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One of the things that's really important to know about the USCDI is that it's required in all certified EHR systems. And so that covers 80% of the ambulatory providers and 95% of hospitals across the country. And so we try to be judicious to say, it's in effect, the minimum data set of the healthcare delivery system. So we want to be cautious because it's applies to everyone and we don't want to put additional burden on vendors and providers for a whole bunch of data elements. It's like, well, I never use that. Why am I being forced to think about that.

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Thanks for joining us on This Week Health Keynote. My name is Bill Russell. I'm a former CIO for a 16 hospital system and 📍 creator of This Week Health, a channel dedicated to keeping health IT staff current and engaged. Special thanks to our Keynote show sponsors Sirius Healthcare, VMware, Transcarent, Press Ganey, Semperis and Veritas for choosing to invest in our mission to develop the next generation of health leaders.

All right. Today we are joined by Micky Tripathi National Coordinator for Health IT for the ONC Micky. Welcome back to the show.

Great. Thanks bell. Really delighted to be here.

Well, the last time we talked, you were not in this role but it was soon after that, that you, you stepped into this role. You've been busy. We have a lot to talk about. TEFCA, USDI, electronic, prior authorization, RFI, information blocking, health equities by design. A lot of stuff going on there. Since you made the transition and we haven't talked since then, tell us about your first year in the role. What has it been like?

Yeah, it's been it's, it's been quite a whirlwind as you might appreciate. There are just a few things going on in the country. So far it's just been, it's been a great experience and a ton of stuff to do. So this isn't my first tour in the federal government. I should say. I was I worked for the federal government in the Pentagon in the 1980s. Tells you how roughly how old I am. Then I worked in the air force controllers officer on the your staff, your first Chief of Staff's office and then moved to the secretary of defense's office.

And so in some ways had some of the same experience in terms of now I'm in the secretary of HHS's office, then I was in the secretary of defense's office. And so I sort of came to it with a little bit of an understanding of kind of how those relationships work. Kind of what it feels like to work in the federal government.

But HHS is a very different agency than a than department of defense. So lots and lots of similarities. You've got the the military services, which are kind of like our operating divisions. So they're, we had air force, Navy Marine Corps army. Here we've got CDC, FDA SAMHSA is the operating industry so lot, a lot of similarities, a lot of differences. One thing I'll say at the end is, is just one of the things that I really was, was happy to find that I regained or it brought back all of those same feelings about sort of the privilege of working for the people and on behalf of the people. There really isn't a spree decor, I think, in the federal government to be working on issues that are, that are important to people. And as soon as I started on day one, all of that came rushing back. So that part's been really fun as well.

It's an interesting role. I mean, clearly the federal government is the largest payer, so there's an awful lot of influence that goes with the position. You also have policy. So from that perspective, there's a lot that you can do.

But I remember talking to the surgeon general and he said predominantly his role is a position of, a bully pulpit influence, is how he described it. It wasn't a lot of making people do things. Now do you feel that same way or is there some policy and some leverage that you can pull?

Yeah, no, there certainly is policy and leverage that we pull. I mean the bully pulpit is certainly a big part of the job. I mean, for sure. So I think of it as kind of the spectrum of hard levers to soft levers. And something on the soft levers side is the bully pulpit and that coordination part of being sort of trying to connect dots, trying to encourage people to act in ways that are both in their interests, but also in the public interest. And how do you connect the dots on that? Cause it's not always obvious to people. So I think connecting those dots is an important part of the job. I think what may be different about ONC versus the surgeon general and I can't speak for the urgeons general, I don't know all of the authorities they have, but the ONC we're, we're a regulatory body. I mean, we regulate electronic health records through our certification program. It is a voluntary certification program, but I think as almost all the HR vendors feel compelled to to certify their systems because they're required to have the providers where their customers are required to have those certified systems in order to participate in, in different CMS programs and, and also commercial programs, so know, started to lean on ONC certification, that's know kind of a standard that they want to make sure that the HR systems that that they're working with have in place.

So we have that and then also from 21st century we have the information blocking provisions as they were, which are about the encouragement of of information sharing among providers. That's also a regulatory function that we have. So we have a little bit more of those hard levers then then I think the surgeon general's office may have. So we kind of got the whole spectrum there.

All right. So my gosh, there's so many things to talk about. Let's, let's start with TEFCA. So trusted exchange framework, common agreement, is that close?

Trusted exchange

framework and common agreement. No one sees it. I'll make up that name

Acronym, as I say, acronyms happen. Major movement in January. What do we need to know about TEFCA at this point?

Yeah. So I think the most important thing to know about TEFCA is A, that it's now available for networks to participate in. And then the question is, well, what the heck does that mean? Imagine a world where you think about your cell phone and think about cell phone systems and let's say that AT&T and Verizon and T-Mobile, weren't connected. All of them great nationwide networks, but each of them kind of a private network.

So if I wanted to call you Bill, I would need to know, well, I'm on Verizon. Oh, you're on T Mobile, we can't talk or we can only text, but we can't talk for example. Now with AT&T it's like, well, I can call, but I can't text. That's a little bit of the situation that we have today in the clinical interoperability world with respect to networks. That there are lots of networks out there and the private sector has done a tremendous job, I think moving forward and putting together networks, but because it's the private sector each of them has got its own sort of peculiarities and its own uniqueness.

And so they don't seamlessly connect in the same way that cell phones, for example, or electricity grid across the country. May a lot of people may not know that our electricity grid, isn't a single grid. It's a whole bunch of subsystems that are connected together. And we experience it as a single system, just like we do with cell phones, but it's actually a bunch of sub networks that are connected up.

So what the 21st Century Cures act did is say to ONC create a governance model and a model for connecting up those networks so that we have that same kind of experience as a user. Whether you're a provider or a patient or a public health agency how do we create that backbone infrastructure so that you can connect with anyone regardless of which network they're on.

And you'll experience that as being in the same network and you won't have to worry about what's going on in the back in the backend. So that's really the most important part of that I think. And the analogy, another analogy I would use is think about the way that bank systems work today.

The ATM's, that's where I was going to go is interesting. You use cell phones and not ATM's cause TEFCA would be like that, that common ATM framework that started to come together. At some point, which allowed us to go to any ATM and, and.

Right. You and I are old enough to remember when you have to look at your card and it's like, ah, this is a Cirrus. I'm in a Cirrus network. I have to go find a Cirrus ATM. So my kids, they're kind of like, well, my kids are like, what's an ATM. They're just, they're just, they're just using Venmo. But but yeah, I mean, I think that's the same analogy. But and one of the things that, you know, that. TEFCA is more about the backend structure.

So how do we, how do the banks have a system where I take money out of an ATM with the ATM that's right down the street here, which isn't my bank's ATM, but as soon as I log into my bank's portal, that's up to date. Right. It actually has the transaction there. There is a backend system that makes sure that your information is accurate, reliable, and up-to-date, and that's what we want TEFCA to be able to do for medical records so that when you show up at your provider, there's the backend system that makes sure that to the greatest and possible the medical records that that provider has access to are up-to-date and reliable so that they have the best information available for them.

If people want the details about TEFCA Micky and I had a conversation last year, you can go look at that show. And we went into details of the Sequoia project and their role in it and a bunch of other things. They can really get the deep dive into it at that point, if they want the details.

There's even mpre details now available on the website, because now that we're able to release it. That's all out there now.

📍 📍 We'll get to our show in just a minute. As you've probably heard, we've launched a new show TownHall on our Community channel. This Week Health community. And it airs on Tuesdays and Thursdays. I'll be taking a back seat to some of these people who are on the front lines. TownHall is hosted by an array of talented healthcare leaders who are facing today's challenges head-on. We're going to hear from professionals and their networks on hot button issues, technical deep dives, and the tactical challenges that healthcare faces. We have some great hosts on this. We have Charles Boicey and Angelique Russell, Data Scientist, Craig richard v ille, Lee Milligan, Reid, Stephan, who are all CIOs. We have Jake Lancaster and Brett Oliver who are CMIOs and Matt Sickles, a Cybersecurity first responder. I'd love to have you listen to these episodes. You can subscribe on our Community channel. This Week Health Community, wherever you find and listen to podcasts. Now let's get to the show. 📍 📍

I want to get into the pragmatic. So healthcare providers, what are they going to need to do? Or what should they be doing now in preparation for connecting, participating in the TEFCA framework, or as we said in the analogy, the ATM framework, so that the medical records, as somebody gets a lab drawn over there is it shows up over here instead of the point to point connections that exist. I imagine TEFCA can act as a way to get it from a lot more sources.

Sure. So there's a couple of things. I think for the vast majority of people using certified electronic health record systems or electronic health record systems in general. Right now they probably don't need to do anything. What they need to do is wait for their network which is either CommonWell or the e-health exchange or care quality, which is a different one.

Their network is going to figure it out what their participation is because TEFCA is for the networks to participate in. So if you're a participant in a network, like you're already in the, as a part of that network at some point they will sort of make a plan to connect to the broader TEFCA network. And for you as a provider, you will be asked to sign an additional agreement, or it'll be a rider on the other contract you've already signed. And then after that, your vendor should enable that within the system, within your EHR. So you actually won't really even have to do anything. You'll at some point just experience that wow. I can connect to more people than I was able to before. And that's kind of cool. For those who aren't yet a part of those networks right now, then I think that it's the idea is to either connect with one of those networks. Now, if that was if you, for some reason felt like I wasn't gonna get any value from those networks, it may be that once they sort of join TEFCA that you feel like, oh, that's the point at which it makes sense for me to join that network now because it connects to any other network and I can choose which one makes most sense to me. Because I don't have to worry about, well, who is that particular network connected to because there'll be connected to every other every other network that's participating.

So if you're not a part of the network there's either, if you have the opportunity to join one of those, you may, you may want to wait and see what happens with their TEFCA participation and then join them or to see if there are any new networks that either get formed or are joined and then deciding which ones of those you want to participate in.

If we anticipate there'll be some new ones, I mean, this TEFCA is certainly about connecting the existing networks, but we also expect that it's going to be a motivator for new new networks to form and for really innovative approaches to this.

Is this going to replace the HIE? So if I have a regional HIE, Southern California, we had a regional HIE in Southern California. And it struggled from time to time for funding. And some other things. Is this going to provide the backstop for that? That I was always worried that that thing was not going to be funded and all of a sudden we weren't going to be able to exchange records?

Yeah. So

it's know you raised a couple of issues there and it certainly shouldn't replace HIEs. The idea would be that HIEs can connect to this network and then you're in Southern California now. You're not only connected to the those folks who were in that HIE in Southern California but you're connected to everyone else in the country and that HIE doesn't have to do any more work. At that point they're just connected to everyone else. So conceptually and I think what we've seen in other network industries is that that actually adds value.

People think that, oh, one network conquers another one. Well, what actually happens is that participation rises in both. Because of the network effects that everyone feels like, oh, I'm actually getting great local stuff in my local network that I didn't want to lose by by joining some other bigger thing that maybe didn't provide that.

Now I get all of that through that local network. So actually you see people sort of join participate in. We've seen that in the private sector with different networks to connect care quality and CommonWell, which were seen historically as competitors, it turns out that once they connected at some level participation in both rose. It was a win-win or a positive sum game. It wasn't a negative

sum game.

We're going to get to information blocking, but before I get there talk to me about how TEFCA is going to impact the patient experience.

Yeah. So it should be in a couple ways. One first is the backend experience, which is to say that and that may be an indirect benefit, but you know, the patients only sort of indirectly notice which is to say that they should have the experience that their providers have more access and easier access to their records than they have before. So they're not being asked to lug records from one provider to another, for example, paper records. They're not being asked as many people have to do, which is I've just got imaging done at that hospital down the street, and you're telling me I have to come in in person to pick up a CD rom and bring it to that hospital down the street, that it should take away a whole bunch of that stuff.

And then as I said, that's indirect, right? For a lot of us, we may not actually notice that cos you know these things happen incrementally. Right. And then, so at some point it's like, oh, I didn't have to do that. Great. But that's that's people's expectations. So in some ways they don't celebrate it.

They're like, well, that's what I expected anyway, was that that was going to be happening. So that should be happening in the background. They also will have the opportunity to connect to the network themselves through a vendor. And what that will allow them to do is just like they connect to a patient portal today.

For example, you may log into the patient portal at your provider right now that just gives you the information from that provider. But with the TEFCA network, individual access is a required purpose, meaning that there, there are vendors who could be certified to be on the network and once they're on the network, you could use one of those vendors to basically ask for your records from any provider. Not just the provider that you know, that is connected or is providing you with that portal. So for those patients who choose to do that, it should be easier for them to gather their information, regardless of where which provider they go to.

As we know, like Medicare patients they often see 5, 6, 7, 8 different providers. And so that could be a real convenience.

I wanna move on to U SCDI version three. You added some new data elements, health status, procedure, health insurance, patient demographic, data classes. Some interesting things in that. Is USCDI version three related to TEFCA in any way, just so I don't jump topics here and confuse people.

No, it is a, yeah. So the USCDI itself in general is related in that the requirement for, cause one of the questions that anyone might naturally ask the network is well what information gets shared? Like is there a minimum requirement of what needs to be shared? Is there a maximum, is there a flexibility? So what we said there's a part of TEFCA that the minimum that's required to be. Is is the USCDI version one. So not the version three, but the version one, and the reason we did the version one is because that's, what's required in certified EHR systems is the USDI version one.

And I can describe why version two version three and how those fit into the picture. But we basically said that us CDI version one, that's, that's the minimum expectation that everyone should have about the information that they get. And the reason that we want to do that is we want to be able to say, how do we create a uniform floor across the country?

So that regardless of where you are, you're in Southern California, you're in Nome, Alaska. You're in Athens, Georgia that when you query the network, you should have the same expectation that at least I can get this amount of information. Maybe that's not everything you need. I figure out other ways to get the additional information, but everyone should have that basic service of, I should be able to get this mentally. So that's what the U SCDI version one does. The reason we have version one version two version three is that.

You're adding data elements right?

We're adding

data elements, right? So every, every year, year and a half, we add more data elements and we do it. We try to be very judicious about that. And so we have a very public process where the public industry, federal agencies could submit their their, their suggestions for additional data elements to add. And then what we do is we have a set of criteria, like how mature is that data element. Because people might suggest something that they want that, but it's like, well, there's not a good standard around it.

And so if we try to get people to use it, they're not gonna know what to do with it. Or it's just creating a mess because people are just gonna be putting free text in because there isn't a good standard around it. So we haven't helped solve problems. We've actually contributed to the problem.

And so we go through a thing of maturity and and industry importance because one of the things that's really important to know about the USCDI is that it's required in all certified EHR systems. And so that covers 80% of the ambulatory providers and 95% of hospitals across the country. And so we try to be judicious to say, it's in effect, the minimum data set of the healthcare delivery system. So we want to be cautious because it's applies to everyone and we don't want to put additional burden on vendors and providers for a whole bunch of data elements. It's like, well, I never use that. Why am I being forced to sort of think about that.

So every year we try to go through it methodically, and then we have a law sort of a longer process for saying, all right, how does the next generation like USDCDI version two? Then it goes through a process of voluntary certification for for those vendors.

And those who want to use it, we're able to say, all right well put those into voluntary certification so that people can start to incorporate those if they want. And then if it seems to get a really good uptake and really strong uptake, then we'll take some subset of those and say, all right, now what's a requirement for everyone.

So that's why you see USCDI version one, version two, version three. And we do it as an evolutionary kind of process to allow people to offer what they think is important, but also allow them to incorporate it over time.

People may appreciate this. They may not. But I imagine if you speak at a conference and there's a line of people there. About a third are going to come up to you and say, you're not moving fast enough. About a third are going to walk up to you and say, you're moving way too fast we can't keep up. And so that's why you try to come off as reasonable. It's like, Hey, we're doing this with USCDI version one. But we're still making progress on two three, because we have to do those things in the interest of public health and other things, get that data set together. As we look at these, these specific data elements, health statuses procedures, health insurance, patient, demographic, data classes. Talk about why those specific data elements were added in version three.

Sure. Yeah. And just, just to refine just one last point on just building on what you just said, it's also very iterative, I think. So we work closely with providers and with technology developers and others and when we add something to the list, what that does is it gives impetus to the industry then to say, Oh, okay now we're seeing what the pipeline is. So we're seeing these data elements, like what's in USCDI version two? What's in USDI version three? We have a pretty good sense that those are going to be included and required for certification. So let's get all of the work done to make those as usable and mature as possible.

And I've for 20 years prior to joining the federal government a year ago, I was on the private sector side and you know, I can assure everyone that that's how we responded, like with the Argonaut project and other projects, when we saw what ONC put into next, USCDI sort of a future that, that future USCDI version one and version two, that was when we looked and said, oh, we better get to work on those now.

And we'd better make those more mature. So it is very iterative. We take from industry what we think is going to be right. And then we say, oh, okay, we're going to do this. And then they say, oh, let's make it ready. Let's do everything we can to make.

Is there any chance that industry would get ahead of you and say, Hey these 10 health systems have come together. We've decided that these sets of data elements make sense. And between us, we've sort of codified it and we'd like it to be considered.

Yeah. I mean, I mean, that happens all the time. For sure. There there are different groups, different organizations, either through HL7, the standards organization, or through different of these FHIR accelerators and different other just kind of groupings of providers sometimes in HIE and other places where they do they do that.

And now some of them will just move ahead with what they've created and then hope that it'll get incorporated into the USCDI as well to give sort of added added boosting to it. But at the end of the day, I think one of the challenges for everyone is that our healthcare system is so fr gmented. You can have 10 providers who agree on something, but it's still really hard for them because they're fighting against that. I mean, I don't mean fighting, but you know, their vendor has a national business base. And so their vendors like, well, it's really hard for us to create your standards and your standards and your standards and your standards.

And in health healthcare, because it's so fragmented the role of ONC and CMS ended up playing a lot of that role of just sort of defining, well, here's a floor that we can all agree to and then everyone's like, all right, that's what we can all agree to for sure. Because we all know that we we're going to have to do that.

So again, it's very much an iterative kind of process. So back to your question on the version three here's there's often a as I said, we get a lot of input from industry and providers and to think some of the big ones certainly the insurance information is a whole new category of information that we added in version three that wasn't there before. And that's it the insurance information is just really important. We heard it from providers the importance of being able to have that information as they go from from provider to provider, but also for patients because remember the USCDI, the US core data for interoperability.

Not only is it for interoperability, meaning provider to provider, but it also defines what is required to be made available to patients, for example, in a patient portal or through that FHIR API, that they can use the apple health record or the app of their choice to be able to download information. That if USDA defines what's minimally required to be in that.

And so for patients ,insurance information is just incredibly valuable for them to be able to have that access to the information. And my hope is that where we're able to head with that is I think what would be sort of a huge win for patients and for providers is not having to fill out the clipboard every darn time you'd go to.

If you put health insurance into USDCI a nd I go to a new employer or whatever happens. For me, probably the next step is becoming a Medicare patient, but I give that card one place. Potentially that should propagate across anybody who's participating, right?

Yep. Yep. Yeah. Yeah, no, there's still a bunch to do to make that happen, but the foundation is to say have it represented in a standardized way across all the HR systems. Then you're able to start building building stuff on top of that in different applications and things. So for example, take the smart health card. I don't know, you've got a vaccination. If you did, you might've gotten a vaccination credential, a digital one, you certainly got the CDC white card.

Oh, I was going to say, where's my card, my cards on my desk somewhere it's under papers.

Right. But now it turns out, I mean the federal government just to be clear, the federal government does not endorse the vaccination credential nor do we endorse a particular standard. But it turns out that what the market has done because of the foundation of electronic health records that are out there now because of the requirements that the electronic health records support FHIR and a particular version of FHIR. FHIR R4F APIs. And because of the push from ONC to make patient access a key part of what technology is required to do, to allow patients to have access to their information, bring it into the device of their choice, and then have them be able to do what they want to do with their own, with the information that they have in their hands.

All of those things kind of came together with the vaccination credentials. So that so that the industry itself came together and said, we're, we're going to create a standard that's based on FHIR R4 and that's based on that paradigm of a patient having being empowered to have their own information in their own hands and have that represented in the way that's convenient to them.

So where did that go now? Now 80% of US-based individuals have access to what's called a smart health card. And the smart health card actually has a QR code and I could pull it up. I didn't, I should've pulled it up before, but it's got a QR code that has your vaccination information in it. Imagine now, going back to USCDI verion 3.

What's stopping us from moving forward and saying, well, what if I put your insurance information in that same QR code, for example, and your other patient demographic information so that when you show go to the next hospital, you just scan your QR code and it just picks it up. It says done. No no clipboard required. Now, those are the kinds of things that we're hoping that laying this foundation, the industry can really innovate on top of that and come up with these kinds of solutions.

Yeah. The VCI, when that story came out, I commented on it on the today's show, which is a little 10 minute show I do every morning. And my comment on that was this proves we can do it. When there is a, an agreement we can, we can do the interoperability that we need to do. And this should be like an a case study for, we can grow from here. We can do other things the same way we did this. I'm going to be remiss if I don't keep us moving here.

Information blocking. What stage are we at in the information blocking? I actually, I think you called it information sharing that last time you like corrected me and you said, nah, let's stop talking about it. Is there information blocking? Let's talk about it as information sharing. So where are we at in this?

I still firmly believe that. Unfortunately I wasn't around when they created the loss. So the law actually calls it information blocking and the ONC rule, which I also wasn't around when they wrote the the, the final rule that also calls it information blocking. So I personally feel like we should be talking about information sharing, but it does say information blocking.

So I always try to remind people that when I say information sharing, that's what I'm talking about. So people aren't confused. So where are we? The rule went into effect on April 5th, 2021. So it had been delayed a number of times the 21st century cures act was passed. And remember it was passed in December, 2016.

And so when, when I took this job in January of 2020, they've been for years and over four years or, yeah. When I took in 20, 21, sorry. It had been, it had been over four years since passage of law and none of the key elements of 21st century cures act to acknowledge the fact.

So we came in and just. Yeah, we've got to get this moving and that is the law and the, and it's going to help solve some of the problems that we have and interoperability, and that, that were preventing us from having a kind of pandemic response that we wanted. So anyway, so April 5th, 2021, it went into effect for all of the actors that are named in the role.

So that's providers. Certified health IT developers. So the EHR vendors that we all know as well as as well as others who are certified. And then health information networks and health information exchanges. Those are the three actors that are covered by the information by the information blocking regulations.

So that went into effect on April 5th, 2020. The law's really peculiar in some ways in that what it did is it gave the secretary of health and human services who delegated to ONC to create the policies, to define what is information blocking. How would you define that from a policy perspective, but enforcement is with the office of the inspector general. So we work in partnership with them, but we don't do any of the investigation in the enforcement. We basically say here's the policy. And that's what went into effect on April 5th, you're required to comply with this policy and we set up a complaint portal as the law specified.

So people can come in, they can file a complaint on the ONC website. But that gets passed over to the office of inspector general. And they're the ones who do an investigation. And any determination that someone might be in violation? The reason I mentioned that though, cause you asked where we are on this.

ONC on April 5th said this goes into effect. But OIG has to finalize their rule for how does enforcement happen. And that hasn't been finalized yet. The calendar that they published publicly said that they are going to make their final rule available in March of this year. Now that's not binding so we don't have any inside information on whether that, whether they're gonna hit that date or not, but that's that is what they've publicly made available. So once that comes out, then you have the OIG saying, and here is how enforcement is going to happen of the information blocking regulation.

I have two follow ons. One is, did you mention insurance carriers? Don't insurance carriers fall into this as well?

They do not. So insurance carriers as insurance carriers do not. The law did not name them as actors. Now I will say there is a caveat that an insurance carrier, as we know in this world of a lot of vertical and horizontal sort of consolidation. There are a lot of health insurers who are also providers. They've bought a lot of provider practice for example. And-or they also operate what would definitely be called health information networks. So purely as being a payer, they may not come under information blocking, but to the extent that they're a provider than they would, or to the extent that their health information network, when they would.

This was a heavy lift. There was an awful lot of pushback on this. Right. We had some, some big players. I'm not even sure the American hospital association didn't push back. Some of the large EHR providers back. This was not a simple, simple thing to sort of get the coalition to form around this.

This was a big lift, but the good news is bipartisan, I remember the vote in the Senate was like 93 to 7 or something like that. It was, you may know the exact numbers, but it was overwhelmingly for the 21st century cures act. They're saying, look, this isn't the best interest of patients across this entire country.

And very few people disagreed with it. And if they disagreed with it, they didn't disagree with the core elements they had. Like some sticking point was the reason they didn't vote for. I had in my mind, like the last piece of legislation, I can remember being this bi-partisan. So everybody is saying, look, it it's time for this.

But then when it came down to the brass tax, actually writing out what this policy means and whatnot, that's a hard process, isn't it? I mean, you have to take a lot of feedback and there was a lot of back and forth on it. And that wasn't necessarily you, that was pre.

I wasn't in the job then. They published the final rule before the change in administration. But yeah, there was certainly, it's, it's very complex. So it's really, really complex. And there are certainly a lot of different sort of views and a lot of different interests that, that weighed in pretty heavily, I think in that whole process of getting the public feedback on the draft rule and then the final rule and all of that going on so.

Do we anticipate this will change much? I mean, will, will there continue to be feedback and will this continue to morph over time?

Yeah, so a couple of things, one is is that we are in an ongoing process of We take questions we interact with, and we do a ton of outreach.

And for any of your listeners who who want to interact with us directly and have us come and speak at events, or you want, you want to talk to someone about it, please contact us. We are more than delighted to do that. And we do that every single week and we've got clinical team, we've got a policy team and we're always doing that condom outreach.

We also take all sorts of feedback and input, and then we respond with FAQ. And like information sheets and all of that. So you go to our website, you'll see that we keep adding FAQ's and we also add information sheets when we get a whole bunch of questions in a particular area, it's like, oh we thought we clearly communicated, but communication is only in the eye of the receiver.

Right. So they're not hearing it, we clearly have not set it right. So we're going to create an information sheet that tries to do that. So there's a lot of I don't know if it's really morphing so much as it is to say sometimes no rule is going to cover, especially in healthcare where it's so fragmented and so local, it's never going to cover every particular circumstance.

And so that's where we can help to provide some clarification to say, here's what the rule says. And hopefully that helps people. And that's that's an ongoing thing. And I always consider that that's not a, that's not a bug of the, of our system. I think that's a feature of our system. You define the big policy, but everyone keeps adjusting, but we all need to keep adjusting to make it work.

I'm going to ask you about early winds, but I do want to point people to the website again, because it was interesting. When I was reading about USCDI version three, I went to your website, great resources, phenomenal resources.

And then I started reading the comments below. The comments below are an education in and of themselves have really smart people thought out laying these things out in terms of the comments. And I learned a ton just reading through those comments. So again, great resource.

Yeah yeah these are not, I think one important thing for everyone to realize is these are not, ONC is not sort of Moses delivering the tablets down forever based on the deep wisdom that we have. This is like the industry and really smart, engaged people who are experts and have experience and have a tremendous. At this who are providing us with this information, and then we're able to sort of take all of those things, try to process and say here is the consent to the greatest extent of what we see as the consensus view of how to move this and move this forward with the best possible information that everyone's been able to provide to us.

Do we have some early wins with regard to information, sharing information, blocking?

I guess a couple of things. One is it's too early to tell. Enforcement hasn't kicked in and you've got all those things. I would say one win is that it's not enforced. It took over four years, but it's now actually enforced. And I think to the extent that there was a lot of discussion on it, we get a ton of questions. To me, I think that that the quick way is that it's now on people's minds. And people are starting to think, how does this, how is this different than what I do today?

And whether they take those actions is going to be a part of what we see how that unfolds. But in my mind, the reason I always tried to emphasize that this is information sharing. The reason I didn't like information blocking as a characterization and and I've worked for the last 20 years deeply with the provider community. Both my parents are providers, my daughter's a provider, so I just didn't like the framing of information blocking as being that the parties are guilty until proven innocent. It has the suggestion that everyone has got their chief information blocking officer who was erecting all of those interferences.

And in my experience, it's really more a question of priority. It's that organizations have 10 million things in healthcare delivery, on their priority list. And it's really hard for them to work their way through them. They don't have the resources to do them. And what this is saying is what the Congress has spoken and the spoken very loud voice, as you said, and that means you need to move this up your priority list.

You just need to move it up the priority list and make it a priority, and don't keep kicking it down to, yeah, we'll get to that one next year. We'll get to that one next year. And of course, like, like we all know anything. Below number 10 of your priority list you just never get there so this that's what this is saying and I think the fact that it started that conversation with people's heads, that, that to me is a quick and really when.

Yeah, I mean, what you just described when people ask me about healthcare, it's like, why can't I do this? Why can't I do this? In my experience in healthcare at this point, I hear people knock meaningful use. We didn't do this right. We didn't do this right. And it's easy to sit back and say why did the Buccaneers lose over the weekend? But at the end of the day, I would estimate about half of America would still be on paper records if it weren't for meaningful use. If we hadn't done something to move it up, the priority list, it would've just kept being, Hey, we're in the middle of pandemic, we can't we can't do this. We're in the middle of this. We can't do this. And could you imagine going through this pandemic with a majority of the American medical establishment being on electronic medical records.

I can't, I cannot impossible. I totally agree. I mean, I think that that was just a huge achievement that hopefully as we look back, we'll see that that was a mammoth achievement and overall very successful, which is to take arguably the most complex part of our economy. And in relatively short period of time. I mean, 10 years for the most complex part of our economy and very, very fragmented, flip it from being almost very little penetration of electronic health records. So the point that 90% of them over 95% of hospitals and of 90% of ambulatory providers have really sophisticated health it systems in their offices.

And I know people may complain or not like their EHR system for this or that and the other. But I think most people would agree that a certified EHR system is a pretty sophisticated piece of technology. And I think that happened in a relatively short period of time. And now we've got that foundation, so we can say now, what do we want to do with it?

Because that's the thing, that's why I'm so excited about being here now is it feels like we've laid that foundation. We didn't do that for better billing or just to get rid of file cabinets. Right. We did it for all the things that we can now sort of say, all right, what are we going to build on top of this foundation that we have.

Yeah. And that gets to our last two topics here. The office sent out an RFI for electronic prior authorizations. What, what's the driver for this? And what's the main objective of this RFI?

Yeah, there's, there's a couple of things. ONC has done work with our partners in CMS on what are things that, that provider considered to be burdensome. In general from a process in the EHR perspective. And I think certainly one of the things that, you know, that I think we've seen with electronic health records is there is a concern that that you hear among providers of out too many clicks and don't like the HR and one of the things that I think that is certainly true. Once you look at that, is that so much of what provider may feel as a burden is actually not the EHR. It's all the things that are being shoved through the EHR, because that's seen as a vehicle for, oh, now we can do this. So now we're going to have these, these additional payer requirements, for example, or additional reporting requirements, for example, that it's like, well, that wasn't about the EHR that was about people trying to cram more and more things into it. And in a way, it just sort of magnified some of the some of the things that are pain points of our healthcare system. It's not about the EHR, it's about the healthcare system that's behind it. And often we can't just tech our way out of that.

Sort of figure out how you can do that better. So prior auth has just been a huge pain point. And we would see did some work early in couple of years ago, but had a big burden reduction report that pointed it out that this is a big issue. We last year our advisory committee had the intersection of clinical and administrative data iCAD report, which also pointed to prior auth as being one of the top pain points. And one of the areas that if you we could tackle it using electronic health records systems, that would be a huge win that's what's preferred providers. It's a burden on providers who have to figure out the documentation and that creates payment delays. They spend inordinate amounts of time trying to figure out what this payer or that payer, that payer do I do on the website with them and a phone call with them and and all of that. But it's also a huge thing for patients. We're sitting there waiting, not knowing what's going on.

Why can't I get this this particular service? What am I waiting for? Where is it? There's this basic customer service. And I don't understand the providers like, well, I submit it to the payer. There's like, well, we don't know where it is. Right. And you've got all those things going on.

With all of that mind we said let's just put forward and also CMS, as you may recall, put out in December of 2020. So just before the administration changeover, they put out a draft rule which had a specification for electronic prior authorization. And and like every rule that gets put in just before the change of administration that sort of got paused and now CMS has thinking about what they want to do with that. But one of the things, they got a lot of feedback on that draft rule. And as we looked at that, and we took in sort of the input that we got from the reports we said, well, regardless of what happens to that rule, it's probably worth our reaching out to the industry. W are there electronic ways that we can think about this that makes sense to include in certification and certified EHR systems because EHR vendors have certainly been pursuing different solutions with different payers, have different provider organizations have been pursuing different things.

And we sort of feel like the industry has matured. We've got FHIR now sort of available and, rapid penetration of FHIR. It's not as the time for us to reach out to industry providers and technology developers and say, what does. Are there things that we could put into certification of EHR systems that would help us all move forward in this critical area again, regardless of what happens with the CMS.

I know a lot of doctors are applauding at any progress you can make. They're going to be applauding that's and patients don't know that he should be applauding, but they, they, they would be if they understood the complexities and the challenges that exists in this. I do want to get to health equity. Health equities was a huge theme at the JP Morgan healthcare conference with many of the CEOs talking about their work in this specific area. As I was reading the USCDI framework the version three, it's obvious that this has been influenced by this critical objective as well. What exactly is health equity by design and what are you trying to do there?

Yeah, so, well, the first thing we're doing with the first thing we're trying to do is trying to get a really operational definition of what health equity by design this. So we've laid it out almost as sort of a challenge to us in the industry to say there is a core construct. That that's very familiar I think in business process design, that's both software design of you know saying that things that are so important and fundamental should be a part of the first principle of the way you designed a system. And so we have security by design privacy by design. Safety by design. And so we think that health equity ought to have that same sort of consideration as well. That when you think of your initial design of a system, you should have health equity in mind and equity considerations in mind as you develop that system so that you're not trying to. Patch something together after a bolt, something on after to rectify things that you know, that frankly you should have thought of if you've made it a priority in your thinking to begin with.

So that's the first it's just fundamental principle. And then how you operationalize that is much harder. So the way we've sort of thought about that is first, how do we think about data? And then how do we think about what might be technical capabilities in with respect to kind of functions of the HR systems and, and associated workflows.

So looking first at the data, for example, as you pointed out, we did include in the U CDI, this is the USCDI version two, where we included it, which was released last summer that the first us, the draft of the USCDI version two, which came out just prior to the administration change over didn't have any social determinants of health data elements required. And so we took that. We took the industry feedback, it's a administration priority. It's an ONC priority. It's an HHS priority. It's a Micky Tripathi priority. And we looked at that and we said, we are going to add social determines of health categories in there. So we added four social determinants of health, data elements into the USCDI version two, as well as the inclusion of SOGI, sexual orientation, gender identify data elements. And we already had added race, ethnicity language in previous versions. So that was already there. So that gives us know sort of a good, full set of social determine and health equity related data requirements that EHR vendors are required to support and make available as a part of as a part of their interoperability.

So that's just a core construct that you feel like that's foundational. If we can't identify who individuals are then we don't have the ability to do the kinds of sort of understanding of, are there differences in the quality of care they're getting? Are there differences in their, in their access to care, let alone being able to act on those.

So that's a whole effort that that's already underway. As I said, USCDI version two, with those elements got released. Now the industry is working to mature those standards, and we're hoping that. It means that by the summer of this year, they are at a degree of maturity through the standard development process that they can actually be included in both government payment programs, as well as commercial payment programs and other kinds of programs.

The second part of this, how do you have functions the EHR functions that can, that can help to sort of take advantage, let's say of that data, that's there to be able to do things that help to mitigate health equities before before those equities turned into disparate outcomes.

So the data itself, well, that just helps you identify gives you a more holistic view of the individual, arguably, but it doesn't help you to mitigate or intervene prior to these these issues that made the equity related, turning into bigger issues from a healthcare perspective.

So that second part let me give a specific example of what we're doing there. In August we awarded to the university of Texas at Austin, an innovation grant for them to look at how to electronically refer a patient s to social determinants of health driven kinds of social services in the same way that they can use their EHR to refer someone to a cardiologist, for example.

So how do I refer someone to housing assistance in an electronic way? How do I refer someone to legal assistance electronically, for example, in the same way that I can easily refer them to a cardiologist just for, because for many individuals that might actually be the next best thing you could do. Get them into more stable housing and that might improve their health prospects a lot more than then going to the cardiologist, for example.

So that's those are the kinds of things that when I, when I speak of intervention and we're starting to look at and say, how do we build those into interoperability? The last thing I'll just point to, and I'll just touch on. Is is algorithms. We're starting to take a really good, hard look at that as well, because as we know, we've got more and more algorithms.

I mean, they're all over the place, right? Every time you and I get onto a computer pick up our phone, there are algorithms going on in the background, doing all sorts of things. And in healthcare one of the challenges I think is that that every algorithm is biased by definition. It's it was created based on they set up data and that data has limitations and the algorithm itself might have algorithm, might have biases of just baked into the the different methods that it uses to draw the results that it draws. How do we make that more explicit? So that for those who are taking an algorithm, they are sensitive to the fact that this may not apply to this particular population you train that algorithm at Mayo clinic in Rochester, Minnesota. That may not apply at that hospital in in San Juan, Puerto Rico. And just probably think hard about that before you just blindly applied that algorithm and that in that particular setting. So how do we think about that as well?

I worked for st Joe's in orange county. And we had a groups of people that focused in on health equities, and every time they came to me with one of the challenges they wanted to solve, it was such a nknotty problem. It wasn't like, oh, well just take the eraser and do this, or take the pencil and do that. It was oh, gosh, we've got to get information from, these third parties. We've got to bring it in. We've got to normalize that data. We've got to figure out new outreach mechanisms. Cause some of these people don't have phones. We've got to create relationships. I mean, they were naughty, difficult, challenging problems to solve.

And I guess starting with the definition that everyone, it's a basic right, that everyone should have access to a certain level of healthcare. Right. Everyone should, that should be a basic right. Everyone should have access to healthcare. And I'm not sure we even have agreement on what that level of healthcare is. Right? When you said, Hey, we're starting on defining it I think some people might hear that and go really. That's where we're starting, but it's not as easy as it might sound. These are really challenging problems. Plus we're only talking about healthcare at this point. We're not talking about health. And health is so many other if you tell me, Hey, people, aren't healthy. I'd rather have what they're buying and putting in their body. That data would tell me more about their health than probably their healthcare record, right?

Yep. No, I totally agree with you. I mean, we know that from a lot of research that what is it something like 80% our health is actually determined by environmental and social factors. That's certainly the case and knowing more about that. And I think going back to the the thing of we certainly can define the administration then without the heart health and human services. Health equity we have defined. Social determinants of health we have defined. The piece that I was speaking to is what is health equity by design and designing ways to help IT. Health IT only plays a small role in this. Right. But how can it help to improve the situation? I think that's that's sort of the important thing for us.

In the last minute, cause we've gone up to the last minute here. How can people participate in this work? If somebody is listening to this going, Hey, Ihave a heart for that. That, that really resonates with me. How can they participate?

Contact us first and foremost. Feel free to contact us where our information is available on the website. My email micky.tripathi@hss.gov. I'm happy to direct you to the right people at at ONC. We are very open and accessible. I'm very open and accessible. I'm always delighted to hear from people and particularly to plug them in when they have energy and engagement around that, around any of the issues that we are involved in.

And if people are wondering, I sent an email to that email address and you responded to me, that's how you are on the show. So you are reading that inbox. It's not a fake. That's fantastic. Micky, thank you again for coming on the show and sharing all of this with the community. Really appreciate it.

Thanks so much, Bill really enjoyed it.

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