably allowed, that really, I think are very pro public in giving vendors reasonable returns, obviously there are all kinds of issues on how you define that and think about that just from a philosophic point of view, frankly, as much as anything else. But yet, protect providers so that they can operationally do this. And provide patients with secure application programming interface endpoints that they can point their smartphones that when done right, we’ve already seen this from Apple HealthKit, is a pretty low friction activity, right? It’s just providing a server endpoint to the database hooked up to your EHR. So this is not an ongoing maintenance. It’s not a human intervention. We want to make this seamless, modern, instantaneous. And that’s what we’ve done in the rulemaking. And I think we have, at this stage, buy in from all of the parties obviously. There was a lot of commotion about some of this that had to be worked through, as you were probably aware.
Gary Bisbee 19:15
It seems like this role is, among other things, a negotiator. You talked about the various parties. How much of your time is actually spent negotiating some point of consensus?
Don Rucker 19:29
Oh, depending on how you count, probably most of it. I’m not sure that’s different than any other management role, truth be told. Management, the government’s a little bit different than managing a corporate thing. Because corporate environment, there’s a little bit of a chain of command, never quite as much as you think. I mean, if you think you really have a chain of command, you’re probably in a somewhat unique thing or not long for the world where you’re working. That’s been my observation over the decades. But in government, obviously the civil service employees are in a funny kind of way, free agents. Now ONC is wonderful. It’s a new agency, people are very mission driven. So that’s not an issue, but I think other government agencies, it’s my understanding, that that has been. And then it’s an education thing, really, in getting all of the folks involved and sharing with them what other folks’ needs are. Part of the outreach is, the public speaking is really getting people to think about, I think in pretty much every presentation I did or talk, there was parts of it that were letting everybody know what other people’s needs were, right? So I know you want this, but don’t forget that those folks may want something else or will want something else.
Gary Bisbee 20:47
Let’s turn to a discussion we had briefly before and that is the role of Big Data, particularly at that interface between the providers and the payers. And we can talk on down the line here about the personalization aspect of that because that’ll bounce up against it too. But what about this Big Data and the role it’s going to play in the provider world and the provider payer interface?
Don Rucker 21:12
We’ve just talked about the substrate for getting the app economy into healthcare which will no doubt be transformative in the same way that the app economy has transformed much of the rest of our lives, whether it’s travel, banking, entertainment, sports, retail, all of those things. That will happen in healthcare that arbitrage opportunities that are too large. The other thing that we focused on with these API’s, we heard a lot of complaints interestingly enough, that providers weren’t able to get at their own data, interestingly enough. And that’s from a computing standpoint in the history of EHRs, it’s sort of understandable, these technologies have histories and trajectories. But part of what we did is have FHIR, so Fast Healthcare Interoperability Resources. So these are the modern API class that uses RESTful and JSON and modern internet techniques to actually have what we called, I probably should have named it something else, but in talking with Ken Mandl at Boston Children’s, we were talking about and I called it, “Oh, yeah, like a Bulk API for bulk data.” I was shocked to find out that all the prior work was for just one record at a time, which to me as a database person is like, “What? You have a query that only returns one record?” And this was so unfathomably primitive to me that I couldn’t even imagine it sort of happening. And so then the question was what to do to get that in as well. So working with folks, Ken Mandl huge leadership here, a lot other folks, Josh Mandel and at Microsoft now. And HL7 we got through the Bulk FHIR API so it’s part of version four, the HL7 FHIR standard and we put it in as a requirement in the records. That will allow access to populations of patient data. Now to be very clear, because I know the next question in people’s mind is, “What? They’re just going to let me rummage around for data and EHRs on thousands of patients?” No! So the individual right of access to you put your smartphone at your provider’s endpoint using the password you have for your portal, which is how that works under something called OAuth 2, a security protocol. That is under your individual HIPAA right of access. Most data that’s moved in healthcare is actually moved for specific purposes of treatment, payment, operations by this concept of covered entities, so providers for the most part and payers, and then third parties who are quote, “business associates,” those are all terms of art in the land of HIPAA. But the bottom line for the audience generally is any transmission of this data is a signed, written, accountable contract between people who have a clearly, legally defined role to this individually identified data. So as happens now, it’s just making it more efficient. That’s the underpinning, the Bulk FHIR API. That’s the tech, so what does that mean? Well, I think everybody has seen TV, news clips, read some articles, but much of our world is fueled by Big Data. If you have used Google or Amazon, which I’m positive is 100% of your audience, behind the scenes, all kinds of Big Data tools have been worked on to present that. And Big Data volume, variety, velocity in healthcare, don’t forget, right now we do not have great ways of paying for healthcare. And we’ve been on this 20 year search for value in healthcare, since circa 2000. And the things we’ve come up with are very narrow and really don’t bear any relationship to what we want as consumers and value for the dollar. They were the best that it was at the time, but if you look at the things we’ve put in as proxies for value, whether these very narrow, heavily politicized quality measures or provider and patient burdens like prior authorization or this cumbersome, ginned up, fake for want of a better word, documentation, these E&M things. None of these things really are good. And so we’re screaming for new ways to analyze what we’re getting. If you’re a payer in healthcare today, it’s worth pondering. So the payers who buy care on our behalf, today, they only have four ways of deciding what to buy on our behalf. And none of them are particularly good, right? So they can go on these narrow quality measures. It’s like you’re going to buy a car based on one single feature, right, the color of the rear seat or something. They can go on reputation – it’s Hopkins, Mayo, pick your folks. They can go on narrow network concept – these are the cheapest people and they’re licensed, so we’re going to use them. Or, they can go with, in many cases are the oligopoly delivery systems that have sprung up throughout the country and your audience knows who they are. And the trick there, as we know, is to become large enough that you have to be a network. And then you go from being a price taker for employers and payers to a price setter. Well, none of those four ways of paying for healthcare is anything that we as consumers want, which is why healthcare takes up 20% of the GDP. With Big Data, with these API’s, for the first time ever, you’re going to have robust computational ways. Again, they both have to agree, the payer and the provider have to agree. But for the first time ever, you’re going to have the opportunity to have true, broadly encompassing rich computation around value and performance. It’s going to revolutionize healthcare. And it’s part of what we did in the administration on transparency, not just on price, but also on the product. So I think it is the modern way the rest of the world works. It’s a bit of a sleeper thing. I don’t think people quite have put all these things together from a provider system point of view. I don’t think people quite realize how this will very likely play out.
Gary Bisbee 27:52
I think you’re right on that. What’s the time frame for our listeners? So over the next 3 years, 5 years, 10 years, when will this really begin to make an impact?
Don Rucker 28:03
So the API requirement for both the Core Data for Interoperability, which is that standard, heavily formatted data, the Cures Act requires all data. That’s going to be ended December ’23. But the Core Data which is formatted data, so med list, problem list, allergies, is ended December ’22. And the same for the Bulk FHIR API’s. These things have a cycle time. You have contracting time, you have thinking time, you have product time. So I would say that timeframe plays out, and my guess would be in 4 or 5 years.
Gary Bisbee 28:34
That’s very interesting. We’ll look for that for sure. That’s going to have a major impact on everybody. Would you talk for a moment about the personalization, the consumer. What’s the benefit to the consumer of having the new data and data that’s more accessible?
Don Rucker 28:54
So the sort of prior ONC rulemaking required portals. And that was really the best technology. I mean, now we’re only going back a couple years, but that was the best technology available. But we know today in this sort of smartphone world that the thing that consumers want is a little bit of goofy word called agency. Consumers want power. They don’t want to have the data sitting somewhere else under somebody else’s control. They want the data on their platform, if you will, their smartphone with apps of their choice so they can analyze, or their apps can provide them whatever data informed services they want. I think there’ll be all kinds of entrepreneurial stuff here. It’ll probably start with just smarter EHRs, EHR proxies. But for folks with major illnesses, it’ll be very disease specific things. There’ll be recommendations. I think all of these things will be infused with price transparency, on some level sooner or later, alternatives in care. The phones, of course, are heavily instrumented. So I think it will also be the medium for richer inpatient generated data, telemetry monitors, smartwatch type of data. And with all these Internet of things, this will be sort of the central platform to aggregate all of that. And it will allow healthcare to be continuous with us as opposed to just going to the doctor visit every 3 months, 6 month, year, what your situation is. I think it will make healthcare a more continuous, integrated, seamless, under the covers activities, which should have a huge impact on prevention, right? Because, as we know, maybe not modulo COVID, but ultimately, even in the year of COVID and even for the people who have nominally died of COVID, most of that was underlying chronic illness that was really at the root of it. And in a world where we have that, I think human creativity will be simply awesome here. I hope I live long enough to see it all, but I think creativity will be just stunning here.
Gary Bisbee 31:08
Yeah, I agree with that. I think you will live enough because I think it’s coming and has been for some time, as you know. Back to the agency, Micky Tripathi is following you as a national coordinator. What advice would you have for Micky?
Don Rucker 31:23
I think there’s a bipartisan. I’ve had a discussion with Micky about some of the operational issues and stuff, you know, which we’ll just leave there, very cordial discussion. I think the beauty of this has been that it’s been a remarkably bipartisan activity. I mean, the things we just talked about, including a lot of the stuff we’ve done with health information exchanges and COVID and public health data and pro competitive, pro social determinants of health as a platform. All of that has been bipartisan and, essentially, everything I worked on was started by the prior administration. So I think there’s a fair amount of continuity here. Obviously, emphasis may change, times will change, situations will change. But I think there’s a lot of consensus. And obviously, all of these things were done with a whole team of people, all of whom are still there, working on things and provided input before and will provide rich input as they have in the past.
Gary Bisbee 32:19
Don, this has been a terrific interview. We need more time because you’ve got such in-depth knowledge and many of these issues are so critical to healthcare. But let me wrap up, if I could, with the question, if you were to think about your legacy, and you’ve got a long way to go so you probably don’t think about that, what would you want your legacy to be at this point?
Don Rucker 32:44
I have spent my career, as we’ve just discussed, probably too grand of length, trying to infuse healthcare, medicine and healthcare more broadly, with modern data, modern approaches, maximize the information for science, and get people as empowered to be in charge of their lives and their bodies. And many, many, many people have played a part in that. And I’ve been pleased to have an opportunity to work with all those folks in advancing that.
Gary Bisbee 33:17
Well said. Don, thanks so much for being with us. We hope you’ll come back and visit again. And take a couple of days off, will you, after all that time at ONC. Appreciate it.
Don Rucker 33:28
Thank you, Gary.
Gary Bisbee 33:30
New episodes will debut every Thursday. Join me in conversations to gain advice and wisdom from CEOs, presidents, and healthcare experts. Healthcare leadership is hard work, but it becomes more manageable as we learn from the remarkable lives and careers of our guests. I’ll see you there.