The final rule has been released and it is as impactful as everyone thought it might be. Dr. Don Rucker the National Coordinator for Health IT for the ONC stops in to discuss the rule and its impact. Hope you enjoy.
The final rule has been released and it is as impactful as everyone thought it might be. Dr. Don Rucker the National Coordinator for Health IT for the ONC stops in to discuss the rule and its impact. Hope you enjoy.
[0:00:04.5] BR: Welcome to This Week Health Events where we amplify great thinking with interviews from the floor. The floor happens to be my home office this week but the interviews are going to go on. Special thanks to our channel sponsors, Starbridge Advisors, Health Lyrics, Galen Healthcare, VMware and Pro Talent Advisors for choosing to invest in our show and the next generation of health IT leaders.
My name is Bill Russell, healthcare CIO coach, and creator of This Week in Health IT, a set of podcasts, videos and collaboration events dedicated to that purpose of developing the next generation of health leaders. We’re going to go on the record that today, right now, with Dr. Don Rucker, the National Coordinator for Health IT for ONC.
Appreciate him coming on the show, a lot going on right now, we cover all things 24th century cures act as well as the final rule which just came down on interoperability so hope you enjoy.
[0:00:52.0] BR: Dr. Don Rucker, National Coordinator for Health IT for the ONC, thank you very much for joining us, really appreciate it.
[0:00:58.1] DR: Yeah, it’s always great talking with you Bill.
[0:01:01.5] BR: I appreciate. The proposed final rule coming out this week. This is a – you know, from where I sit, having been in healthcare and you as well for many years and seeing all the challenges since we rolled out the HERs and the interoperability and all the challenges people have had still getting their medical record, the innovators trying to tap in to the medical record and provide value, this appears to me to be a pretty seismic event within healthcare and healthcare IT.
Is that how you guys are viewing this?
[0:01:31.5] DR: Yes, I think that is a fair statement so the challenge has been historically, it has been largely technical, right? Historically, you know, I start in the day of you know serial reports on computers and most of your audience probably don’t even know what that is. Parallel reports on computers and most of your audience probably doesn’t know what that is.
But over the last 35 years, really, 40 years, we’ve gotten a lot better and so, you know, if you look, compare it to let’s say in the 80s, you know, in the 80’s, we had the computer science, you know, the algorithms we had, but we didn’t have the compute power, we didn’t have the data, we only had compute on and we certainly didn’t have the networks to share that data or make it interoperable. Applications were really almost by definition standalone activities.
You know, in the 90s, you started seeing some of the client server type of approaches but today, we have for the most part and most of the country, widespread broadband and of course, with the EHRs now being almost totally electronic, we have the data and we have the compute power. So now, I think what’s been missing is a little bit of the will and the business case really as much as anything else, right?
Because obviously the rules are more geared to addressing behaviors rather than inventing new technology and the challenge has been from a behavioral point of view that in this third party world over the – with lots of cross subsidizations over all the decades, we have created incentives that are very much – I won’t say they’re anti-consumer but they really ignore the consumer, right?
We don’t have as consumers, the kind of choice that we have than the rest of our commercial lives. Because, everything in healthcare has been abrogated to various third party decisions so the payers, providers, the government, as supposed to having a one to one between the patients and providers with maybe the insurers as catastrophic insurance and, you know, questions of equity than through a similar kind of mechanism.
We have made almost first dollar – I know people have deductibles and copays but from an economics point of view, we have made almost first dollar go through the hands of third parties. One way or the other, whether it’s calculations or deductibles.
Obviously, that world, the incentives that we have created and that people respond to, have led to very consolidated delivery systems. The basic, how to be a successful CEO in healthcare is really a, “Buy as many hospitals, merge as much of the business as you can to be a price setter, to payers.”
Well, in that kind of a world, your concern is not interoperability and a seamless consumer experience. It is having to prevent leakage. All of a sudden now, the business case for sharing has to really come from the public sector, it really has to come from rule making, you know, from patients, from employers to say wait a minute, we’re left out of this game and this equation and we want to have smooth, functioning access to our data. We want data in public ways that we can access. That has been the component that has really been missing and that’s the component that the cures act and our rule put into place.
[0:05:42.1] BR: That is a good foundation for the why. I’d like to walk through a handful of things so the interoperability technology, the business models, the protection of intellectual property which is one of the things that this really helps with, the data. Talk a little bit, we’re going to talk a little bit ab out USCDI and the foundation for that and then the behaviors, we’ll come back to the behaviors because we still have to we fundamentally have to address those things.
I found this as – the more I keep looking at this, this is not thrown together, this is very well thought out over many years. This has been in the works for a while so the technology is based on API’s, based on FHIR, I guess version four for FHIR, their certification, HL7 certification body’s going to maintain those API’s so we’re going to have a fundamental framework that most developers understand, most EHR providers understand and a way to connect these things. Talk a little bit about the interoperability technology and then we’ll move on to some of the other things.
[0:06:43.4] DR: Yeah, looking at the technology stack, you know, that has really evolved in part and parcel over the years. I think the – probably the biggest events, the two biggest advances I would say in the technology and the really software, right? Because we’re using TCP IP in the Internet and all of that provision.
But one is the RESTFUL, the concept of a RESTFUL API. Restful is a combination of an acronym and a modifier. The acronym is the capital letters REST and then the modifier is the FUL. REST stands for representational state transfer and what that really says is simply rather than sending over the data with, you know, intermixed with instructions, it really says, send a data over as just a pile of data, a much simpler thing to do and then, you know, the instructions can be done on site.
And then there is a gentleman named Graham Grieve from Australia who has started putting that into a format for healthcare called FHIR which stands for fast healthcare interoperability resources and as one might imagine is the sea for many puns of which OMC has been guilty of several as well. But that combination of things is a powerful, it is what drives most of the Internet.
Developers who aren’t steeped in some of the prior healthcare-specific technologies. HL7 version 2.5 was made a classic inter op software protocol. For content, HL7 now is sponsoring FHIR. I think we’re making that transition and it has the practical matter of letting a lot more people play in the healthcare game based on their skills in open source tools, right?
We’re not talking about things that almost get to the black parts of programming that are you know, very unique to healthcare skills, we’re talking about you know, things where a lot of folks can be contributors and provide ops to the public –
[0:09:31.9] BR: Yeah, I was looking at this and it’s not just for the consumer, although, the consumer’s a big part of this. There is – you now support FHIR in bulk or bulk in FHIR, I’m not even sure what the acronym is but it’s going to give me the ability to move population health data around and be able to move clinically integrated network data around which we always struggled with because our clinically integrated network, we didn’t control the EHR so we had many.
If we were able to bring that data together, we could be able to look at the quality of measures across that entire network which was amazingly difficult prior to this. There are mechanisms within this, not only for the consumer but also as a foundational layer for interoperability between health systems, between providers and others.
[0:10:14.5] DR: Yes. When I got into this in 2017 as coordinator and was, you know, doing research on what should be in the role and how to advance these standards, sort of the core coordination functions that ONC does. In talking with folks in particular Ken Mandl at Boston Children’s, it became clear to me that when we talked about FHIR and queries, there was something truly funny going on which was that these queries only returned an n of one. They were designed to return a single record.
To somebody who has formally studied database science, like, “What? The query only returns one record?” I mean, this was unfathomably primitive to – in talking with Ken, who had led to work on the arg on that standard that made the initial query of one, right? Getting the patients record to communicate with an app, that all made perfect sense, we talked about what would take to simply extend it, right? It’s not a huge issue to extend this given you’ve already represented the data in FHIR, right? The heavy lifting is already done. This is the simple part of the iteration arguably.
At the same time, we heard the same things Bill that you just described. We heard that payers who are you know, our agents and buying healthcare can’t actually get at electronic medical records any practical way to see what they’re buying on our behalf, right?
You know, either you have to do bespoke, one off queries, I know that’s redundant, or you have to do – you have to get paper records or you have to pay, we’ve heard reports that major payers had to pay EMR vendors $5 a pop to get the electronic medical records, you know, that they already had a legal title to, because they were the payer and you know, payers get to see the medical record. All of that is a very horrible way to buy healthcare.
We came up with – initially, when I was talking with Ken, you know, just I called it well, you know, bulk FHIR, that’s not an acronym, it was just a conversation I had with Ken, it seemed little inharmonious. We’d heard some suggestions to call a population level data, I tried doing that but shorter words went out over longer words. I think we’re coalescing on bulk FHIR.
If I realize it was going to have legs, I’d probably would have thought about it and done it, named it something a little bit more tasteful but the point of it is, as you point out, profound. When bulk FHIR allows is that providers, on their own which often they have not been able to do have an ability to get data out of their systems and use that for their purposes. Big data analytics.
It means that providers, I mean, payers, will be able to actually measure performance of providers and contract accordingly. Today, if you’re a payer in the US, to decide who is a network, you know, the only real decision points are fundamentally three. You know, one is, are they so big that you have to have in your network, because you know, they’ve consolidated that you don’t have a choice effectively if you want to be in business. The second is, well, they give you a great price or a better price or some price you can live with and then the third is, is there somebody you want for reputational reasons, you know, they’re world famous.
Notice and that list of three things, know where was there any actual discussion of bona-fide measurable quality, right? Can you imagine in our consumer lives, if we bought stuff without figuring out whether it was any good, right? Could you imagine going to a grocery store and buying food without some protections on safety?
Could you imagine, I mean, buying anything without knowing as much as you can about the product. That’s the way we’ve been healthcare. What we’ve done as a – you know, starting where there was circa 2000, when Medicare went from any willing provider, as a payment requirement to paying based on value. We’ve tried to come up with this very brittle proxy for value called quality measures. They’re on very small sets of data, it’s heavily lobbied, their lobby to be set the bar about a half inch above the ground on the provider side, they really don’t add much but at the moment, they’re the only show in town here.
In a big data world, if the payer has accessed all the data, it is easy to use any machine learning algorithm and separate providers to whatever granularity of quality you want, whether that’s quartiles, quintiles, deciles. Whatever granularity you want and it will be way more reproducible than the current almost random measurement of quality.
I think you absolutely hit on the fact that if we have the APIs to make this doable, as opposed to a swamp of excuses, we’re going to have a lot more potential accountability and you know, that accountability of course is not just on providers but it actually, there is mirror symmetry that payers will have to actually figure out what they’re doing to add value.
It’s very profound, I think it’s important, it’s modern and it’s I think what congress was looking for when they said application programming interfaces without special effort.
[0:16:18.0] BR: Yeah, one of the things, the next thing that people are going to talk about is the data, right? You’ve seen the EHR data, I’ve seen the EHR data and it’s kind of sloppy so USCDI steps in, defines the data classes, defines the data elements and gives a mechanism for future data sets and data elements as well.
Give us an idea of what people can expect upfront from this. Obviously within the 36 month timeframe or the implementation. I think we ended up on 36 months, right?
[0:16:54.8] DR: Wow, it’s a bit nuanced so the information blocking for the first two years, starting from month six to month 24, the information needs to be released is US core data for interoperability.
There is allowance for different formats for releasing that, what’s called a content and manner exception. What is the content you have to release and what is the manner you have to release it in and the API’s, the US core difference operability, that API kicks in 24 months after the role posts and then the broader data formats kick in at 36 months.
[0:17:36.0] BR: The clinical data, it’s going to go cross that, the typical pay me data problems, allergies, meds, immunizations.
[0:17:42.8] DR: Yeah, things that had been added there from the common core data set we’ve already had in our certification program are clinical nodes and some providence data. Some better demographics for patient matching.
[0:17:56.1] BR: So one of the big exciting things from where I sit is the insurance data actually flowing back and forth as well, so not only is it the insurance carriers can take a look at what the providers are doing but the providers can now integrate in terms of research and other things some of the insurance data but what insurance data? Have we defined any insurance data that’s going to moving yet or is that in the future?
[0:18:19.4] DR: Yeah, I think there is some early work in CMS with the blue button work for the CMS data but I think a lot of that is still a work in progress. The intent is to use as much – well to use FHIR to do that but you know there is still work to be done there.
[0:18:37.6] BR: Yeah and no revenue cycle data yet. That will come at a future date out of state.
[0:18:43.7] DR: Yeah well, so the CMS role in – we should really ask CMS about their role, I’m a little bit out of the bureaucratic swim lane if you will in talking about other agencies roles but obviously there will be claims data there so there will be a version of revenue cycle data. I think that the concept there is in fact that that serves as a quality measure because ideally the clinical data and the revenue cycle data should sort of match up when you get right down to it.
I mean I wouldn’t wait for that to year one of the rule but overtime, it is not hard to imagine the writing software to make sure that they match up and are in sync.
[0:19:31.0] BR: So in our time here, I want to hit on practices. So some of the things that you have seen over the years is the EHR contracts, just contracts in general that house this data. They have certain NDAs, confidentiality agreements, hold harmless. It is just a whole bunch of stuff in them that essentially, that is the antithesis of – it doesn’t allow us to share the data and it doesn’t allow us to get a clean view of the data.
So we now have to address behaviors. We put the technology foundation in but as we know in health care, the behaviors don’t naturally follow because there is no financial incentives in a lot of cases to follow. So you really do have to put a stick in place. So there are and I have heard – I’ve interviewed entrepreneurs who refuse to go on the record because they don’t want to get on the wrong side of EHR providers but they say, “Hey, if I go into their app store.” Which is, “Hey, we have an app store, we’re interoperable,” they have to pay to access the data. They have to pay a fee for something else and they have to essentially give away their intellectual property in order to participate in the app store. So this addresses a bunch of that as well to sort of level the playing field.
[0:20:42.8] DR: Yeah, so we’ve heard multiple complaints about those behaviors as well. So for the US core day – so first of all, our rule, the rule that we have just released is for a write-only rather than read-write into the EHR. That is a whole separate conversation. You know there is a delicate balancing act here between accessing data, protecting the IP of the EHR vendors. I think there are a couple of stored of conceptual points that provide sign posts here.
And so first of all, the biggest one is other than an individual right of access, all any other data access is covered by HIPAA. These are HIPAA covered in any business transactions. So all the big data, any use of the bulk API would be a HIPAA contracted transaction between a covered entity and a business associate or within the covered entity. So that has to be clear because I think sometimes some of the people who don’t want to share data sort of get very sloppy and claim, “Oh all of these data can be downloaded” that is in fact just simple untrue but that is said by a lot of people because they like to say it.
We’ve heard a number of complaints on API pricing schemes that have the effect of interfering with our access exchanging use of electronic health information, which is what’s required under the Cures act. So in order to address that – and you could argue of course that any feat interferes with that, right? I mean by definition.
But in order to balance the fact that any fee interferes with this but you need revenue streams to have these API’s, we’ve come with these core API’s. For example the API that a provider would need to buy from an EHR vendor to be able to give data to patients for free, right? So it’s not free, it is embedded in the cost of health care. It’s the cost of doing business just the same way I have to buy a medical license. It turns out that’s not tax deductible, whatever. There is lots of costs to doing business. That is a cost of doing business in a regulated world.
So those APIs that support that access and those that class of APIs have to be costs reasonably incurred and with reasonable profits. That we’ve defined, which you can read in the rule but amongst other things it does not include, “Give me all of your IP,” and it has to be done on a non-biased fashion so that you can’t say to some app vendors, “Okay, with you we’ll do business, but some other app vendors, “You know we might want to be in this space in two years. So we are going to take your ideas, build out our own product and not let you hook up,” so it has to be on a non-discriminate, the licensing has to be on a non-discriminatory basis. So that part of it –
Now if there are value add, if there are other business services, those things that go beyond the USCVI, those are whatever the market rates will bear. Our assumption is that over time, just the transparency and the visibility into how to use these API’s and what their costs are and just customer demand of EHR vendors, will sort of bring this into the something that’s reasonable, even if they’re one set or not protected under the Cures act.
[0:24:35.3] BR: Yep and this is 21st century Cures act is interesting to me in that it really does, we talked about this the last time you were on the show. We talked about creating a market and now we’ve essentially created a market for cures, we have created a market for experience. We have created a market for quality and accountability within healthcare because we opened up the data, which is the first step as the necessary step.
So what do you envision? Give me some ideas of the things you envision are going to come out of this as a result of this moving forward.
[0:25:08.5] DR: Yeah, you know I think it is going to be a sequence of things, right? I mean these things take a bit of time to launch. So I think, as you look at the tranches of products that might come out, I think the initial ones will be – and there are already a number of them out there now from large companies like Apple to smaller companies like Mypatientlinks, HARO Health, a number – CU metrics. You know you are going to see initially versions of the electronic medical record.
I think you are going to see explanations of what’s there, what the tests were or what the services were, maybe interpreting the record. Over time, I think you will see things that we engineer care. I mean right now, chronic care, very episodic, but as we can instrument more of our bodies with all of these amazing technology, you know we’ll be able to tighten the feedback loop between treatment, diagnosis via the smart phone and treatment where some of these that you know, even if that’s just pills because we’ll have tightened that loop a lot more.
So rather than visiting your doctor and getting a blood test every so often. Let’s say there were tests that could hook up to a smart phone or glucometers, which is the case today or peak flow meters or heart rate monitors. The Apple watch would be a perfect example. All of a sudden, we are tightening up all of that. I think you are going to see an incredible mix of things.
I think even see not just from the President’s executive order and the rule making that the administration is doing on price but I think even just for market forces, you are going to see all of these things wrapped up with price as people can start shopping, right? Because if you don’t post your prices and as otherwise shop-able people are going to go to where the lowest price is. That is America, we know that. You can ask Jeff Bezos if you have any doubt on how that might work. I think he can probably explain it to you. So I think there is going to be a lot of transformation.
If you think about the internet of things, which I am sure some of your audience has thought about in terms of healthcare, right? The smart phone is essentially our computer network in our homes on some level, right? So if you get the medical data to the smart phone and then anything else you hook up to the smart phone, you create a much broader environment than just it’s an app. So that is my sort of belief of what is going to play out here.
[0:27:45.4] BR: So last question and I appreciate you giving a couple of extra minutes here, you know there is going to be laggers who step back and they say, “Well, you know we’ll see what happens in the election. This will change just like other things would change if this administration gets moved out but as we’ve talked before this is the 21st century Cures is by partisan and a lot of the work that is going on at ONC and HHS is just a continuation of work over decades.
I mean it’s really been kind of consistent of moving in this direction. So there isn’t – the lagger doesn’t get to sit back and say, “This isn’t moving forward,” this is pretty solid. What would you say to those guys?
[0:28:24.0] DR: Yeah, look, “The American public is unhappy,” would be an understatement with American Healthcare. It screams out for transparency. It will happen one way or the other no matter what the party is. The Cures Act rule is quite bipartisan. The Cure’s Act itself was voted almost unanimously, the work on information blocking was done in the prior administration, the law writing was done, you know, the work of prior administration in both parties as I think folks are quite aware.
The president is extremely interested in having Americans being able to shop and control their healthcare. It is the center point of all of the executive orders of all of the policy making as well as creating markets in things like drugs to have things to shop for and frankly, I believe that search for transparency is global. It is part of the age we live in, maybe there is too much transparency sometimes and you know in social media.
But it is a global phenomenon and I think people have to providers, payers, economic parties here are going to ask to if they are working as most folks are on somewhat or highly non-transparent business models. They are going to have to really start thinking about what does my world look like when people can shop with information and control their destinies, you know. What is going to be the mix of products, what’s the mix of services, what’s the mix of prices?
You know it has been dammed up for 50 years, 55 years since Medicare started setting administrative prices and arguably going back to 1942’s Stabilization Act that made health care pre-tax. So we have non-market prices now for pretty much everybody’s adult lifetime and pretty much everybody’s entire lifetime if you go back to 1942. If we get market forces into health care, that will unleash something truly amazing.
It will be great for the country because it will make us more efficient and competitive. It will allow real wage growth. Obviously for those of us who are in the healthcare space I think we are going to have to rethink some of our embedded assumptions.
[0:31:01.2] BR: And with this show, I will post a bunch of links underneath. I think a lot of health systems are going to start doing their gap analysis like, well, they should have started six months ago because that writing was on the wall
[0:31:11.5] DR: Probably, if I can say one thing there, you know, we have tried to make this world from a provider point of view and even from a developer point of view be actually a very straight forward thing. I mean, if you think about, I know there is a lot of back and forth about all kinds of things but ultimately what’s required here is the database driver and whatever format you have as a database hooked up to a server end point if you will, which obviously the EHR providers will presumably provide thought others could arguably provide it.
So you as a provider obviously you have to maintain that endpoint and the IP address on the internet but you’re basically hooking up a server to the internet in terms of costs. This is something that I think is quite doable from a hassle point of view. This is not one of these things where we are touching a thousand pieces of the system. You know frankly like some of the things in meaningful use work.
Where all kinds of behaviors have to change, behaviors will change here but they will change because of market economics.
[0:32:22.9] BR: Yeah, it is a FHIR server to isolate the eye.
[0:32:25.9] DR: They are not going to change because of, “The rule says you have to change your behavior,” it’s you’ll want to change because you know there is that accountability.
[0:32:35.5] BR: Well and I also think – well anyway, we could keep going. I think there is a lot of benefits internally for an HI, health IT organization. I think once they get past the initial shock, they’re going to see great benefits.
[0:32:47.3] DR: Yeah, all kinds of opportunities. All kinds of opportunities to rethink what they are doing, get smarter and better at it and actually control their own data. It’s really the modern way to go. I mean the healthcare we have been the only sector in the economy that hasn’t done this kind of stuff. Everybody else does this. I dare you to name an industry, a major industry in the US where these kinds of analytics and approaches aren’t part of common work.
So it is going to be exciting. It is going to be good, it’s going to be good for the public. I think providers who are offering valuable services will be well-rewarded.
[0:33:29.3] BR: Yeah and if you were CEO right now, you would be pulling your strategy people and then saying, “Look, we just got – this thing just opened up. In the next couple of years, we’re going to be able to provide a whole new set of services. So let’s start brain storming but what can we do?” and yeah. Well Don, thanks always, great show. I really appreciate your time. I’ll post a bunch of links so you don’t have to go through all of the proposed rule stuff. People can hit the episode and then go from there. So thanks for your time, I really appreciate it.
[0:33:58.0] DR: All right Bill, it was great. As always, great talking with you. Take care. Bye-bye.
[END OF INTERVIEW]
[0:34:02.2] BR: Yeah, special thanks to Don Rucker and the team at ONC for making him available for the show. I really appreciate it and as I said, I am going to put links on the page itself. So if you are listening to this in your car wherever, when you get to the office hit the page link. It will have a bunch of links to the ONC proposed rule, what’s the difference from the proposed and the final rule and a bunch of other things like that.
Awesome, so don’t forget to check back a couple of times this week. We are going to be recording a bunch of shows. I have two more recordings going on later this afternoon, it’s a Tuesday afternoon of HIP week. Tomorrow I think I have three or four more interviews already scheduled and that may not be all. So this week that’s what we are going to do, next week we go back to our normal schedule. We’ll have Tuesday Newsday and then on Friday we’ll do an industry influencer conversation.
So this show is a production of This Week in Health IT. For more great content, you can check out the website at thisweekhealth.com or the YouTube channel as well. Thanks for listening. That is all for now.
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