The Pharmacist as Changemaker with ONC’s Tricia Lee Rolle

Melanie Marcus: Today's guest is Tricia Lee Rolle, Senior Advisor for the Office of the National Coordinator for Health IT, or ONC for short. Tricia Lee is a pharmacist who has spent her career dedicated to promoting the safe use of health information technology in the private sector and in the federal government.

In today's episode, we'll talk with Tricia Lee about what exactly the safe use of health IT looks like. We'll talk with her about how we empower care providers, including pharmacists, with the tools they need to improve patient care. And we'll talk about her love for bunnies. Yes, bunny rabbits. They factored into her decision to pursue a career in pharmacy.

Welcome to the show, Tricia Lee.

Tricia Lee Rolle: Thank you so much. I'm excited to be here.

Marcus: You have had a very interesting career path, starting as a pharmacist and now playing a major role at the federal level and influencing the role of the pharmacist and the use of “safe IT.” I want to dig in on all of that, including your work with the Office of the National Coordinator and your role in the Program Management Office of the Health and Human Services AI Task Force. But first, let's get started where you started. Can you tell us a little bit about yourself and your background?

Rolle: So I am from Queens, New York City. Obviously, there's a lot going on there. I like to say that growing up in New York City prepares you for so much. You see so many things. It prepares you for whatever comes your way in federal government. You're able to observe everything while minding your business at the same time. And I guess in many ways that's a lot of what we do. We observe what's happening in healthcare, and then we learn how to stay in our lane and regulate what we need to regulate, and let the market take everything else where it needs to go. So, I definitely attribute a lot of things to just, you know, being a girl from Queens.

Marcus: What point did you decide to work in healthcare?

Rolle: It's interesting—I wanted to make drugs when I was little. Yeah, I thought I wanted to be a botanist. I thought that's what they did. “Oh, you can take a plant and make some drugs.” Then I learned that pharmaceutical sciences was really where a lot of that happened. So I was a farm science major in college. Spent summers in the lab. There was one summer where it came time to harvest some organs from some little bunnies. And I was like, “What are we going to harvest?” So, totally into bench science. Totally fine with all of that. But for me personally, I realized, you know, I like bunnies too much. This isn't for me. So my mentor at the time was like, “Do pharmacy. It's a broad career. You can still do research if you want. There's so many avenues.” And so I kind of made the switch from pharmaceutical sciences over to pharmacy. And that's how I got on the pharmacy path.

Marcus: Then you earned your Pharm.D. And what prompted you to go on to a master's and then ultimately a Ph.D. in pharmaceutical systems and policy?

Rolle: Yeah, that's just the nerd in me. I had a class, and we talked a bit about pharmacoeconomics, and I was like, “Oh, what is this?” And the whole area of health services research opened up to me and I was like, “You know what? Yeah, let's go. Let's go explore this some more.” And so, I enrolled in a master's and Ph.D. program and that was it.

Marcus: You actually did serve as a pharmacist in an inpatient setting, right?

Rolle: Yes, so I was an inpatient pharmacist at WVUH Ruby Memorial Hospital in Morgantown, West Virginia. And that was a great experience because everyone did everything. And by that I mean every competent pharmacist was working on everything. Whether it was rounds, whether it was helping with chemo, whether it was doing things and making clinical interventions, it was a good time to really practice at the top of our license. And so I got to see a lot of things. And I think what takes a lot of the angst out of my day-to-day job right now is that there's no imminent death coming to any one individual at HHS. So that takes the pressure off. You know, there's no patients coding. But I think what is really fulfilling about being in government is that you realize that what you're doing is really affecting not just one or a few or a handful of patient lives, but we're really doing it in mass and at scale. And I think that's rewarding and fulfilling in many ways.

Marcus: So you had the experience on the inpatient side of really being able to practice at the top of your license and now you’re looking at the whole industry across the US from the federal seat that you hold and how you can influence practice.

Rolle: Yeah. What's interesting is at the time we were using whatever system we were using there. I had no clue about the whole face of health IT. At the time when I was in a pharmacy school, it was not a part of our curriculum. And I'm just using this system and doing whatever and trying to navigate through the tabs and putting in tickets and just like, “OK, well, someone's going to fix it or make it better.” And it wasn't until coming out and discovering ONC that I was like, “Oh.”

Marcus: What is it about the ONC that draws you in?

Rolle: So ONC, it's a really cool place. We were a little staffing division of the Office of the Secretary. So we're not a big division like, you know, FDA, CDC or CMS. We're a little smaller, a little nimbler. And because we're young, I think we've developed a culture of “just get stuff done.” We have really smart folks there, really great people. And in particular, I'll just shout out my boss, Steve Posnack, Deputy National Coordinator. He reached out and said he was hiring up his team. And I'm like, “Of course! Of course I'll come work for you.” So, interesting fun fact about ONC. At the end of April we turned 20 years old. ONC was created by executive order in 2004. And that's exactly how long Steve Posnack has been at ONC.

Marcus: The safe use and adoption of health IT has become a hallmark of your career. Can you explain what you mean by the safe use of health IT for our listeners and why that's important?

Rolle: Two examples that I think about. From the provider and clinician perspective one of the worst things that can happen is trusting false information, or having information presented to you that you just can't rely on. I think about an experience that we were made aware of, where a surgical team performed a surgery on the wrong vertebra of a young woman. Let's say L1 instead of L2 or something like that, right? And there was an error in the chart that got perpetuated, and that was troubling because that's one of the worst things that you can imagine happening as a clinician. That the information you have is not something you can really act upon.

From the patient perspective, I recall a time visiting a provider and then on check-in I was asked if I had a certain drug allergy. And I said, “No, I've never taken this drug before. I don't have an allergy to this medication.” At which point I realize, well, if you've placed this in my chart, that means that there is some person walking out who does not have this serious allergy to a medication recorded in their chart. That was scary as a patient. Wow, you know, it's in my chart, which means it's not in somebody else's.

But I am encouraged because, as we keep using these tools, we keep finding ways to get better at it and to minimize some of those risks where there's human error. Because that's the whole point of tech in the first place. In our USCDI, we have now included a data class for provenance. And that's super important when you think about the clinician who's trying to figure out, “Can I trust this information in front of me?” Or, “If I need to go back and verify information, I know where to go. I know how it got in my record.”

Marcus: So if it's all working well, how would that situation you talked about—with the operation on the wrong vertebra—have changed?

Rolle: I think if it's all working well at the point that it's identified and corrected, there aren't other places where the same inaccuracy persists. And so I think that's a part of what it means to have safe use. And I think it’s also a real example of how it can look and how it can affect clinicians and patients as well.

Marcus: You've written about accelerating adoption of digital therapies. We talk a lot about adoption of technology here at Surescripts because without adoption, you don't get any of the benefits of the technologies that are deployed. You’ve cited federal oversight, value-based care and the increasing consumerism among patients in healthcare as drivers for adoption. If you think about the role of clinical pharmacists, they work to optimize medication management and patient care—what are the drivers for adoption there?

Rolle: One of the big challenges that we have for tech as a whole is the access issue, right? That we still have pockets in this country where, whether it's broadband or Wi-Fi or whatever it is, that there's just not the speed or bandwidth to have great digital experiences in your home or on the go. And that's going to be a challenge because we obviously don't want to create or perpetuate disparities. So I think that's one thing to note there.

Thinking about clinical pharmacy and what the drivers are, I want to say access again. One of the things that we saw during the global COVID pandemic was that there was this intense strain on primary care. And the ability to contact your physician, make an appointment, get into the office, have enough distancing—you know, all of the things that made it difficult to receive care—highlighted the ease of access and accessibility of community-based pharmacists. And I think that was recognized on the federal level with the FDA's emergency use authorization for certain COVID treatments that allowed pharmacists to take a really active role in prescribing those different therapies with some different requirements. And so I think there was a broad recognition or acknowledgment that we have issues as far as healthcare system capacity and strain during these times of emergency. And what can we do and who can we leverage and utilize to help fill some of those needs?

Marcus: So, in general is there something else we’re missing, other than at the state level, to accelerate this adoption of the real role the pharmacists could play in healthcare?

Rolle: One of the things that I'll say is that we are so thrilled about TEFCA. And we are excited about all the possibilities and a future where information is flowing very easily and freely and you on-board once, and you sign maybe one or a few data use agreements or whatever it is. And at that point, information is moving to network participants in accordance with the terms agreed upon. I think there's a lot of promise there to accelerate the information that's needed to support clinical services.

For example, with the emergency use authorization, the provision to prescribe and start those COVID therapies required being able to look at a patient's medical history, have access to it. And obviously to do that, you need to have some data flow or some data feed. And so, thinking about how we can accelerate the provision of clinical services, I would say it's being able to make the most out of where the data is and how we can get it out quickly and get it into the hands of those who need it to make their decisions.

Marcus: That's a great example. For our audience, TEFCA is the Trusted Exchange Framework and Common Agreement, and that is the future of healthcare clinical data interoperability or clinical data exchange.

Let's talk about the ONC’s Pharmacy Interoperability and Emerging Therapeutics Task Force. It's a task force that you yourself introduced in 2023 and did a ton of work in this space. So, what was it like? And what were some of the things that this task force came out with that impact pharmacy?

Rolle: It was the largest task force, I believe, in history. So we had 20—that’s a huge task force—20 members. And so, there was a lot of interest in it. So, 34 recommendations came out of the work of this task force. 34 recommendations to ONC on how to improve interoperability across pharmacy constituents. And the primary goals of the task force were to look at what's needed to improve interoperability across all constituents. So it's not just pharmacies or pharmacists, it's everyone from the PBM to the payer to the switch to an intermediary to the clinicians and end users that are engaged in patient care and the consumers themselves.

We looked at public health needs. How can we do more to ensure that pharmacists are able to be activated when needed in public health emergencies and fill the needs that we know exist in primary care? Of course, you know, within scope of practice.

We also looked at emerging therapies such as what's going on with gene therapies. What's happening with specialty medication as a whole? What's going on in digital therapeutics? And we talked about digital virtual care, virtual care providers and this trend that we're seeing now where folks are not going to the usual office-based practices to seek care or medications. They might go online or use a smart app. And so, what does that mean for all of us? We talked about things like that. And it was just—it was a lot!

Marcus: If you had to take those 34 and put them into some top categories, what would you say?

Rolle: I think some of the top categories that came out of those recommendations were those that address public health and patient safety needs, and those that address the bidirectional exchange of information between different providers, between the pharmacist and the physician. And those three were things that really stood out to me.

Marcus: Let's turn straight to the topic of the moment: AI. You've joined the AI task force that's part of HHS. And you're focusing on responsible use in AI and healthcare. Can you describe your role in this task force?

Rolle: Sure. So, there's an executive order that came out at the end of October, and that executive order has required a host of things across government, not just HHS, to promote ethical, responsible use of AI. And so as part of that, HHS has set up an AI task force that's being co-chaired by one of our deputy secretary counselors and the National Coordinator, Micky Tripathi. I'm involved in the program management office, helping to support a host of coordination activities across HHS to really make it happen. But also, we are working on an entire AI strategy for the whole department that will involve every corner of the department coming together to define what that looks like. And so I think that's a big undertaking. And a lot of heavy lifting across all the operating and staff divisions. And that's being coordinated out of the program management office.

Marcus: Well, that's exciting. And that is a huge job. So what does ethical and responsible use of AI mean in healthcare?

Rolle: One of the different components that I think are really important here is that we have our FAVES principles. And this is something that ONC has put out. And you've seen it be adopted across different parts of government. FAVES stands for: Is it fair? Is it appropriate? Is there validity? Is it effective and ethical? And then, is it safe? I think a lot of those components go into that. But also, we are interested in understanding how we can harness the benefits of AI in a way that works for all of us.

Marcus: Do you see AI being used effectively first in the operational side?

Rolle: I know the perspective that ONC has taken on this is that the tools are being used. It’s out there. And the step that we've taken first in our HTI-1 final rule has been: What can we do to create more transparency for end users so that they can actually trust the results or the recommendations that come to them? And so, the harder it is as a clinician to have information that you can't or shouldn't be trusting, the HTI-1 final rule has outlined provisions around what types of information should be made available on the source attributes that contribute to an algorithm. We've described it as a nutrition label, if you would. It's about maybe 20 or so different types of categories of information about things like the demographic information of the population of study or information on the training sets that have been used to help build the model and train along the way. Information about the governance and versioning that might be of importance as well.

And so obviously, if I am a clinician, I would like to know if there's an algorithm that was just trained on a host of brown-eyed patients. If I happen to see a bunch of blue-eyed patients, that might be important to me in how I interpret or rely upon the outputs of a decision support intervention tool that I'm using. We know there's a lot to learn as the tools continue to be deployed and continue to be used. But as a baseline, how can we make a similar set of information available so that you can decide as a clinician, “Is this a tool that is going to work for my population? And is this a tool I want to keep using based on some of this versioning information or some of this governance information that's now been made available to me?”

Marcus: So what's next on the horizon for you in terms of what you'd like to accomplish?

Rolle: Oh boy. Just thinking about AI in general. Across the board there is a mad dash for talent and individuals. I think the federal government is going to be competing with industry to get great talent and to train and recruit. One of the things that is a concern for me is, will we do a good enough job to convince super smart people—the data scientists out there—to come and give some time and service to the government? That this is a place where your AI career can grow, not stall. There is a lot of cool stuff that's happening at HHS.

Marcus: That leads me to another question. As you talk about bringing people into government around things like AI, I also think about all the work that you've done. You said it yourself, like you had one of the biggest task forces ever with the Pharmacy Interoperability and Emerging Therapeutics Task Force. Can you help our listeners understand what it takes to get stakeholders aligned in this field?

Rolle: I think that you just got to be willing to listen. Everyone has a perspective or an interest or some equity at stake. And I think it's also important to acknowledge those. But also realize at the end of the day, we are still working towards the same goal. And I think where you can find that common ground or those common interests, it'll be a lot easier to build around that and move forward. I think that it's OK. We need unity but not uniformity. We're not going to have uniformity in healthcare because we're all doing different things. But we can at least be united on a specific goal or a specific endeavor or a specific purpose. And I think that's OK. Let's identify what we can be united on and let the rest be what it is.

Marcus: This year our key question is about helping healthcare heal itself. So we're thinking about healthcare as being broken in many places in the United States, and that ultimately, the healthcare marketplace itself does actually know and have the power to heal itself. And so I ask you, first of all, what's your diagnosis? What's wrong with healthcare today?

Rolle: Let me answer the question by saying what I think is good. And then kind of coming back to what I think could use some more work. One of the things that I think is just amazing, not just about healthcare, but really all of life sciences and biotech as a whole and just being alive in 2024, is that we are seeing so much innovation when it comes to what's coming out of life science companies. CAR T therapies, where you can literally cure disease and make real, life-altering changes in someone and tapping the genome. I think that is just—wow, that's amazing. And we're alive to witness it. So there's that.

I'll use another, I guess more popular example: GLP-1 drugs. It's in the news every day, people are looking for their shots. And we have a class of medications that was helpful for diabetes and we learned along the way that there are also benefits for those who want to lose weight. And so we've seen that take off. Groundbreaking innovation and discovery. And it's amazing to see that. I think the challenge, or I guess what might be wrong here is, we've said it before, right? It's access. Access and affordability plague us. While I pray that nobody needs to have some gene-altering therapy—God forbid you do—how easy or difficult would it be to get that? And that to me is an issue or a challenge that, you know, we’ve had these great therapies available and they're continuing to come out at a rapid pace. But we still have trouble being able to get those therapies and treatments to the ones who need it and can benefit from that.

Marcus: It’s so clear that there's really some amazing things happening in healthcare, and it does present us all with challenges for being able to access it, afford it, know it's the right time, manage it once you're on those therapies, and stay on the therapies so that the impact continues and so forth. So how would you heal healthcare?

Rolle: Just thinking about those two issues of access and affordability. I know a lot of folks, they want to take the lead of government. We're going to watch CMS. We're going to watch to see what Medicare is going to cover. But I do think that's not the full answer. I think there's a lot of innovation when it comes to access and affordability that we can squeeze out of the commercial market space as well. And as far as the squeeze, I think that is value-based care. I think innovation comes with a price tag. But I think if we really can focus on developing great value-based care models, that we'll be able to find the savings and realize the value needed to get these meds where they can do the most benefit.

Having strong data and strong connections is a part of it. We've got great interoperability right now with the providers, and we're doing better with the payers as well. But if we think about some of these medications, it's going to involve interoperability with life science as well. Everybody's got to be involved in this if we're going to be able to track the value across the actual product and the end outcomes. And so, I think that there's more that can be done to really flesh out these value-based care models. And there's certainly a role that the data and interoperability can play to help support accessing the pieces of information we need to establish and confirm the value that we know is there.

Marcus: I've been tracking value-based reimbursement for the last 12 to 15 years. And it's taking a long time. But I agree with you. Ultimately, it's probably taking a long time because the early phases are complicated. The systems aren't there to help people collaborate in that way. But clinical information sharing across the right audiences for the right care for the right patient have the opportunity to simplify it and then make it possible.

Rolle: Right.

Marcus: Well, it's been wonderful to have you on the show today, Tricia Lee. Thank you so much for your time. We look forward to great things from you and from ONC in the future.

Rolle: I'm grateful for the invitation. So happy I could be on and talk about all these important topics. I'm glad that you're asking these important questions as well. And this was fun. Definitely fun. Thank you so much.