Regulation as a Forcing Function for Innovation feat. Micky Tripathi, HHS' National Coordinator for Health IT

I recently spoke with Micky Tripathi, National Coordinator for Health Information Technology, about assessing value in digital health / healthcare IT investments and how federal action can help  coordinate progress in healthcare technology. We discussed the role of federal policy, highlights from recent ONC legislation, and opportunities ahead. 

Join us on a journey through Micky's unconventional path from political science to spearheading health data interoperability initiatives, and glean insights into the transformative impact of federal regulations like the 21st Century Cures Act on the adoption of healthcare IT.

In our candid exchange, we scrutinize the evolution of health information exchange networks and the essential role of governance in safeguarding data integrity and trust. With the ONC's craftsmanship of the SDOH playbook under the Biden-Harris administration, we break down the quest for health equity through data integration initiatives like USCDI and TEFCA. 

Having established a digital baseline, the industry now looks to innovate upon that core to truly begin unlocking value from these assets. There is still so much untapped potential to utilize health data for major initiatives, such as the Cancer Moonshot program or solving for the maternal health divide. 

For those passionate about influencing healthcare policy, we close with Micky's advice on how to wield your voice through public comment opportunities. Tune in for this  opportunity to hear from a vaunted pillar of healthcare IT policymaking, and learn about his future vision for digital health.

Transcript

Micky Tripathi: 0:00

People say this all the time we're going to reduce the cost of care. It's like, well, we're not really going to reduce the cost of care, we hope to reduce the increase in cost growth. We hope to be more productive or efficient, meaning that we are getting more health care quality per unit dollar that we're spending. But those aren't obvious things. Those are not obvious things to measure, particularly when health care quality has got many, many, many non-monetary aspects. What is the value of an improvement in my quality of life so that I have managed diabetes, for example, or I don't have my leg amputated or any of those things that are about my quality of life? How do we actually measure that in a way that enters that value proposition equation in the same way that it does when I purchase a computer or a TV, where you can have that price quality chart and it's pretty easy to make those estimates of demand, supply and what additional value you get for that next increment in capability in my TV or my computer?

John Moore: 1:09

Welcome back to the Chilcast, a health care podcast from Chilmark Research, helping health care leaders make the best decisions for the populations they serve. Welcome back to the Chilcast. I'm the managing partner of Chilmark Research and your host today, John Moore III. This is the fifth episode of our mini series delving into how thought leaders representing different industry stakeholders think about assessing the value of digital health and health IT implementations. So we appreciate everybody that has been tuning in and welcome to our new listeners.

John Moore: 1:47

This series came about as part of a new collaborative effort, the Health Impact Project that Schillmark convened earlier this year with Curtis Peterson of King Fisher Advising Marie Coppola of Horta Health, and Pam Arlotto and Susan Irby from MyEster Strategies.

John Moore: 2:01

After hearing ad nauseam over the last couple of years how important it is for new technologies to show efficacy in the current economic climate, we decided that it was time to come up with a better metric for evaluating the impact of technology than a standard, oversimplified financial calculation like ROI. This series is intended to catalyze industry conversations that we see as necessary to reach consensus on a new model of value that C-Suite's care organizations, payers, technology developers, investment firms and more can apply to their own initiatives. So please be sure to follow us on LinkedIn, via the Health Impact Project page, for updates and new contact, and be sure to subscribe to this podcast to not miss any episodes as they are released. So for our fifth installment, I am pleased to introduce none other than Micky Tripathi, PhD, current national coordinator of health information technology at HHS, where he leads the formulation of federal health IT strategy and coordinates federal health IT policies, standards, programs and investments. This makes him arguably the most influential public servant in our healthcare IT space.

Micky Tripathi: 3:08

Hi, john, really glad to be here.

John Moore: 3:11

It's our pleasure, really looking forward to this conversation. So, for those of you not already familiar with Mickey, he is one of those industry heavyweights that generally needs no introduction, but it's definitely important to provide a brief history of his career as valuable context for what we'll be discussing today. Dr Tripathi brought over 20 years of experience across the healthcare IT landscape to this federal appointment. He most recently served as chief alliance officer for Arcadiaio, a healthcare data and software company focused on population health management and value-based care. He was the project manager of the Argonaut project, an industry collaboration to accelerate the adoption of FIRE, and a board member of HL7, the Sequoia project, the Commonwealth Health Alliance and the Caron Alliance. So all very interoperability, heavy initiatives and standards-based bodies.

John Moore: 4:01

Mickey served as the president and CEO of the Mass E Health Collaborative, a non-profit health IT advisory and clinical data analytics company.

John Moore: 4:10

He was also the founding president and CEO of the Indiana Health Information Exchange, a statewide HIE partnered with the Regan Streef Institute, and he's also an executive advisor to investment from LRV Health, who we actually spoke with on our last episode, and a fellow at the Berkman Klein Center for Internet and Society at Harvard University. These were all roles that he had before coming to the Fed, which is now his only current role. He holds a PhD in political science from the Massachusetts Institute of Technology, a master of public policy from Harvard and an AB in political science from Vassar College, which also happens to be my alma mater. So go Brewers, not that sports are a really big thing there. Prior to receiving his PhD, he was a Presidential Management Fellow and Senior Operations Research Analyst in the Office of the Secretary of Defense in Washington DC, for which he received the Secretary of Defense Meritorious Civilian Service Medal. So yeah, really excited to kind of go deep into Mickey's career and what he sees the role of the federal, you know, regulation and involvement with health care, it, adoption, going forward.

Micky Tripathi: 5:22

Great.

John Moore: 5:24

So let's start with kind of your earliest days. You got into health care IT after you received your PhD in political science, so that seems like a pretty non-traditional path, but I feel like that's how a lot of us end up in health IT. It's not necessarily where we intended to start or end up in, but would you mind sharing your story how you went for PhD in polypsi and then, you know, ended up being as influential and kind of the interoperability in health care IT world.

Micky Tripathi: 5:50

It is definitely non-traditional, but I guess I've always been, you know, sort of very intrigued by and interested in areas that kind of bring together technology, technology slash science, policy and business. It wasn't a deliberate strategy, it's just like looking back. It's where I sort of see that I've, you know, sort of found myself. I worked in the defense industry, in the Pentagon, for a number of years and found myself sort of in the middle of that, you know, right at that nexus as well, you know sort of thinking about the economics of weapons procurement, well, real asset management and weapons procurement and policy and you know sort of science and technology piece of that. So in some ways was, you know kind of you know very similar to where I ended up in health, it and my in studying political science. I was very focused on. I mean, I started off pre-med in college and then in studying political science I was much more oriented toward the economics and quantitative methods side of the house. So I was in the political science program at MIT but I did the doctoral requirements for the economics degree as well and taught statistics. So I was always like a weird, you know sort of more technically, quantitatively oriented type. And then once I thought that I was going to go teach, but then, as I sort of looked at what teaching jobs might be like, realized that that was really not going to work out. I already had three kids at that point. I got my PhD a little bit later in my career. I already had three kids, was unwilling to move from Boston and so had to look, you know, for other opportunities.

Micky Tripathi: 7:35

And right around that time this was like the late 90s, early 2000, like late 90s the sort of the dot-com era was really peaking and the management consulting firms in particular were recruiting very heavily, particularly outside of the MBA cohort, which is where they typically went. They were starting to look at MDs, jds and PhDs. And I got caught up in that, got very interested in the Boston Consulting Group as one firm and that's where I ended up. So I was there for like five or six years and that's where I got really interested in sort of getting my hands really dirty and sort of the business elements or the business drivers of value. But even there was gravitating toward the areas that had a significant public policy dimension. So one of the last engagements I had was working out in Indianapolis founding the Indian Health Information Exchange and that's what really got me sort of involved in Health IT and when I decided that this was kind of the industry that I wanted to focus on.

John Moore: 8:40

Okay, I know that's fantastic context, especially given that the purpose of these conversations that we're having are to think about kind of the economic impact, the role that healthcare technology and data technologies coming into healthcare can have on truly unlocking new value drivers in the healthcare sector. Because, as you know first hand, inefficiency and administrative ways are two of the biggest drivers of kind of unnecessary expenses in the healthcare space, and technology is primed to help with those specific problems. So, with that context and the purpose of this endeavor to be developing a new model for assessing the value that technology delivers in any healthcare context, any use case you know that these are very broadly differentiated use cases and that is no easy task. So, given your economics background and understanding the public health aspect of policy, how do you think about defining the value of technology? How do you think about ensuring that what people are focusing on and what you can drive people to focus on in your role, is actually going to have a substantive value, impact and outcome for people that are deploying these new technologies?

Micky Tripathi: 10:02

Yeah, I mean, I think you know we've got a significant challenge in healthcare in the US which is just the fragmentation of, you know, of our healthcare system, and I'll put system in quotes. And you know, in a country as big as ours and as fragmented as ours On almost every dimension you can think of, and certainly you know, healthcare is, you know, is, you know, probably the biggest example of that, if not one of the biggest examples of that. The challenge that we have with almost anything is you know what in political science and economics they call a collective action problem, which is how do you get an industry to move forward in a more, you know, in somewhat of a synchronized way when it's very, very fragmented? And you know it's not as if you can just get, you know, seven or eight large companies in the room, like you can with banks or like with airlines, and get an industry agreement among them. Usually they themselves, you know, are part of driving. Because they can, you know the industry side, they're able to solve a collective action problem themselves or with, you know, relatively little help from the federal government.

Micky Tripathi: 11:13

In healthcare we don't have that. I mean, if you look at you know, we have large provider organizations that are nationwide, but in most cases they're small in most markets. Yes, united Health Group is very big in Massachusetts they're not really a driver of.

Micky Tripathi: 11:29

You know what happens in the Massachusetts market and you know the same thing for Ascension Health you know very big national integrated delivery network Don't really drive a whole lot in, you know, in many, many markets, indeed most of the markets in the country. So you've got this. You know this anomaly that we have some very big organizations. Some of them are nationwide organizations or maybe it's best to think of as multi-regional organizations. And the challenge that we have in healthcare is, you know, how do you get coordination to have the industry drive forward, particularly in areas of technology that can help to drive the kinds of efficiencies, the kind of higher value that we've seen in other industries?

Micky Tripathi: 12:14

And in the absence of market type of orchestration you need, I would argue, you know, in the healthcare industry you need the federal government to be able to play a role in kind of tying it together, providing some of that systemness that we don't have and I think that that's partly, you know, sort of owing to the federal government's presence in almost every market. So you know, it may be that United Health Group isn't big in every market, but Medicare and Medicaid sure are Every single market you can think of. There are providers who are a part of Medicaid, you know, serving members of Medicare and Medicaid. So it's one aspect, just the participation that only the federal government participates in almost every market that you can think of across the country. The second is just that regulatory dimension, that the ability to judiciously apply regulation that helps the market itself move forward and overcome some of these collective action problems I think is a critical role of the federal government.

John Moore: 13:13

Okay. So getting back to the value piece, how do you think about the government actually like defining the value that people should expect from the various initiatives that you're trying to drive forward? So you know, interoperability it's almost impossible to assign a specific ROI to having data flow. So how do you think about value when you are not thinking necessarily about dollar and cent?

Micky Tripathi: 13:36

Yeah, I mean, I think you know, for some of this there was, you know there was a lot of effort over a number of years to define the ROI you know for interoperability. There were a lot of studies going back to it was an organization called CITL, the Center for Information Technology. I even have their study here on my bookshelf. That like like tried to do a very specific value proposition dissection of what's the value proposition for payers?

Micky Tripathi: 14:03

what's the value proposition for payers large providers, small providers what's the value proposition? And try to sort of craft it as almost like a business strategy and to see if they could thread the needle you know to have.

Micky Tripathi: 14:14

you know that sort of be this epiphany for all those stakeholders of ah, there it is. Now I will, you know, sort of, you know, make the investments. Because I see the ROI and I think after a while a number of us just threw up our hands and said that the health care is too fragmented and the economics are too opaque for us to be able to, you know, really, you know kind of drive it in that way and so we really have to, you know, sort of go on the assumption which I think is a very, very good assumption that interoperability is good. It is good and it will deliver an enormous number of benefits on a lot of different dimensions, and it is a public good in the economic sense. So the economic definition of public good is something that benefits society but that no actor finds it in their rational self-interest to make the investment right, the tragedy of the commons, the whole thing right. I mean, all of that is just different elements of a public good story.

Micky Tripathi: 15:12

Interoperability, I think, falls into that category. Even before that, electronic health records fell into that category, people weren't willing to invest in electronic health records, which is why we had industry stalemate for a number of years, and it wasn't until Medicare and Medicaid essentially through high tech as the only players across the country who had an interest in all markets to invest in their supply chain that it basically broke the prisoner's dilemma, you know, or the public goods problem. However you want to sort of think about that they were able to break that stalemate to say, well, we, the federal government, can invest in that supply chain for our business purposes, which is Medicare and Medicaid, but that will also have spillover effects to the entire economy. And so being able to sort of break that open, first for electronic health records and then for interoperability, is kind of I think you know more of the approach that we're taking. And you know, and I think you see it in the 21st Century Cores Act, which basically said you know, interoperability is the natural state, which is essentially what that said.

Micky Tripathi: 16:14

You know, the whole idea of information blocking is that information should just be flowing. That's. You know, that's the way it was intended, you know, but from by whatever higher being you think defines these things, that data and healthcare data should just be natural flowing, and the idea of information blocking is that you need to have a very good reason to interfere with or prevent that information from flowing. And they weren't. You know, they weren't thinking about oh, I need an ROI calculation at that point.

Micky Tripathi: 16:45

It was just that you know, value will come to everyone through information flowing and for those who feel that it upsets their markets. Those are organizations who are basically making profits on the inefficient side and obviously, as a federal government, we're, you know, going to try to prevent that.

John Moore: 17:07

Yeah, inefficiencies or potentially anti competitive behaviors that they don't want exposed Obviously.

Micky Tripathi: 17:15

No different than any other industry I think that's something we always have to remember is it's it's a business in the US. It's a business. It's a business. We'd like to think that certain aspects of it are a higher calling and you know, my parents are doctors, my daughter's doctor. There is a higher calling there, for sure, but the basic drivers of you know, of the, of you know sort of the industry are business drivers and we just have to remember they're gonna act like other businesses, act in many, many ways, not not always, but many, many ways.

John Moore: 17:45

So when we think about the hard kind of value of interoperability and that being a bit Difficult to define very specifically the government's kind of way around, that is, to your point, the info blocking rules. So I've looked at the info blocking Disincentives that you guys published this year, so congratulations on getting that final rule out there. But I think for a lot of people the way that it's worded like with a lot of federal Legislation, a lot of rules it's worded in ways that can be a little bit difficult for a layperson or for somebody that's not on the legal side to understand. So could you give us a concrete example of what the penalties, the disincentives, would actually look like? Edit, you know an organization of some specific side, sure?

Micky Tripathi: 18:30

And so the first set I should you know, we should be clear and this was in, you know, secretary, by Zara step statement with the release of the of the property disincentives, as it was called, draft rule was that this sets up a framework For this initial set of disincentives, with the anticipation that there will probably be more that fit within to this framework. So the first was establishing how are we going to approach this from a general regulatory policy perspective, and establishing that first and then saying here are the first set of you know of, of appropriate disincentives. So the three that are proposed right now are in, are in the CMS program. Again, there's nothing that limits the appropriate disincentives Program from being limited to CMS. That could really be any agency in the Department of Health Services and as the biggest grant-giving organization in the world, there are many, many agencies that that do have programs that you know that that Organizations do receive funding for. So but you know, the first set of disincentives you know comes through the CMS program and it it looks at our focuses on three.

Micky Tripathi: 19:41

You know, three different types of actors. So in information blocking there's the idea of actors who is responsible for not information blocking, and there are three name types providers, health information networks and Certified technology developers, which would be, like you know, electronic health record vendors. So those are the three actors who are named, and so in identifying, electing a set of appropriate disincentives, you first have to ask yourself well, where are there government programs that actually Involved in some way those particular types of actors? And of course, you know, once you get to providers You're talking about, you open that box up and then it's like, well, there's hospitals and there's physician offices, and there's federally qualified health centers and there's LT pack and there's behavioral health and right and so, and each of those has different programs associated with them, right in different agencies. Samhsa works with you know, something's used providers, and HRSA works with federal health centers and CMS works kind of with all of them.

Micky Tripathi: 20:40

And yeah, so anyway. So that's kind of the you know sort of the more detailed work you have to do is say, well, each actor in theory needs a penalty associated with them, and so how do you work your way through that? So the first, you know, the first set of appropriate disincentive proposals are focused on three general types of actors. One is hospitals, emu eligible providers second category, which is basically a physician offices or physicians working in an ambulatory setting. And then the third would be accountable care organizations and, and, and the first two, without going you know deep, deep, deep into the weeds on it, are essentially a proposed appropriate disincentives which would, you know, sort of limit the, the score that they can get for certain CMS Incentive programs, so promoting interoperability, for example, or the MIPS program that you know that maybe mumbo jumbo to lay people, but Physician offices and hospitals absolutely know what those programs are. And those programs are programs where they can get incentive dollars for using, you know, electronic health records in certain ways that will benefit interoperability. And so there's a you know sort of a straightforward scoring mechanism they get for doing different things and For the physician offices in hospitals.

Micky Tripathi: 22:00

That basically would say, if you were found on investigation by the office of inspector general, to be an information blocker, as it were.

Micky Tripathi: 22:10

That CMS would then have the the ability to essentially for one part of your score, which is about interoperability, I think are using health information exchange, or I think it's that categories Would essentially say that you get a zero score in that category, and so at the end of the year, once you're going to rank all that up, you know your total score, or then calibrates to how much incentive payment do you get. So essentially, we'll put a cap on you know on how much incentive payment you would get, so you know the estimates. When we provide this in a rule might be, you know, and it depends on you know the size of the organization. So it could be like for an individual provider, it could be something like if you're just a solo practitioner on the very low end, that might amount to less than a thousand dollar penalty, which is really not a penalty per se, it's money that you could have gotten that as incentive, but you're not getting right.

Micky Tripathi: 23:03

But it could amount to like for a hospital or a large physician practice it could amount to something that's in a hundreds of thousands of dollars. So you know, kind of read it varies. I mean that way for the ACO's the proposed penalties a little bit different. It would actually preclude an ACO organization from participating in the program for up to a year. Is the proposal, which again is, you know, pretty significant Penalty.

Micky Tripathi: 23:27

I mean, if you're an ACO, you know, in in an MSSP ACO, for example at CMS, you know that's that's a big deal for sure. But but I think you're supposed to have bite right, I mean there's. So anyway, you know there are many, many more details, but hopefully that gives a sense just broadly of you know how those opposed incentives work. And again, this is a draft rule. So you know we welcome comments or you know we're it's a department rule, it's not no one see rule. We were asked by the secretary's office to just basically have the pen because it involves multiple different agencies. But you know we look forward to, you know, to people's feedback and comments.

John Moore: 24:05

So do you think that those Disincentives will end up getting stronger over time? Because right now they feel fairly soft and I get the Sense that part of that's because it's still taking people a little while to get to the point where they have the tools, they have the infrastructure to not be blocking, not be providing info blocking. So do you think that over time you will start adding to that disincentive? I mean, a thousand dollars, that's just that's a write-off right for some certain smaller providers, and even a couple hundred thousand dollars isn't a huge impact to the revenue stream for a lot of these organizations. They're bringing in, you know, hundreds of millions of dollars in that patient revenue. So Do you think you'll have to implement something with a little bit more bite going forward, you know, after this initial rule gets pushed through?

Micky Tripathi: 24:50

Yeah, I mean I think it's, you know it's hard to know. I mean we, you know it's hard to know what's. You know what's soft and what's hard. Because you know there is one other aspect of it that, from a transparency perspective, onc, on our website, will post or publish the names of all the organizations who were found to Be. You know, I'm not in compliance with the information blocking regulations, so there's be a public aspect to it as well which could affect our hand. And you know, and all that, it's about transparency. I mean it's not, it's not disincentive per se, it's about just creating transparency for the market. But there's that dimension of it as well. I think you know we will always, will be closely monitoring it for sure. And if the eye, if you know, if it looks like there's more needed, then I think we would always have the opportunity, you know, to say well, we're gonna up the you know we're gonna up the penalty or find different ways of having penalties that have that.

Micky Tripathi: 25:45

Have you know more bite? If you know If that's, if that's, you know how it looks like it's playing out.

John Moore: 25:51

Okay, make sense. So, obviously, in your role, you're talking to a lot of different lobby groups. You're talking to different individuals, you're doing the speaking circuit, you're hearing, you know you got to keep tabs on what's going on with the market and where people are thinking on. You know the patient side, the provider side, the payor side, everybody. So, taking into account all those conversations that you're having, what are some common themes that you are seeing emerge about how different stakeholders assess the value of health data technology?

Micky Tripathi: 26:22

No, I think in general and I may be just hearing things that I want to hear, so we're always to be conscious of that but in general I feel like there is a lot of excitement to finally start to get some stuff done. But I think we feel like it feels like across the board, there is a sense that we've spent a lot of time converting from paper to an electronic foundation, to a digital foundation, and that took a lot of time and, yes, it was messy all of that. But in something like 10, 12 years we've completely converted the most complex sector of the biggest and most complex economy of the world from a paper-based system to one that is in many, many ways, starting to become digitally native, and that's a tremendous, tremendous accomplishment, and I think people don't get enough credit for that, both on the public and private side for that. But I think, that being said, now we want to be able to say well, yes, you had to get billing done right. Billing has to get done. People have to get paid If you're not, if those systems don't do billing.

Micky Tripathi: 27:35

My experience helping to implement thousands and thousands and thousands of electronic medical records was in those implementation implementations. The minute that revenue cycle had a hiccup was the minute that you lost everyone. They were like time out. We are not doing this. I don't give a shit about your EHR, I don't give a shit about your vision, but I'm not getting paid anymore. So, and that means my nurse isn't getting paid, my front staff isn't getting paid and my janitor is not getting paid. No one is getting paid. So you need to make sure that, first and foremost, we're getting paid. I know people criticize oh, these are billing systems. It's like well, all right, let's ask every one of you do you like getting paid or not Not getting paid? If you don't like getting paid, great, fantastic, come and volunteer, implement this technology on behalf of society and don't get paid in the process. But so people need to get paid.

Micky Tripathi: 28:25

Yes, we need to convert from digital, from paper, to digital. Yes, but I think all of us have higher ambitions for this. How is this actually going to help with curing cancer? Cancer moonshot goals, 50% reduction in the next 10 years, or I forget the specific goal in cancer, those kinds of things.

Micky Tripathi: 28:43

Improvements, significant, substantial improvements in public health, maternal health all of the things that we're kind of focusing on, I think, is where there's genuine excitement Just say let's get to that next level, let's get to the level of being able to say we're now past the trough of disillusionment in the Gartner hype cycle and we're on the path of the slow of enlightenment and let's sort of grab that opportunity. So that's kind of where I feel like there's a tremendous amount of excitement and it sort of comes through and enthusiasm we've gotten for the US CDI, that minimum data set, us Core Data for Interoperability both in the market as well as across our federal agency partners. The enthusiasm we're getting for Tefcom that just went live and happy to talk more about that, and the enthusiasm that we're getting for all the work we're doing to make sure that FHIR API adoption is moving forward aggressively to finally have healthcare firmly discover the internet in the ways that almost every other sector.

John Moore: 29:44

I mean it's still kind of crazy that not everybody has online scheduling tools for their organization yet. Right, getting back to that kind of payment piece, so real quick, kind of sidebar question that isn't super relevant to the rest of this discussion, but do you think that RCEM solutions are going to be necessary post fee for service? So if we're actually able to make a full transition to value-based care, do you think that those RCEM technologies are still going to be relevant?

Micky Tripathi: 30:12

Yeah, I mean, I'm not an expert in that, but in theory you can imagine that they would take a different flavor. But we're pretty far away from our goal of having everything in value-based care. So I think there's going to be a new RCEM solutions for a long time.

John Moore: 30:32

No, absolutely, but thinking about that being one of the first big needs for digital and why a lot of the EHRs and core systems are so flat and not necessarily systems of engagement or, more just, systems of record. But as we think about that shift away from fee for service, hopefully I see some of that investment going more towards tracking, value measures and the other kind of performance metrics that are going to be tied to value-based care, and I think that's a really important capitation.

Micky Tripathi: 30:59

But to your point, that's just a different flavor of RCEM. My experience in implementing was pretty consistently been that when organizations move from fee for service to some kind of value-based purchasing arrangement, whatever it is, is the minute that they really start focusing on interoperability, because it's moved from overhead to my cost of good soul essentially it's a part of doing business at that point and to delivering value, and so I generally agree with you that that's sort of one of the biggest drivers of being able to think more creatively and innovatively about how technology can really deliver value versus just getting the bills paid.

John Moore: 31:51

Yeah, enable new models of care, enable just performance improvement, ongoing consistent performance improvement, specifically, et cetera. So, getting back to your training as an economist, why do you think the value assessment has been so hard to achieve in a consistent manner in the healthcare tech space for so many years? Obviously, it's a relatively immature space, so that's part of it, the immaturity. We didn't have the data to effectively assess the impact. But what else is going on here that's made it so hard to actually assess the value of IT and healthcare?

Micky Tripathi: 32:29

Well, I think it's a little bit of what we were talking about. That, first off, it's in a fee for service. World interoperability and indeed in many parts of health, information technology are just overhead. I mean, you're basically in a cost plus contract kind of arrangement and there aren't huge incentives to get more efficient and or deliver higher value, and so I think that's just one of the challenges that we have. And again, I don't think it's different than any other business. It's just that that's kind of the way that a lot of the economics flow in healthcare. So I think that's been one challenge for sure. I think that the opaque nature of healthcare economics is also right, and this is like in every healthcare economics 101 or in every economics 101 course you'll get is well, here's how markets work, and then let's talk about markets that don't have some of these core sort of principles. So meet these core principles of plausibly efficient markets, and healthcare and defense are the two right that every single economics processor across the country teaches.

Micky Tripathi: 33:45

And the part of the healthcare equation is that consumers are shielded essentially from the purchase decisions that they make in certain significant ways, that there are information and symmetries. It's really hard for them to assess value and to assess incremental value for the incremental value of the next unit of payment. And also there is a very asymmetric view of risk, which is actually very similar to defense, where I did a lot of work with the defense industry I was talking about before. It's very similar in defense right, where you don't have sort of a symmetric idea of risk. No-transcript risk, wait a minute, I increase my risk of dying five percentage points. That's not good, that's really not good. In the same way, with defense, we're always like wait a minute. Every increment in risk you're adding is a risk to our entire country and our entire way of life. That's not good, right? So we do everything that we can to move away from that risk and to be very risk averse.

Micky Tripathi: 34:47

On that dimension, healthcare is very similar, I think, and individuals behave that way. So I think that's part of the challenge is that it doesn't have those simple or relatively simple kinds of value metrics that we can apply in other parts of the economy. I think the other part of this which makes it especially challenging is that it's a very fast moving technology space and so for anyone who is trying to say well, I'm going to cut, people say this all the time we're going to reduce the cost of care. It's like, well, we're not really going to reduce the cost of care, we hope to reduce the increase in cost growth. We hope to be more productive or efficient, meaning that we are getting more healthcare quality per unit dollar that we're spending.

Micky Tripathi: 35:47

But those aren't obvious things, right? Those are not obvious things to measure, particularly when healthcare quality has got many, many, many non-monetary aspects. What is the value of an improvement in my quality of life so that I have managed diabetes, for example, or I don't have my leg amputated, or any of those things that are about my quality of life?

Micky Tripathi: 36:16

How do we actually measure that in a way that enters that value proposition equation in the same way that it does when I purchase a computer or a TV, where you can have that price quality chart and it's pretty easy to make those estimates of demand supply and what additional value you get for that next increment in capability in my TV or my computer. I think all of those things make it really hard to have that kind of calculation.

John Moore: 36:48

Yeah, I completely agree. That's something that at Chillmark we've been watching play out since we first entered the space. It's a conversation that hasn't been as tantamount to the activity in the industry, because for a while there we founded the company shortly before Hightep got passed For a good chunk of the last decade people were focused on that area, on meaningful use, on just core infrastructure getting implemented, getting the government incentive payments for implementing this core infrastructure. I think that now that some of that money is dried up and there isn't as much new money coming in for core infrastructure investments, you are seeing the tight margins and the financial constraints of healthcare organizations really come into play, with more of these decision-making and having to much more align any new investments with their own organizational strategy versus some outside strategy that's being pushed onto them.

Micky Tripathi: 37:44

Right, I think that's the nature of the public goods problem I think you just said it which is that no organization for all of these organizations they feel like, well, it's not, how much additional value do I get by that next incremental investment in interoperability to get that next increment of information? And for most organizations they'll be like pretty low. I'd rather just ask the patient Right which is not the best way of doing this, and I would argue that that's one of the aspects of public goods that the federal government needs to sort of help to solve that inefficiency, that market failure or dimension of a market failure. That is a public good. What is the value to our country of having an effective public health system? What's the value to our country of having patients have as much information available to their providers to provide the best possible care? Those are all public goods that the market itself is not going to value in the ways that we, as a country, I think should want the market value.

John Moore: 38:52

Yeah, I think that's a really good way of putting it. And so that kind of gets into the next section of this discussion, which we're recording this a few days before Christmas 2023. And last week you guys had a very busy week with your annual ONC conference, the first one since 2019. And you had a whole bunch of news coming out over the last week and a half. So QHINZ went live. Hti one final rule came out. You got your AI transparency element got added into HTI one from the initial proposed rule. So can we start at the top and just you know what's the big deal about QHINZ? Just a quick summary of why this is so exciting, why it's been such a big focus of the government for the last few years making this happen and getting us to the point that we are today.

Micky Tripathi: 39:38

Sure, really, since the founding of ONC in 2004, there's been the vision of essentially a nationwide network for medical record interoperability and you know there's a need for some type of governance for that. If you look at any other network, any other industry, there are networks that provide that backbone of assurance for reliability, for trust, for security, for, you know, collaborative problem solving that are important to you know, make sure that you've got that you know sort of the backbone to have information sharing, to make sure that information gets where it needs to get when it's needed. And if you look at, you know, banking system, for example, ach payments, right, there's a huge, you know sort of infrastructure behind the scenes that makes sure that when I do my Benmo payment or I write a check or I do a credit card transaction, that all that gets reconciled on the back end and I don't have to worry about it as an individual. We don't, you know we've been building toward that. In healthcare we had some HIEs early on, indian Health Information Exchange, which I you know, which I've found, you know was one of them. And then we had the ONC program which looked from a geographic perspective and sort of made an assumption that, well, each state will have an HIE and then those HIEs will get, you know, connected up as it turned out. You know that isn't the way it worked. Some states, you know geography was a good basis for health information exchange network in some places, but in most places it actually wasn't a great you know sort of dimension of affinity or you know sort of a vector of trust, however you want to think about that. And so then we moved to the next level, which is you've got some state you know on regional HIEs but more nationwide type of networks forming the health exchange which spun out from the federal government. Care of quality, the Commonwealth of Health Alliance, epics, care Everywhere, for example, obviously was, you know, was designed for, you know with an EPIC, but all of those you know kind of really being more organic efforts to say, where is the business connection that we have here? And then how do we build on that to create a network to support you know, to serve our participants? So we're at the point now that we've got you know sort of a number of networks and the direction from the 21st Century Cures Act was to, you know, try to once and for all say all right, at this point we need to connect them up so that we have the user experience, the network of networks, user experience, so that whichever network you're on, you will be connected to everyone else for a basic set of, you know, of services, that basic interoperability. And that's what we've been working toward and, again, that's you know.

Micky Tripathi: 42:23

If you look at the phone industry, it went through a very similar type of process. There was, you know, for there was a long time where you know, the old Ma Bell AT&T, you know, covered, you know, I actually know this information because I did some research on it and I like to talk about it. Like, in the early 1900s there were something like 2 million phone users across the country, which itself was, I think, just sort of shocking that there were that many phone users, but something like 50% of them were connected in the AT&T network, the old Ma Bell network, right? So you got about a million or maybe it was a little bit more. Maybe it was like two thirds were connected on the Ma Bell network, one third remaining, one third were covered by over 2,000 networks. So you think about that sort of feels a little bit like we are today, right, you've got a couple of big networks and then you have a whole bunch of small networks. Then the problem for us as a country was to say all right, how do we connect up all those networks? That took like 50 years. In telephone history it took like 50 years for that to all be consolidated in a network of networks type of structure where, whether I use AT&T or Verizon or T-Mobile or Sprint, I don't for a second worry about whether I will be able to talk to someone on another phone on another proprietary system.

Micky Tripathi: 43:41

That's what we wanted to be able to do with Tefka and that was the direction we got from the Congress to build. So that's the importance of these networks. You can think of them almost as like the AT&T, verizon, t-mobile and Sprint of medical record interoperability. You've got to have some organization that's already got a network and you want to connect them up to solve that problem network to network, when they're already providing services within their network. So we had five organizations who stepped forward to do this voluntarily.

Micky Tripathi: 44:11

There was nothing in the 21st Century Cures Act that gave us either funding or authority, meaning the ability to tell everyone in the country you are required to join this network. We didn't get any of that direction from the Congress. So we really needed to put it together as a model that the industry saw as being valuable from an industry perspective, and I think what you see is these five organizations, as well as two who are in the last stages of their implementation. Plus we've got a couple who are in the application stage, two more who have publicly announced very large, influential organizations who have announced that they have submitted their applications and intend to become qualified networks as well. That starts to sort of fill out that idea of we've got some networks that connect with each other. Regardless, if you're a provider, if you're a hospital, regardless of which network you join, you will have the confidence that you can exchange information with anyone else, regardless of which network they're on.

John Moore: 45:08

So can you just give me a quick overview, very brief, of what exactly the data is that is going to be included in the QHINs, because it's not going to be all the data. There's a lot of unstructured data. There's still pending standards coming out for USCDI. So at this point in the development of the QHIN concept, what data elements and what exchange is actually happening on this national network?

Micky Tripathi: 45:36

Sure. So the requirement in theory is EHI Electronic Health Information which is basically the same definition that's used for the information walking rules, which is basically all electronic health information. But we recognize that that's really hard to do when you don't have standards for all of that, and so the minimum expectation, the base expectation, is that what's exchanged is the US core data for interoperability, the USCDI, and that's required by EHR vendors. It's required in various federal programs to be supported for quality measures or other things, so it's kind of the minimum data set of the healthcare delivery system. Already I will note that the USCDI does have eight note types in it as well. So it's not as if the USCDI is only structured data. It's not. It includes notes, eight note types that are required to be supported as part of the USCDI. So that's the minimum expectation, that that's what will be exchanged.

Micky Tripathi: 46:39

Again, the requirement and it's a loose requirement is that you send whatever you have electronically.

Micky Tripathi: 46:46

We just think that we can have a good expectation that everyone can send the USCDI, because that's what most of those networks do today.

Micky Tripathi: 46:52

In some way, shape or form, they send the USCDI and we expect that that would grow over time and certainly the information blocking rules will provide added impetus for people to share more information than the USCDI, because the information blocking rule is not limited to the USCDI.

Micky Tripathi: 47:06

It's limited to everything electronic, everything in quotes, because that's a pretty hard term to get your head around. But as the information blocking rule sort of comes into place and people start to, with enforcement and all of that coming into place, we think that the TEFCA would replace that. Organizations will feel like, okay, I can share more and more of that electronic information in the TEFCA network and then I will be complying with the information blocking or substantial portions of the information blocking regulation because I'm just making the information available and it'd be pretty hard at least for the information that someone's asking for, could be pretty hard for someone to make a case that I'm information blocking If they're on TEFCA and I'm on TEFCA and I'm making this information available. That helps from a compliance perspective as well. So we think that that adds added impetus for people to want to do it.

John Moore: 48:01

Okay, so we're getting a little bit late in the recording session so I've got to jump through some of these a little bit fast. I think in general, most people can look up HTI1 and see the summary that other folks have put out. I'll share a couple of those in the show notes, but can you just give a really quick overview of what exactly is contained in HTI1? And how you perceive the evolution of this? Because the organization has telegraphed out that HTI1 is the first of these new certification requirements and there's got to most likely be an HTI2 in 2024. I mean that's going to be dropped in 2024 for commentary to be implemented 2025. So, as we think about the evolution of these new rules for certification, how do you think that will evolve and what exactly are we starting with and what do you see as being the next steps?

Micky Tripathi: 48:53

Sure, yeah, so HTI1 isn't just about certification but it's got. I mean, certainly certification is a big part of it, because there are some things in there on information blocking which technically isn't about certification. That's a whole different thing which is information blocking, but the things I mean there are many things. It's a 958 page rule, I think. So there's lots of things in it and but you know, things that I would point to as being really significant, I think, are three things. One is the establishment of the USCDI version 3 as the baseline standard for the minimum data set, essentially for the industry, because that includes pretty significant health equity related data elements that weren't a part of the USCDI. That you know, that we inherited coming in and so you know. So that's a pretty big deal and you know the industry has been asking for that, federal agency programs are asking for that, so that's a really important part of it.

Micky Tripathi: 49:48

The second is it's the first, you know, set of regulations that this administration has put into place related to AI and healthcare. There's obviously already different regulatory mechanisms you know that are in place. You know OCR I shouldn't say it's first, I mean OCR has draft rule related to non-discrimination in the use of AI-enabled tools. Fda regulation has been placed for many years. That does, you know, have authority over medical devices that have AI-enabled features in them.

Micky Tripathi: 50:21

But this is a, you know, pretty substantial regulatory step forward, specifically with regard to AI and healthcare and the requirement there is for transparency. It's really to empower clinicians, whether it's physicians in physician offices or in hospitals. It's to empower them so that they have better awareness of the AI-enabled technologies that are embedded in their electronic health record system and to give them some information so that they can make better judgments about whether that particular AI-enabled tool is appropriate for in their particular setting. So it's really not about regulating the AI-enabled tools themselves. We're not assessing those. We're not monitoring those.

Micky Tripathi: 51:04

What we are doing is saying that if you have an AI-enabled tool in your electronic health record system, you, as the EHR, have a responsibility to make available information that will allow the user of your system to judge whether that particular AI-enabled tool makes sense in their environment. And then the third thing that's part of the rule was that the statutory requirement that came from the 21st Century Cures Act, which is a new kind of program called the Insights Program, which requires that electronic health record vendors produce information that will be aggregated and made available publicly. That gives us a sense of where are we with the EHR implementations and interoperability. So how do we think at an industry level, like an industry level dashboard of health information technology adoption and use and again, that was a statutory requirement, so it was required that we put that into place and the first set of measures that we are proposing to be part of that dashboard are part of that HTI one.

John Moore: 52:14

Okay, so I have one final question that that all raised. I had a whole bunch more questions in our discussion guide but due to limited time there's only so much we can cover. But a few weeks back the White House, the Biden-Harris administration, released their SDOH playbook and earlier this year at a congressional briefing, you stated that quote. We are really thinking about health equity as a core design principle, starting with the data itself. You've got to have that data available in order to be able to identify where there might be communities that are getting different types of care. So how much does that tie into this new SDOH playbook initiative and how much is the ONC involved with the development of this playbook? That is supposed to be if they're able to pursue their dream. As it's laid out, it's supposed to be an all-of-government initiative, pulling in data from various disparate sources to better identify what are the social ails that can be traced back to social determinants of health and health resource needs. So can you talk a little bit about ONC's role in moving that forward and scoping that out?

Micky Tripathi: 53:24

Sure, so, yeah, so we were very involved from minute one of the SDOH. It was what's called an IPC, an Inter-HC Policy Committee, that created the SDOH playbook. So it's, you know, ipcs are kind of, you know, sort of started or initiated by the White House, someone in the White House or a group in the White House and, as the name implies, it brings together federal agencies together to work on a particular area. And in this case, sdoh was, you know, was there, there was one for AI and there's, you know, others on the many of them, but this one we were involved in, you know, literally from the very beginning, as they were just forming the IPC. We were directly involved with them and, you know, trying to sort of think about how we think about this from a health and information technology perspective, because, obviously, electronic health records and interoperability, but you, I mean you, can't have a healthcare discussion meaningfully, I would argue, at this point, without talking about the health information technology aspect of it and how that will either enhance or, you know, be a detriment to whatever it is you're trying to accomplish. And then how we can, you know, sort of figure out how to, you know, make up something that's helping to advance. You know, important policy objectives.

Micky Tripathi: 54:38

So when you look at the SDOH playbook, I think you see significant portions that talk about interoperability. It talks about, you know, social and mental health. It talks about the importance of having the USCDI, you know, be a core construct of that. As I mentioned before, you know, having the USCDI version 3 is a really important step forward because that has those health information, that health equity data elements that all of us are looking for to be able to build programs around. First we're going to identify where there are issues and then, second, to be able to have programs, you know, built, leveraging those data elements. And you know, uscdi version 3, assuming that it becomes well, it is actually we've got the final rule out it will now, you know, become the basis for Tefka exchange, for example. We start with USCDI 1 because that's what we have, but that will up to USCDI version 3, which starts to have those data elements that allow us to be able to have that health equity by design kind of construct. That it's starting with the data and then you build up from there.

John Moore: 55:35

Okay, yeah, I mean I would love to talk to you more about the SDOH playbook and how much staying power that has post this administration, because I think that's one of the big unknowns right now. No-transcript. I think that there's a huge need for that across healthcare. But figuring out the kind of economic model for that, While we're still operating under largely fee for service kind of infrastructure, I think that's a huge need for that across healthcare. But figuring out the kind of economic model for that While we're still operating under largely fee for service kind of infrastructure, is something that you and I could probably talk about for days. It's such a big need and such an interesting area. So maybe that's maybe we can have a follow up conversation on that sometime in the future, but for now, thank you so much for joining us today, Mickey, Particularly as we explore the many ways that industry stays in the future, and I think that's a really important part of the process.

John Moore: 56:35

So if any of our listeners want to be more involved with the process of developing new policy, how would you advise they go about making their voices heard? How would they get involved with the government? Yeah, I mean there's a variety of ways, you know. Certainly. We meet with stakeholders all the time, so we're always happy to do that. Our high tech, which is our federal advisers, we're always happy to do that.

Micky Tripathi: 56:54

Our high tech, which is our federal advisers committee, does everything in public, both the full committees as well as the subcommittees, and always at every meeting has an opportunity for public comment. So I think, getting on our website looking up the high tech and there's a number of different work groups there and people are interested in that that's a great opportunity to sort of, you know, just dive in deep on the policy issues that we're contending with and be able to offer the opportunity to provide public comment, all of which is recorded, and you know that we always take into account.

John Moore: 57:30

All right. Well, there you have it, folks. A big thank you for Mickey Tripathi for taking this time. I know that December is always busy for everyone, so I really appreciate you meeting with us to record the session and sharing your expertise with us. Happy holidays and have a great new year.