REFILL | Naomi Lopez on Healthcare AI, ACCESS, TEMPO, and the Future of Care (Originally Aired: January 23, 2026)
DC EKG
This episode of DC EKG features Naomi Lopez, founder of Nexus Policy Consulting and co-host of the inaugural Healthcare AI Policy Summit, disc
Key takeaways
- The HHS is promoting a lighter-touch regulatory approach to accelerate the adoption of AI tools in healthcare.
- Access and TEMPO represent new payment and regulatory models that enable real-world evidence for chronic disease management technologies.
Main topics
- Healthcare AI Policy
- Medicare Innovation (Access Model)
Notable quotes
We only had one day, but we could have spent multiple days with Jim alone in talking through some of these issues.
Conclusion
Naomi Lopez highlights an exciting era of healthcare transformation driven by AI innovation, regulatory
Transcript preview
Speaker 2 (0:03) This is DCEKG, exploring the intersection of politics and healthcare by diagnosing Washington and prescribing solutions. We take a deep dive into the legislation, regulation, and innovation impacting policymakers, providers, and patients. Now, America's health policy expert, Joe Grogan. Speaker 3 (0:27) Welcome back to DCEKG, the most informative healthcare podcast out there. I'm really excited today to have Naomi Lopez with me back again. She's the founder of Nexus Policy Consulting and the recent co-host with me of the first Healthcare AI Policy Summit, which we hosted together last week, December 10th at NEDS. Naomi, thanks for coming. Speaker 1 (0:54) Thank you so much for having me. Speaker 3 (0:56) So let's walk a little bit. I thought it was a great conference and I'm going to give you all the credit in the world because I didn't want to do it. I was swamped. I was busy. I'm like, okay, I need another thing to do like a hole in the head. But it was a great conference. You did a great job. It was your vision. And thank you for pulling it together. Speaker 1 (1:20) It was my pleasure. And I think that, you know, we've We started working together about two and a half years ago on the Healthcare AI Working Group, which was an informal group of healthcare slash other policy area experts in order to build a bench of healthcare AI experts in order to ward off some of the Biden administration's regulatory overreach on AI. And this was just a logical extension of it. So I think that our partnership over the past couple of years has been very, very productive. Speaker 3 (1:54) Yeah, thank you. Well, it's been a pleasure because you certainly are an expert on state healthcare policy, but state policy general, legislative procedures, and the machinations in all 50 states in a way that I certainly am not. So it's a great partnership. It was a pleasure to work with you. So let's get into it. We had this thing, it was a busy week in D.C. for AI policy, and I thought it was timed very well, and I'm glad we got it in in 2025. So we started off the conference with the Deputy Secretary of Health and Human Services, an old friend of mine, Jim O'Neill, who came and was very generous with his time and talked a lot about the department's approach to AI and where... They want to go. Now, Jim is a veteran from the Bush administration where I first got to know him, where he worked at HHS. And then he had spent a number of years out in Silicon Valley and working with Peter Thiel. But he's got an entrepreneurial bent. He's got a tech bent and a libertarian bent. And he's very focused on. trying to create an environment for new technologies to flourish, get adopted, get regulatory approval if necessary, get reimbursed if necessary, and improve the human condition in healthcare through new technologies and innovation. So that was a great way to start the day. I interviewed him, so I was probably more nervous about not forgetting anything that we wanted to ask him. And I'd be interested in your impression of the interview and your takeaways from what Jim had to say. Speaker 1 (3:40) Yeah, I thought it was a fantastic session. And actually, all of the sessions were fantastic. But I really appreciated. So he brought this high level of institutional knowledge and regulatory know-how back into this position. And, you know, we have a lot. We had a lot of innovators throughout the day. But I think what he what is a huge value add to our day was that he's an innovator inside government. So he understood very clearly the need for regulatory clarity, the lighter touch regulations and streamlining the approval process for AI and machine learning enabled devices and tools. And the other interesting thing that he brought was he is also helping to. promote the adoption of AI within government, which he also, which you guys also talked about. So I think that there are multiple levels, his ability to not only make the ground more fertile for AI by providing the regulatory clarity and streamlining, but also to make government operate more efficiently. We know we've had, you know, decades ago, we had, you know, a lot of initiatives about making government better. But this is truly one way that government can be streamlined. You can remove a lot of the duplicative tasks, really focus people on higher value add within government. And so I think that, you know, we only had one day, but we could have spent multiple days with Jim alone in talking through some of these issues. And so it's a really exciting time. Access and Tempo were both announced recently. Speaker 3 (5:22) Why don't you talk a little bit about those initiatives? Speaker 1 (5:25) Sure. So AXIS is an outcome-adjusted payment model for Medicare, for chronic disease management, under four areas, four key areas, high blood pressure, diabetes, musculoskeletal pain, and depression. And so these four chronic areas affect more than two-thirds of Medicare beneficiaries. So what they're doing is they're bringing in a new model of payment to demonstrate it over the next 10 years. to really provide real-world evidence, proof of concept. Meanwhile, TEMPO is an FDA initiative that is going to also be a new risk-based approach to regulating new tools in chronic disease management. So what they're going to do is they're going to allow 10 non-certified tools in each of these four disease areas to be piloted and using that real-world evidence to hopefully create another pathway for the more rapid adoption. and more efficient adoption and post-market surveillance, et cetera, on these kinds of tools. There's not a really good fit right now in the FDA for approving these tools. And we can talk about that more in our discussion today, but it really does show this very action-oriented HHS. And I think that there's a lot to be excited about. Speaker 3 (6:39) Yeah, I mean, the access model just to... Hit on that. So that'll come out. That's coming out from the Center for Medicare and Medicaid Innovation, which is run by Abe Sutton, a really good guy who we used to work together in the first Trump administration. But one thing that's interesting about it is, you know, for so many of these chronic diseases, for Medicare beneficiaries, the new wave of AI-enabled technologies that we wouldn't consider traditional medical devices like Well, I'm wearing a Garmin right now. You could see devices like this getting configured to monitor blood sugar content, monitor heart rate, monitor any number of things based upon different inputs that it's taking, then flag these for your physician, for a nurse practitioner, somebody out there who can intervene and get you on the right track. So you're not cycling through this series of ever deteriorating conditions or. crash and burn where you're going fine and then you you're slipping and you don't even realize it but there are devices and wearable tech that could that could flag that for you and then of course that's a ton of expense you know the chronic conditions are a ton of expense in the federal government but these episodes of catastrophe in the emergency room are a tremendous expense as well well Speaker 1 (8:01) and to provide additional context on what this could mean in the long run When we think about the ability to remotely monitor patients, we now have ICUs where the patient is actually in their own home, surrounded by their loved ones and caregivers in their own bed, which has a huge impact on the cost of the episodic treatment for that patient, not having to be in the four walls of the hospital. But also, when we think about the Medicare population, we know we've got an aging demographic in our country. And we're going to have to reckon with that. The cost of long-term care will be borne by the states. Medicaid will pay for long-term care for some populations, for those that qualify. And when you're talking about $50,000 to $75,000 per year per patient for long-term care, which is usually not very good in this country, unfortunately. Speaker 3 (8:55) Right. The Speaker 1 (8:56) ability to remotely monitor patients and allow them to age in community can have... substantial impacts on state budgets. Most people don't realize that states are required to balance their budgets every year. They don't have a printing press. Those are legal requirements on states. And those dollars squeeze out money for other high-priority expenditures like education and transportation. So we really do have, what I'm really excited to see, is that there can be significant impacts on state budgets, but also the quality of life for our aging population in this country. Speaker 3 (9:35) Yeah, it's a really good point. Let's go back to Jim for a second. There were a couple of things that I took away from that conversation I thought was interesting. One was his libertarian instincts came out on a number of these issues where I think a lot of the media narrative is. AI is running amok. The AI bros are running amok in the administration, the Trump administration, by jettisoning the Biden administration's completely prescriptive hostility towards AI and really focused on government control of this technology has somehow lacked skepticism of people using AI for nefarious purposes. I thought he was very clear that he doesn't see it that way. As a matter of fact, I was pressing him on a bugaboo of mine, which is the government doesn't release the data that it has for people to research and evaluate. And I said, you know, look, it has tons of claims data and CMS that could be put out. And he said, yeah, it could be. But, you know, with AI, you could figure out who these people are, an individual patient, if it's not done properly. And kind of said, yeah, that is a focus to get more. government data out there for public consumption. He was focused on using AI, for instance, for better predictive modeling on pandemic and epidemic response. But it was interesting that because he's an innovator, because he's been in private industry, he isn't either openly hostile or totally gullible. He knows what the opportunity is, but he's also like, wait a second, people could use... We have to be careful on a couple of these things. Otherwise, we could end up regretting it down the road. Speaker 1 (11:19) Yeah. I mean, I thought that was a really important point about de-identifying data. A lot of patients, rightfully so, are very concerned about their data being shared. You know, whenever you think about, for example, if you have a patient with a rare or ultra-rare disease that lives in a certain zip code, it would not be that difficult in a year or two to figure out exactly who they are and, you know, who their family members are. The other thing I thought was really fantastic that came out of the panel were when you asked him about Chai, when