HHS’s Will Brady on Interoperability, Innovation, and Deregulation

HHS’s Will Brady on Interoperability, Innovation, and Deregulation

Today I’m by joined by Will Brady, the Chief of Staff to the Deputy Secretary and Senior Advisor to the Secretary at the Department of Health and Human Services. It’s a long title, but what it means is that Will is at the center of the major policy decisions being made in our nation’s Health Department.  Specifically, Will leads the three issues we will discuss today: interoperability of medical information such as medical records, reducing unnecessary and burdensome regulations, and modernization of the Stark Law and Anti-Kickback Statute.

Stay tuned to hear Will’s insights into HHS’s approach to removing regulatory burden in health delivery, as well as details on the new, much-anticipated interoperability rules released just a few weeks ago.

Will Brady:       If you compare it to how we live our lives, yeah, some of this stuff is common sense, but our regulatory framework and environment hasn’t evolved at the same speed of technology and innovation.

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Bill Frist:           Today I’m joined by Will Brady, the Chief of Staff to the Deputy Secretary and Senior Advisor to the Secretary at the Department of Health and Human Services. It’s a long title, but what it means is that Will is at the center of the major policy decisions being made in our nation’s health department. Specifically, Will leads the three issues we will discuss today; interoperability of medical information such as medical records, reducing unnecessary and burdensome regulations and modernization of the Stark Law and the Anti-Kickback Statute.

Bill Frist:           Stay tuned to hear Will’s insights to HHS’s approach by removing regulatory burden in health delivery as well as details on the new much anticipated interoperability rules just released a few weeks ago. I’m your host, Senator Bill Frist. Welcome to A Second Opinion. Will, thanks so much for being with us today. And I’d like to give our listeners and our viewers just a prioritization. I know you’re doing a bunch of different things, but if you had to list them what do you do day in, day out for the last three years, we had to say three areas, what would they be?

Will Brady:       So in my role, I’m a Senior Advisor to the Secretary and the Chief of Staff of the Deputy Secretary and so for the senior adviser, it’s all focused on interoperability. Whether it be ONC’s rules coming out or CMS is pushing those to advance access to data.

Bill Frist:           The ONC is?

Will Brady:       The Office of the National Coordinator.

Bill Frist:           And CMS, although everybody knows.

Will Brady:       Center for Medicare and Medicaid services.

Bill Frist:           Yeah, and I’m really starting with that because you do wear so many different hats and you’re right in the middle of so many different issues. So the interoperability over the last two years has been a huge issue and obviously we’re going to come back to that. That’s a big one. What’s number two?

Will Brady:       Yeah. Number two is a deregulation. So being the chief of staff to the Deputy Secretary, he’s the Chief Regulatory Officer. So all regulations flow procedurally through him. So some of the things that we’ve pushed in that is deregulating and de burdening across the whole regulatory spectrum of HHS.

Bill Frist:           Okay. So interoperability, number one, deregulatory number two, another huge issue, especially with this administration and with the current secretary. And if you listed a third, what would it be?

Will Brady:       Innovation.

Bill Frist:           Innovation. Another big one. Another big one.

Will Brady:       The second, innovation and deburdening, kind of go hand in hand, we think as we’ve seen, but it’s been a real focus on identifying where there’s opportunity to for innovation or where innovation hasn’t materialized and how we think about and talk about getting those benefits into the healthcare sector.

Bill Frist:           Yeah. And let’s come back to that because the innovation, people don’t think of government fostering, facilitating innovation and that is one of the three big areas we focus on in this podcast is innovation and health and medicine coupled with policies. So we’re going to be able to hit all three coming through. So let’s come back to the interoperability. Give me an example of interoperability as the setup to what we can talk about.

Will Brady:       Interoperability is just the sharing of information with the purpose of having better decision making at the right time, at the right place.

Bill Frist:           And they’re like medical records.

Will Brady:       Yeah. And so historically a lot of it has been focused on the digitization of medical records. So we’ve seen a lot of progress in that area from HITECH since 2009. Now we’re at the point to where okay, these records are digitized. It’s tough for people to access them or use the data for providers in the way that helps them best deliver care. So our focus on interoperability and following the Cures Act, is to open up access to that information so patients can actually have their healthcare records at their disposal and so they can use them to actually be a part of their care and ultimately better manage their own health.

Bill Frist:           And make it a seamless system. You know, it’s interesting interoperability, when I was majority leader of the United States Senate, I had a colleague Senator Hillary Clinton and at the time, this was all 2006 we put together, the predecessor bill brought it to the Senate floor, it never passed out of the Senate. But it became the predecessor for the 2009 HITECH Act which you mentioned. And then over the last 10 years, we’ve had interoperability defined by HITECH. And so you’ve come in at a point where most records, how many records are digitized today? Is it 10%, 25%, 50% would you say?

Will Brady:       So I haven’t seen real measurements of records, but it’s high. But I think you see 95% of hospitals are using electronic health records over 80% of providers. So you’ve seen a dramatic change in the use of those systems in digitizing records. So it’s definitely in a very, very high amount.

Bill Frist:           So sitting where you are in the middle of so many worlds, what do you do about the interoperability? How do you accelerate it? Or give me an example of a way that you and the Secretary and all the offices that you work in have been able to accelerate interoperability?

Will Brady:       I think the first thing that we’ve really done is one, Cures pass. So we’re obligated to kind of pursue that. And there’s a lot of good stuff in Cures, like the advancing of the use of APIs or Application Programming Interfaces, which are really going to be the pipes for the sharing of information across different EHR systems, different programs and apps that patients can use. So there’s a real focus on the technical side of things and that’s done at the Office of the National Coordinator. And then there’s also the focus on business practices that can sometimes be a barrier to sharing information.

Will Brady:       And so the efforts that we’ve had underway, including what’s in our rules focuses on those things of using technical standards and pathways that have already been adopted and are widely used on industry and expanding the growth of those through our regulatory process. And also defining, “What can you not do that prevents people from getting access to their records or doctors being able to use data and the best way to deliver care.?” So it’s really that focus both on the technical side of things because we are talking about data technology and digitizing that information. But then also just what do we do practically to make sure that what people do every day and every day in and out is facilitating the sharing of information.

Bill Frist:           And the Cures bill became law. It passed, was it two years ago? How long ago?

Will Brady:       Yeah, 2016.

Bill Frist:           And in that legislation, were a lot of the roadmaps for sharing of information.

Will Brady:       Yes.

Bill Frist:           And so you’ve been facilitating and making sure that was executed well is that correct?

Will Brady:       Yeah. So Cures just broadly prohibits something called information blocking and then it tasks ONC with creating exceptions to that. So broadly speaking, information blocking could be anything from having a cost to get it or a licensing term or having a privacy practice. So ONC was tasked with operationalizing that legislation and then creating those exceptions.

Bill Frist:           Does that go through the regulatory system to execute, to operationalize that?

Will Brady:       Yeah. So it’s all done through the regulatory development process. And so in February of last year, we had the proposed rules out for interoperability which set the general parameters of how we’re implementing. And we received over 2,000 comments and tens of thousands of pages on, on our proposals.

Bill Frist:           Walk me through just a little bit just because we’re going to come talk about deregulation as well, but how many months? Walk us through the journey in terms of when regulation to come out, comment period and then digestion of the comments and then what happens? Just walk us through that.

Will Brady:       So there’s a couple points of genesis for a regulation. In some ways, like in CMS, there’s a statutory deadline that CMS has to issue a regulation like on payments for hospitals. And so that’s kind of a backward planning. In others there’s a statutory driver, something like the Cures that compels the agency to take the rule making process at a certain point in time. And then in other times the genesis is an idea from the administration, the executive branch. So that’s how the ideas… a regulation can start. And from there you develop the idea in their proposal and confining within the authorities of the law. So you develop your proposal and your regulation and then you’d propose it…

Bill Frist:           And that’s put into what? The federal register? How’s that proposed?

Will Brady:       Yes. That’s put in the federal register. It’s published in the federal register and then you have a comment period. Sometimes it’s 30 days, sometimes it’s 60. For the interoperability rules we made it 90 because the level of detail and complication that exists at health tech and law. And so then you have a comment period to where industry and other parties can comment on the rules, provide advice and provide their input.

Bill Frist:           And so on the interoperability, how many comments did you receive?

Will Brady:       Over 2000.

Bill Frist:           2000.

Will Brady:       And some of those comments were up to 150 pages, some were 10. You get all sorts of things in the comment process.

Bill Frist:           I know the answer is going to be yes because it has to be, but are you really able to go through all those comments thoroughly and consider them because I know a lot of thought goes into many of them and some of them sure are just off the wall and really don’t apply. How hard is that?

Will Brady:       Yeah, it’s a process but if somebody who’s read thousands of comment letters on different regs, it’s taken very seriously. And we get a lot of good ideas from the comments actually. You get a lot of good feedback on how to tweak what the proposal is to make it more practical for industry or help thinking through how this is going to impact them. We sometimes get so in the weeds, we think this is incredibly clear and then you find out, everybody’s like, “We have no idea what you’re trying to say here.” And so there is a ton of time and effort put into reviewing those comments at all levels. So I can tell you even the Deputy Secretary has sat down and said, “I need to read these comment letters to understand it.”

Bill Frist:           So then that 30, 60, or 90, in this case, 90 days. And then after that, how long do you consider and review those?

Will Brady:       So then it comes to the finalization process and you take in the comments and internally there are briefs on comment review and you start to refine your proposal into the final rule to ultimately be published. There’s really no hard and fast time period for that. You know, sometimes some rules have taken two years to finalize. And then some rules like in CMS’s cases you have to publish a final rule by a statutory deadline.

Bill Frist:           And then once that’s published, is that it or is there an opportunity for appeal or modification after that?

Will Brady:       In some cases there’s technical adjustments and things like that. But generally after the final rule, that’s the new state of play. Now within each rule there are different effective dates and different applicability dates depending on the provisions. But that’s the general process of how we implement and operationalize the regulations.

Bill Frist:           Let’s move to the field of deregulation and again this is a big change from when I was in the United States Senate and the subsequent administrations that so much emphasis is on deregulation. Everybody gives it lip service because we know it’s easier over years and decades of putting regulations out there, but the whole idea of deregulating is really hard. It hasn’t been done very well by previous administrations. Paint the picture for me now of the deregulatory world. Why is it so important and how did we get there? Obviously it’s to streamline, it is to make easier, it’s to make more seamless. But how did we get there where deregulation is such a big part of this administration?

Will Brady:       I think you touched on one, the government does in my mind two real things. We deploy capital and people for certain things and then we set the left and right limits of how people can engage. And that’s done through regulation. So you’ve got limited levers and regulation is a really strong one. So that’s the action you take to influence. So I think it’s piled up years and years and we’re just in the state where you have significant technological changes underway that haven’t been necessarily considered. You have different business models that are existing, different economic impacts. And so you have all these regulations that were designed for different purposes within those streams, and now you’re this I think, inflection point specifically in health care to where you need to figure out how the regulatory environment is either impacting, stopping or stalling the progress that needs to be made.

Bill Frist:           That’s clear and with technology going so fast, the regulations that I read, things like the HIPAA legislation, which was written when I was here 1998 or 1999, whichever it was still those out there is the framework that’s being used where technology and the use of the internet and our mobile devices, it really just doesn’t make sense. But give us an example of one of the deregulatory issues. Either you’re in the middle of or have done over the last two or three years.

Will Brady:       One of the big issues that we’re doing, it’s deregulatory is the reform to the Stark Law and the Anti-Kickback Statute.

Bill Frist:           Stark and Anti-Kickback. I always say them together, Stark and Anti-Kickback. So my first question is Stark and Anti-Kickback is that two different laws.

Will Brady:       Yes. So two different laws but generally have some of the same intense to limit fraud, waste and abuse and protect patients from not having economic incentives influencing providers.

Bill Frist:           So all this started obviously well-intended and written and considered back in the late 1980s, 1989 and then it was actually implemented when?

Will Brady:       So these have been implemented throughout the past couple of decades and that they’ve had different changes. So you’ve got the overarching framework to limit fraud and abuse, but then there’ve been exceptions or safe harbors to each of them, tweaking them to allowing certain behaviors. And so once again, you’ve got a growing regulatory environment that’s done in a one off very targeted manner and that hasn’t really taken the view of them. How are they affecting the entire ecosystem. And that’s where going back to the deregulation, we thought and the Deputy Secretary and the Secretary have been really critical and we’ve got to remove the burden of these regulations. Thinking about the bigger picture of value based care, not one off surgical targeted actions.

Bill Frist:           So this administration and the Secretary have really emphasized the value based care and the words have always been going from a volume based or a fee for service system to a more value based looking at outcomes, focusing on the patient, looking at results divided by the denominator, the inputs or the dollars or the other resources. Is that what’s moving the deregulatory world to make it a more seamless value driven world?

Will Brady:       Yeah, I think it’s definitely a major component from it. Because if you think about moving from volume to value, you’ve got to change how you actually work, your workflows, what your considerations are. And so in thinking that you see a lot of different levers being pulled to drive there one being the Stark and Anti-Kickback regulatory reform space where you’re saying, “Hey, we want people to be able to partner and work together in a more coordinated manner.” And then also so they can figure out what’s the model of delivery there. But then also on the CMMI models where you see a glide path for all types of providers to test taking on risk and being able to think about the total patient, the outcome of the patient as opposed to a process.

Will Brady:       So to get from volume to value, you’ve got to change behaviors, you’ve got to change incentives. And so all these things are being pulled in a way to keep that drive to a value based healthcare system [inaudible 00:17:16], similar to interoperability. If you want to really treat the entire patient, you also got to have the information at hand to do it. And so have been a lot of different efforts that are all kind of flowing up. So how do we actually give people the ability to move in that direction as opposed to potentially just saying, “Oh, your incentive structure changes and just deal with it.”

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Bill Frist:           And now back to the episode, it really is… if you put the interoperability together, which is very patient centered, individuals centered, your record goes with you wherever you are and it transfers smoothly seamlessly and you’re not getting more lab tests and starting over each office you go to or each clinic you go to. Give me an example on the Stark or Stark Anti-Kickback again, just for clarity, an example of physician practice or how it would work.

Will Brady:       So one of the things in the Anti-Kickback Statute I’d say is we talk about changing and allowing the patient incentives. So providers can actually give patients the tool that they think is going to help them best manage their care conditions outside of the face to face interaction. So the example that we’ve used is the smart pill box, right? The majority of seniors are on multiple medications. That’s a tough thing to do.

Will Brady:       So wouldn’t it be great if the provider who’s dealing with a patient day to day says, “Here’s this tool, this pillbox that you can use to manage your medications.” And by the way, I get the data feedback so I can see what’s going on. And so they can actually see what’s happening in their 30, 60, 90 day window from a medication standpoint and the patient has a tool that they know their provider understands and use. So that’s just one example. You couldn’t do that. A provider can’t give a patient something like that.

Bill Frist:           You can’t do that today.

Will Brady:       It’d be an incentive. So it’d be seen as the provider giving something to the patient trying to induce them to come in for federal health care services. But that’s one of the ways where when we say care coordination, we don’t just mean between primary care physician and specialists. We want the patients to have to use the things that we use in all of our other everyday lives to be better coordinated with their providers. So that’s one example.

Bill Frist:           And Stark was put it in there initially not to incentivize the way that would hurt the patient or [inaudible 00:20:38]. So it was well intended, but it’s just with the times as we look to more seamless, more integrated care, it really doesn’t make sense. Really it’s hurting the patient.

Will Brady:       Yeah, there’s still scenarios where it absolutely applies. It has a good intent, but it’s just stifled so much innovation out of fear. I mean, the Stark Law is a strict liability statute, so it doesn’t matter if you intended to or not you’re still on the hook.

Bill Frist:           Another example, I get radiology. So tell me about that.

Will Brady:       If you think about imaging and diagnosis, right? So a physician can’t have any financial arrangement with a radiologist, nor can a hospital or things like that. And so you talk about, “Okay, well is that necessarily the right thing under all circumstances?” Isn’t there as a situation to where we’d want the primary care physician to having a little bit better connectivity with the radiologists, like the use of transferring of files or information.”

Will Brady:       And so that’s where even in some of our reforms we propose to do to allow the sharing of cybersecurity tools or health IT that would be prohibited because there might be a financial arrangement between them and sharing that. So that’s one of the other ways with radiologists where if we can all use the same tool to share images, to transformation quicker seamlessly, we think there’s a way that the regulatory environment should allow for that and encourage those types of innovative solutions as opposed to being the first to know that you see when you kind of say, “Hey, I’ve got an idea.”

Bill Frist:           How much of all this is just common sense? And again, people listening to us, it doesn’t make sense to have this regulatory burden, these big silos of regulations that you have to hop over all the time. And I know you’re out to bring those down, but it seems like a lot of it is just common sense.

Will Brady:       I think there is, but I think it’s also important to recognize there’s a shift in healthcare occurring. So even in the past two or three years, you hear insurance companies saying, “We’ve got value based contracts are up to 60%.” And so there is a pivot to this new outcomes based piece. And so some of the laws that we had in place, the regulations in place were definitely applicable and still have some applicability. But like I said, it’s about what’s the entire ecosystem doing and moving and how are these things either facilitating a drive to that end state vision or how are they hindering? So I think some of the things if you’re in the innovation and tech community, where absolutely I’d want my patient to have the right application or remote monitoring thing for the doctor to be able to understand what’s going on.

Will Brady:       But then you think back to, there’s no way to bill for that, right? There’s no fee for service construct or how you bill for 24 hour remote patient monitoring. So I think if you compare it to how we live our lives, yeah, some of this stuff is common sense, but our regulatory framework and environment hasn’t evolved at the same speed of technology and innovation.

Bill Frist:           And when Stark and Anti-Kickback came in, it was to protect the patient. It was for their safety, for their security. It’s just, as you said, times have changed and as you pointed out, the ecosystem has changed. And with that change, it’s nice to see government responding. When was Stark and Anti-Kickback last addressed? I mean, so much has been written about it lately because you’ve been on the cutting edge with the proposed regulation. Was it last revised in a significant way five years ago or 10 years ago? There’s been an iterative process, but it seems to me that this is a… at least the proposal is a pretty big change compared to past changes.

Will Brady:       Yes. Well, as I said in the past, it’s usually been targeted changes and so right in both regs they allow for an exception to these for employment. So that was done years ago, similar to an EHR donation to where they allow for hospitals to donate EHRs to physician practices. So you’ve always had these somewhat one off changes for a specific targeted piece.

Bill Frist:           So this is a big change?

Will Brady:       Yeah, this is much more. The overall vision is going to value. So we don’t just get to deal with one segment of the industry. The intent is we need to improve care coordination for value based care. Let’s look at the big picture and see how we can create-

Bill Frist:           Cut down the barriers.

Will Brady:       … a platform to allow that.

Bill Frist:           So, shifting to the third area, and I know we’ve covered a lot of it innovation. Again, innovation is one of our three focus points for this particular show and discussion. So I love the fact that you’ve mentioned that. And again, innovation is not usually thought of as a part of government, an example of what you’re doing in terms of innovation.

Will Brady:       I think the first example that I’d say is a little bit unique that we did two years ago. There’s something launched called kidney yaks. And so one of the things that’s abundant is if you look at the changes in treatment for the ESRD population for-

Bill Frist:           End-stage renal disease, right?

Will Brady:       … right. For end-stage renal disease for for 40 years, how they’re treated hasn’t changed much as far as dialysis.

Bill Frist:           Yeah, pretty much.

Will Brady:       It’s talked a lot, you know, nicer chairs, flat screen TV in the center, but the overall treatment hasn’t changed much. And that’s a huge portion of the federal budget and a lot of people are impacted. One of the things that we’re seeing, there was no innovation that we deployed capital directly. So we created a competition at HHS to deploy a couple million dollars in partnership with the Kidney Foundation to actually create capital for people to start using it to innovate directly for the treatment of those with chronic kidney disease. And so that’s I’d say one example of, look, if for whatever reason the incentive structure hasn’t allowed for innovation, we’ve got to take a different approach to thrive there.

Bill Frist:           And that innovation with that incentive, that little X prize, did the good things come of it? Did you execute on that from what you learned from putting that seed money out there?

Will Brady:       Yeah, I think a lot has come from that. One is we’ve started to see people… we’ve already awarded prizes for people developing the synthetic kidney or the artificial kidney. And we’ve seen that. We’ve seen people wanting to change how dialysis actually done in it a lot more interest in that regard. It’s also led and been a part of new models and reimbursement. So when you focus on innovating, you start to see what are the underlying pieces and so from that you’ve seen CMMI come out with a models to reform how we pay for kidney ESRD treatment. And so it’s led to that as well to where it’s not just let’s say, the direct capital innovation deployment, but also going back to the ecosystem, “Where do we need to change about reimbursement and the incentives in the kidney space to where we’ve taken activity to encourage home dialysis and make that incentivize that in a greater manner and also think about how transplants are managed to have better outcomes there.”

Bill Frist:           That’s a great example. And again, this was driven within HHS, working with CMMI, which is the innovation center. Is that correct? All working hand in hand.

Will Brady:       Yeah. I mean there’s a ton of people who deserve… I mean it’s a real team effort, whether it’s from the president on down to the Secretary to the Deputy Secretary to Adam Boehler to administrator Vermont. Everybody really came together to focus on this important issue and something that affects you everybody.

Bill Frist:           And I think the chronic kidney disease and dialysis is a perfect example, a static field delivering great service at real, a lot of costs to the federal government because of the entitlement structure having been stagnant and then the government now coming in, in the last couple of years and really innovating and as you said, they’re now not just demonstration projects but large scale programs that had been a product of that. People just don’t intuitively think government is out there innovating and they just don’t. And probably for good reason because in the past we relied on these large demonstration projects but not the sort of entrepreneurial approach that you just described.

Bill Frist:           One final question, our listeners, medical students, CEOs, policy makers, and when they listen to somebody such as you it’s exciting. I mean the deregulatory world to make life so much better for people, the Stark kind of revisions and other physicians and hospital administrators are listening and saying, “Finally, thank goodness we can deliver value based care and then from the innovative side, the chronic kidney disease.” What brought you to public service? Or was there one pivot point in your life that said, “Well, I’ve been doing private sector, I’ve been doing some software companies.” And all of a sudden, two, three years later you find in Washington, D.C.

Will Brady:       So grew up in a family where my father’s always engaged in public service. So I think for me it was something that everybody should do. I don’t necessarily pursue, but if the opportunity arises, they should serve in the capacity they can. For me, I’d say one of the biggest pivot careers was the opportunity to come out here. Before I came out here, I was somewhat ready to leave the healthcare industry.

Bill Frist:           We’re in Washington, D.C. right now as we’re talking because… again, so people know where we are now.

Will Brady:       So coming from Chicago, I was working for an insurer at the time and was a bout to make a move to leave the direct healthcare space and then the opportunity to come out here kind of popped up and so as opposed to taking a step back, doubled down on healthcare but then also the opportunity to serve and hopefully really make some good changes. So I can say, if the opportunity ever arises, I can’t encourage people enough to jump at it. You get to work with some of the best people in the world, the most dedicated people and you’re constantly learning it and tackling things that really matter. So it was something just I think everybody should find an opportunity to serve if they can in whatever capacity they can.

Bill Frist:           Yeah. You just finished listening to the conversation Will and I had right before the final interoperability rules were released in early March. Now, Will is joining us remotely to give us an update on those rules so that our listeners can hear the most current information. He’ll also share the latest on the federal response to the coronavirus. Will, we talked right before HHS issued the final interoperability rules in early March, and you at that time, were in the final stages of formulating now and now that they’re out, can you give our guests an overview of what was finally included?

Will Brady:       Yeah, so at a high level there were two interoperability rules that HHS pushed out. One was with the Office of the National Coordinator and the other was from CMS. And so the Office of the National Coordinator’s rule focuses on making sure that patients access to our electronic health record data. So what we traditionally think of what’s in an EMR, right? All the clinical data that exists in that system. The CMS record focuses on giving patients access to their payment data with payers. And so Medicare Advantage Plans, Medicaid plans, the individual market plans. And so there’s two rules are from different organizations focusing on different parts of the industry that hold patient data.

Will Brady:       But ultimately it’s about getting that data back to the patients. And when we think about what this really does and the practical instance, patients, there’s so many tools out there and there’s so many applications. For them to be as effective as possible, they need the healthcare data to help drive them. They need to have access to their data to make better decisions about what care they are going to proceed and to shop for care. And so opening up this data really gives patients the ability to have a longitudinal health record on the clinical side, but also on the payment side so they can see their whole world. And we think this will really drive a lot of demand from patients on the care that they deserve to have as well as to be able to shop for care because they’ll know the cure they’ve had in the past, they’ll be able to look for second opinions without having to gather CDs and other things. But we really think this is going to have a huge impact on patients being able to help to better manage their care and make better decisions.

Bill Frist:           Well, we talked a lot in our last conversation about the process and you really helped me and our viewers understand the process itself and sure behind the sames work and the chaos, but the very ultimately how you get to that final product from all that chaos. Describe a little bit, so the regulations are put out on a day and let’s just say it’s been say four or five weeks, what goes out? It goes out in print that day and then do you judge how people respond over the last four or five weeks and if so, tell us a little bit about that response.

Will Brady:       What happens is we publish the rules and we issue the press releases and the fact sheets and all that stuff to give everybody information. And then the rules are published in the federal register and that’s when they become, when the clock starts ticking to abide by the new regulations. And so the response we’ve generally received has been very, very positive both from patients, providers and health IT systems. And that we adopted commonly used standards across the industry from the APIs to the datasets and so what we’re doing now is continuing to inform the parties who it’s applicable to on how things are going to move and answering questions. But so now we’re in that phase of getting feedback and answering some more detailed questions, but we think the regulations out get to a lot of them, but we’re always going to be in contact with the stakeholders that are important for this.

Bill Frist:           Yeah. And so a lot of it is, it can be abstract and one of the things we love to do is we look on this program and podcast is look at this whole intersection of policy and health and innovation. So let’s move to how this really impacts based on what’s happened today, but also as we look ahead, that person who might be listening now, that individual, the doctor, the patient, how does these interoperability rules affect them and how will they change their life, make it more seamless, more friendly in the future?

Will Brady:       I think the first one is that it gives the patients the ability to just have their health record in the same place we have every other component of our lives on our smartphone. And so, I mean, I can share just a personal anecdote of, got a blood test a couple months ago and then when I was in Florida, I had to come to a doctor in Washington, D.C. They asked the same questions and wanted to be able to pull up the lab, wanted me to get another blood test. Well, it just so happened, I took a photo of it so I could just share with the doctor the A1C and all the cholesterol levels and so that doctor doesn’t have to order a new test.

Will Brady:       But I think that’s the most practical example of when we start to let patients have control of that information, they can have that record and those multiple blood tests so that when they go to a doctor, they don’t have to set up a new baseline on what their LDL level is. And doctors don’t have to order a test and then wait for a month to really help deliver care and guide patients. So that I think is one of the most practical examples about how access to that data is going to be an incredibly transformative part of healthcare on care delivery and also the costs of care.

Bill Frist:           How long does it take? You have the rails set out there, you have the train tracks set and then you have to have people respond to it and be probably incentivized in some way. The consumer demand is there because people want a seamless consumer friendly, convenient way to do it. How long do you think it takes to really translate down to having that portable records really a be a reality? Is this months or years?

Will Brady:       The implementation requirements in the rule, and specifically for the Office of the National Coordinator one which focuses on electronic health records is two years to comply. And so within two years every health system and provider is going to have to use the same API or Application Programming Interface, to share healthcare data and they’re going to have to share a certain data set. And so that’s a big shift from the silos that exist in healthcare today. And so one of the things we do recognize is that technological shift takes time, and so that’s why there’s an implementation period that ensures that the right technical standards are being used, the security protocols are in place to give patients that real time access to their data. And so for the EHR piecing specific, they’re going to have to use those APIs within the next two years.

Will Brady:       But the reality is a lot of the vendors and providers already used these APIs. And so one of the things when you break up the rules and to get a little weedy is the requirement to use these technical capabilities to share information. But another is it prohibits what’s called in the 21st century Cures Act, which I know you’re familiar with, is information blocking. And so what that does is even if the technical standards that we’ve prescribed aren’t yet used, when a patient asks for their information providers and IT vendors have to give it to them through a standardized format free of charge to the patient. And so you’re already going to start to see patients requesting their data and be able to get it through other forms which we’ve already started seeing in a couple instances. And so it’s a little complicated in that we say how things should be done and give a glide path there. But we also prohibit if somebody wants their information, people have to provide it to them.

Bill Frist:           Yeah. You know, in this world walking our way through this pandemic, there’s this constant call for data. All the modelers who we are becoming increasingly dependent on as we shift supplies around and we look where distribution should be and responding to where the need is. People basically said, “We need more data. We need to have access to data. We need to not just know whether a test is positive or negative, but what were the symptoms at the time and what were the onset of the symptoms?” And I say all that really to come back to, is there anything in these interoperability rules that will facilitate that sharing of data, accumulation of data? Or is it just in the more clinical side and the revenue side that we focused on?

Will Brady:       Well, I think there’s no question that if the rules that we put out were put in place three years ago, there would have been a lot of improvement in how we can respond because there’d be access to data, there’d be sharing of data that is so relevant to assessing someone’s symptoms, seeing their likelihood of whether or not they’re experiencing or they may have been exposed to COVID. And so I think it’ll have a huge impact on the situation we’re in and the sharing of data piece to where when we talk about how we’ve expanded the access to remote care for instance, in telehealth.

Will Brady:       It’s helpful to have that face to face conversation, but what makes those remote care modalities even more helpful is if the physician and the provider have the data in front of them too. Which right now they can’t get to because it’s locked in some of the silos. So that’s one of the examples of, if a patient has that information and they can control it, remote care would be so much more effective and so much more efficient to really have a huge impact on the type of situation we’re in.

Bill Frist:           Yeah. Fantastic. I know you’re right in the middle of a lot of the telehealth and remote care and virtual care from the level and the perspective of HHS. It’s my general opinion or thought or belief that we really accelerated the telehealth world by, three, four or five years because of the emergency pandemic and the appropriate response and the sheltering in and the staying at home. Just give us your perspective because I know you’re right in the middle of that, at the highest levels in terms of facilitating access for these more remote, whether it’s monitoring or communication or delivery of care. Give us a quick summary.

Will Brady:       Yeah, I think it’s… And I agree to how you put it is pretty accurate and it’s gone years in advance. People have seen the value of it firsthand and they’ve also… the patients have started to demand it and trust it. And so I can share my father in law, who’s a physician when we kind of went out with this, a week later he said, “50% of my visits are now virtual. The patients love it, I love it. The staff is happy that people aren’t coming in who you don’t need to and they could be at risk of exposure.” And so I just think all the different parties in healthcare are starting to see the value of a virtual care and telehealth in a way that would have taken a lot longer. And so it’s unfortunate of the situation had to drive to this, but I think it’ll change. It’ll have such a transformative change on virtual care and healthcare and digital care for consumers, doctors, support staff, everybody.

Bill Frist:           Will, thank you. I’ll tell you, this has been a real lesson for me and I spent 12 years of my life in this town working these issues, but the way you’ve laid out the regulatory process and also this whole goal and mission of simplification, breaking down barriers for people to really fulfill what they want to do and that is help other people and allow patients to get the care that they deserve through having an interoperable system out there. This whole story has been a huge education for me.

Bill Frist:           This episode of A Second Opinion was produced by Todd Schlosser, the Motus Creative Group and SnapShot Interactive. You can subscribe to A Second Opinion on Apple podcasts, Spotify or wherever you are listening right now. You can also watch our interviews on YouTube and on our website and be sure to rate and review A Second Opinion so we can continue to bring you great content. You can get more information about the show, its guests and sponsors at asecondopinionpodcast.com. That’s asecondopinionpodcast.com. A Second Opinion broadcast from Nashville, Tennessee the nation’s Silicon Valley of health services where we engage at the intersection of policy, medicine, and innovation.