In this episode of 4x4 Health, we talk about information blocking with Michael Lipinski, Director of the Regulatory Affairs Division within the Office of the National Coordinator for Health Information Technology (or “ONC”). Mike has been with ONC since 2009 and currently leads HHS development of Health IT regulations. He is one of the nation’s foremost experts on the state of information blocking and was a key contributor in the creation of the proposed ONC rules on interoperability and the free exchange of health data. This episode is a remarkable opportunity to dive deep into the intricacies of the new rules, the challenges they are attempting to address, and the solutions they propose. Throughout the conversation, information blocking emerges as a clear passion for both Dr. Dave and Mike; their discussion about its current and potential harm is a powerful reminder of the urgency and importance of these new proposed regulations. Here are some quick links to the rules themselves, the commentary template referenced by Mike in the episode, and where can post your comment directly.
Dr. Dave Levin: Welcome to 4 x 4 Health, sponsored by Sansoro Health. Sansoro Health, integration at the speed of innovation. Check them out at www.sansorohealth.com. I’m your host Dr. Dave Levin. Today I’m talking with Michael Lipinski, director of the Regulatory Affairs Division within the Office of the National Coordinator for health information technology, usually refer to as ONC. Michael’s been ONC since 2009 and currently leads the development of regulations and contributes to HHS policies, regulations and initiatives that support the adoption and use of health IT. Electronic health information exchanges and patient’s access to their health information. This puts Mike at Ground Zero when it comes to the Federal Government’s current efforts to promote interoperability and the free exchange of health data. The recently released proposed rules from ONC on interoperability and information blocking are getting enormous attention as they should. These are some of the most important issues in health IT today. Mike has played a key role in developing these proposed rules and we’re delighted he’s here today to talk about information blocking. Welcome to 4 x 4 health, Mike.
Michael Lipinski: Happy to be here. Thanks, Dave. I look forward to discussing some of the things in our role today. Particularly information blocking.
Dave: Excellent. Well, let’s get right into it. As you know, I’m going to ask you a series of four questions today and we’ll take about four minutes to dive into each one. Let’s start by having you tell us a bit more about yourself and your organization.
Mike: Sure. So, as you mentioned, I came to ONC in 2009 that was, if anybody can remember back that far, hopefully, you can. That was passage of the High Tech Act. So, ONC was quite small at the time but they had a new authorities and were looking for folks who can help with regulations and I happened to be one of those. So, I came on board then and been doing regulations, regulatory work for ONC since various policy work too, being working with FDA, OCR whether it’s patient access or you know, the proper regulatory environment for health IT and where there’s overlap and like I said, with FDA. So, I’ve definitely enjoyed my time here. It’s gone by really fast. You know, we’ve gotten through that quote, unquote ‘meaningful use stage’, and I think we’re at a new exciting place both for ONC and for the health care system with these new rulemakings that we’re doing, particularly ONC with our interoperability and information blocking proposed rule.
Dave: I couldn’t agree more. We are at an exciting time and we’re going to go much deeper on this question; information blocking in a minute but take a moment and just sort of generically describe to us ONC’s authority and how you go about doing the work that you’re responsible for?
Mike: Yeah, so, ONC’s main goal when it was founded and so forth, it was to improve the adoption and use of health information technology and hopefully through the use of that technology that health information would be available and accessible where it’s needed and when it matters most and that’s those for like care coordination and patient access but then as that initial purpose for ONC within that came through an executive order. Then as I mentioned, Congress passed the High Tech Act, gave more authority, felt that there was more need and push related to the adoption of health IT. So, ONC was given some authorities in that law, including the assumption of certification program to encourage the use of health IT mainly through, as I mentioned, meaningful use, also known VHR incentive program and now known as promoting interoperability. So, we as an agency focused on trying to make sure health IT had the functionalities in it, including interoperable capabilities to ensure that it could improve the efficiency care as well as the health in patients. So, that’s when we went about doing and then that took us through 2000 at least 2016 as a primary focus. There were many other activities we did as well, such as, you know, trying to establish the governance for health information and National Health Information infrastructure and then Cure’s Pass, right. The Cures Act, which gave ONC significantly more authorities, particularly as it relates to the certification program as well as I’ve been mentioning a few times if you’re not familiar with that word yet, information blocking. So, I think that’s clearly our focus today and when I say today, I mean for the agency but we’re also doing many other things and that goes back to this Cures Act Authority working within the department on activities to reduce burden, whether it be through the use of health IT or other activities within the department. We released a report on that and again, other programs that they’re kind of all interrelated. The trust exchange framework and common agreement related with this rulemaking and but being done outside of that through a separate channel and then the EHR reporting program also related to this rulemaking but again, a separate effort by us to implement congressional provisions.
Dave: The other thing that I have observed and I am certainly not an expert in this area is the role that task forces and public comment play in this and as I understand it, as part of this process, you organize a series of task forces. Now typically these are diverse subject matter experts. They kind of no at the problem and hopefully they grow up their way to a better set of recommendations or Solutions but then there’s also this idea of the public comment period that allows the broader public to digest what’s being proposed and respond to that and I know we’re in one of those public periods right now. So, my guests are always encouraged to correct me when I misspeak or misrepresent. Is that at least a fair summary of those aspects of the work?
Mike: Yeah. I mean, let me go back to the first thing that you mentioned which was a task force because if folks aren’t understanding, how did ONC set up some group of people to help them out with the rule? Actually, this goes again back to the High Tech Act. Congress set up what’s called a Federal Advisory Committee. They’ve actually set up two through the High Tech Act. One, that’s focused on health IT policy to give advice to the secretary and particularly to the national coordinator on policies related to health IT, implementation, use, functionality as well as to inform the EHR incentives program that CMS has overseen. With the Cure’s Act, I should stop there. There was one also on standards, right. So, there was a health IT standards committee and that they were even more designed to focus on the technical aspects that health IT should include. So, those two committees advised us up through the passage of the Cure’s Act and at that point in time Congress set up a new committee which is called the Health IT Advisory Committee, referred to as HITAC and that committee which takes on the same purpose really as those prior two committees combined with some more specificity that what Congress would like to see where they focus, including obviously interoperability. So, they are made up of appointed members both by Congress, by the Department and by the GAO, General Accounting Office and they are outside folks. So, your people in the industry, many of them with specialized as set out in the statute, specialized expertise, whether it be in public health, whether it be in representation of a provider or a patient perspective. So, those members are appointed and they make up our task force. So, there’s a broad committee and then when we’ve created a task force within them, So, certain members are focusing on different parts of our proposed rulemaking. We have a task force that’s focused just on information blocking. There’s another task force, it’s going to focus and has been focusing on just our conditions of certification. So, that applies to developers who bring products to get certified through our program and there’s another one on the particular standards of data that we want to see moved. That’s called the US Core Data for inoperability and then there’s a last one that focuses kind of on the broad care continuum, particularly our proposals related to pediatric care settings. So, we have four task force right now focused on this rulemaking to provide us very good subject matter expertise and input on the rule to supplement all those great comments we are going to get from the public during this comment period and we do this for many of our endeavors and be clear about that. So, like when we did the first draft of the trusted exchange framework, we had a task force to support that through our Federal Advisory Committee and we’ll probably do the same when that second draft, makes it to the street.
Dave: Well, that was a tour de force overview there and we will include some links to the website where there’s a lot more information about the different task force, about the schedule of meetings opportunity for public to listen to webinars and the like. I know we’re both itching to get to the meat of the conversation today. So, normally I would ask my guest, what’s the most important or interesting thing you’re working on right now, but I’m going to tell you it’s information blocking and so, if we could go right into that, the first thing I’d ask you is give us a simple definition of what information blocking is?
Mike: Yeah, so, the good thing is I don’t even have to come up with that simple definition because Congress did it. In the bottom line of it is, is really, it’s a practice. It’s any practice or activity that’s going to likely interfere with the access exchange or use of electronic health information. So, that practice, that interference could be just simply discouraging that information from being exchanged or an actual direct activity that would block that information like using tech to do it or business practice to do it. So, that’s it really in a nutshell is like, anything that’s going to prevent the use of access or exchange of health information, that’s information blocking.
Dave: And, my sense of the overall guiding vision here was that the assumption is the data should flow, that, that’s a key part of making our health system work better and of course, subject to the usual concerns about security and privacy and the like, and again, please correct me if I misunderstand this but what I’ve taken away from this at a very high level is that’s the default assumption that we should be exchanging data in a robust way and where we’re not doing that, we need to have really good reasons for why not. Am I oversimplifying or missing something here?
Mike: Not at all. It’s almost as you helped work on this rule with us or helped Congress write the statue. No, I think, we think that’s what Congress was thinking as well and just to give you a backstory and all that for folks who may not be aware, Congress asked us back in the end of 2014 to look at this issue of information blocking and asked us to write a report to them, which we did and we released that in and sent that to them in April 2015 talking about some of the things that we are seeing that were quote-unquote ‘information blocking’, and put forth a strategy of how to address it and Congress I think took a close look at that, kept talking with us, kept talking with stakeholders and I think they agree with you and I think everybody, I hope agrees is that the data should be able to move freely and we talk about this in the rule that you know, we don’t think that health information should be traded or sold just because you have it, right. A lot of that is legacy based in terms of the system was set up or healthcare provider in the area. They began to accumulate all that data, sometimes in proprietary formats and then there’s just no business reason they see to share it because that’s either going to, mean they’re going to lose potential customer in terms of a patient or open up more competition which is kind of the same thing but you’re giving either the patient the opportunity to make choice or you’re opening up the data to a competitor. So, that issue persisted right after the report and so, Congress felt it was a time, it was an identified market failure essentially and passed the law that said that shouldn’t be the case anymore and they really didn’t put any preclusions on it other than two, right. They said, unless the law says don’t share that information or if the secretaries define and that’s what this rulemaking does reasons not to share that information. Like if there was an activity that you did that, we thought was an appropriate reasons not to share the information, then you don’t share it. So, those are really the only two things Congress said when you shouldn’t share that information. Otherwise, I agree with you. I think Congress agrees with you and the department agrees with you that the information should be shared.
Dave: And, we’ll get a little deeper into some of those exceptions in a moment. You know, this is a question I have personally struggled with over 30 years in healthcare and where I’ve ended up and where I advise others. A good way to think about this data and these relationships is the way we think about financial trust. There’s a trustee and then there’s folks that manage the trust and it’s supposed to be for their benefit and I don’t mean that to sound paternalistic or patriarchal, it’s really not. It’s just recognizing that there’s a lot of data, there’s different people that have to come in contact and manage it. If we start with the mindset of, we are managing this for the benefit of the patient and that’s our quote-unquote ‘fiduciary responsibility’, I think we tend to arrive at better answers when we wrestle with these specific questions. So, I’ll get off the soapbox but to me, that aligns perfectly with this idea of, look, the data should flow for the benefit of patients and there may be clear exceptions to that and we should identify those but that should be our default. You said something else really interesting earlier and I do want to drill into this a little bit which is that information blocking can come in different forms and it can be technical or it can be behavioral but it can also be really obvious or really subtle and I think of those as sort of direct and active. I’m sorry, no, you can’t have the data, that’s so pretty direct kind of information blocking but you also alluded to what I think of is more subtle, a kind of indirect or passive-aggressive if you will. It’s typically the yes-but answer. So, yes you can have it but it’s going to cost an arm and a leg and I really won’t be able to get to your request for another 12 months which is yes, but in effect is no, and at the end of the day they all lead to what you described which is it’s likely to interfere with prevent or materially discourage access exchange or use of health information. So, if you agree with me or even if you don’t, yeah, talk a little bit about this idea of it can take many forms and what are some of the ones in particular that were concerned as the rules were created?
Mike: Right, so, I think with this statute, the 21st century Cure’s Act and with this rulemaking, it is a little bit different taking than what the market is now and just the market in general. I’m not just talking about the healthcare market. So, like I said, going back to Congress, they only said, if either with the Secretary determines a reasonable reason not to share it or unless a law says, don’t send person’s information for such and such reasons and you may find that sometimes in privacy laws there’s actually some of that in HIPAA but in the normal market, I don’t have to deal with you so to speak. So, you know, I could say, look, and I think you were kind of alluding to that a bit. Yeah, sure, I can give you whatever it is or sell you whatever but you’re going to pay $10,000 for it. So, do you still want it, right or you know, I just don’t feel like licensing my intellectual property to you. Alright, I think you’re a competitor and therefore I’m not going to do that either and that could be in any industry, right but in healthcare, if you allow that to perpetuate, right, then the data doesn’t move, right. So, it gets locked in and nobody else has access to it. There’s no competition, there’s no way to lower the cost of care or improve patients’ access and their health really by getting access to that information. So, taking all that together we said, these are one way that are used to keep from people having access to their health information, right or just another provider who use that information to help improve the care of that patient. So, whether it be developer A saying, sure, I can do an interface but it’ll be $25,000 for you and you don’t have $25,000 to set up that interface or they’re charging every time that information sent you a fee and when I’m saying these things, these are things we’ve actually heard and actually happened in the market. With this rulemaking, I want to try to emphasize, it’s been an evidenced-based approach. We’ve relied on observational information that we’ve seen hearing from countless stakeholders, meetings with the Office Inspector General and Stakeholders. So, those are some of the ways they do it. These as I also I mentioned a little actual property rights. So, they will say, they have a trade secret in the way that you just access the data, not in the actual data itself but just as a means of getting access to the data and then they’re not going to license it to you and you know, our interpretation of that is Congress didn’t say that was a reason not to share the data. They just said, unless the law said don’t share it, you don’t have to share it. So, we tried to strike a balance in this role related to both of those and I’m not sure if you want to get into that yet, but we understand the need for innovation and the need to get a return on investment for what you’re doing, right but we also understand Congress wants the data, to move and so do we. So, we tried to strike balance with the quote-unquote ‘exceptions’. So, those are those reasonable necessary activities where we’re gonna permit certain activities if it meets conditions where we think we’ll strike a balance in that case and let just talk just quickly about like intellectual property. So, how do we strike that balance? Congress didn’t say, okay, if you have some type of intellectual property writing, you don’t have to give that out or give access. So, be it. No, they didn’t say that but we said again to that innovation point is, look, we’re going to ask you to license that intellectual property so, there can be access to the data and we are asking because when we gave an exception, it said, you can license it but on reasonable and nondiscriminatory terms. So, therefore, you can make a profit, you can get a royalty on your innovation. So, we promote innovation. You can still go out, try to find a better way to do things and get a return on investment for that but you can’t use that as a reason once you’ve got it to let people not have access to the information. So, we’re asking if you want to take advantage of an exception, you need to license that on reasonable and nondiscriminatory terms. So, therefore, we think that strikes a balance where still promotes innovation, but it gives access to the information and it’s the same approach on recovering for costs reasonably incurred. We want you to be able to make a profit, get a return on your investment, but it’s got to be reasonable, it’s got to be nondiscriminatory and how you’re charging for that. You know, what we call an interoperability element use of it to get access to the data. I was kind of talking a lot there, it got me a little excited about talking the top about that. So, I’ll stop if you give any follow up on that.
Dave: Well, no, that was excellent and I mean it was really good because what we heard was, look, there are legitimate issues on both sides, you have to try to strike a balance that fundamentally and I read this as a kind of overarching theme in the combined proposal from CMS and ONC is it’s about promoting competition because that will lead to better and more rapid innovation. As to your comment about, believe it or not, these behaviors go on. Yeah, I think most of us in the industry are quite aware that those behaviors have gone on. This is definitely evidence-based and that these changes are needed and again an effort to strike a fair balance there. I do want to go a little further into the exceptions, but before we leave this idea of what kind of information is blocked, the obvious thing people think about is the data itself flowing and we focused on that but there’s another, I think really important aspect of this which is it also addresses information and discussions about the systems and their performance and again, the people might be surprised to hear this but there’s clearly a consensus at least in some parts of the industry that there have been industry practices, contractual and otherwise that have discouraged dissemination and discussion about critical information about usability, about safety, about untoward outcomes and the like, in effect a kind of gag clause in a way and as I read these proposed rules, they also address this kind of information and as someone, now it’s my turn to be passionate Mike because as someone who’s out of quality improvement and the patient safety movement, it’s very clear job. One is you have to talk about and measure these things or you will never really know what’s going on and you’ll never see real improvement. So, forgive me if I’m getting over excited here but I want to call that out and again, please correct me if I misunderstand it but the larger point being information blocking is not just about patient data flowing, it’s about the ability to look at these systems, discuss their performance, discuss issues related to their use and to do so in a way that’s fair and balanced and protected. Am I right on that or am I out in left field here?
Mike: Well, I think you’re talking about another part of our rule, right. I think everybody knows it’s a pretty big regulation that we put out and it’s kind of broken down into components and the one thing about information blocking kind of takes ONC out of its prior normal course of work, which was a certification program. So, we didn’t talk, we talked about what it is but who it applies to. We didn’t talk about that but information blocking that’s going to apply to all health care providers, you know, who meet the definition. It’s going to apply to developers of certified health IT to health information networks and health information exchanges. So, they’re all in scope on information blocking. Which you’re talking about is our bread and butter from before, right which is a certification program and so, Congress in its wisdom set out conditions of certification now in the Cure’s Act and so, this is getting at the behavior which is you were talking about of the developers. Before, just to give you like a comparison, the focus of the program was solely on the tech. So, did the tech do this, can the tech do that, right. Now it’s on the behavior of the developers. So, that brings in as you were talking to contracts, you know, the licensee, license or the contract or purchase agreement for that health IT, what’s in that now and is that being used to either stifle discussions of the product, right. So, that we have a, I think you were getting at our communications condition of certification which you know, Congress said, look, no more restricting certain stuff, discussion on the health IT. Particularly when it relates to like safety and I know that’s been in the news lately, right to safety of EHR’s or the security of it or the usability of it, all those various factors that would improve I think the health IT as well as care of patients by improving the health IT that was sometimes prevent it from being shared by what are known as gag clauses. Congress had hearings on this and I think it pretty much was concluded in and they had, were able to get the witnesses to say which included developers and so forth that those shouldn’t be in contracts. So, we want to make sure on the program, they’re not. So, we have provision that says and such like that type of information shall be able to be shared and we made clear when it came to IP while you can still protect your intellectual property rights when it comes to screenshots in particular. In most instances you should be able to share that if you’re a user of the health IT. Particularly when it comes to issues like security and safety and usability. We have a few provisions about how to make sure, you know, third-party IP as an exchange and that they’re not distorting screenshot that is the person who’s sharing it and personal and PHI protected health information is shared, things like that, that you know, obviously are important to everyone but generally speaking, the screenshot we think is fair use of the intellectual property and can be shared and we think that’s going to help improve, again, the health IT itself and then obviously subsequently the care of patients.
Dave: Well, again, a really good example of some of the issues and where you have to balance things and appreciate you clarifying. This piece is not directly part of information blocking its address in other aspects of the proposed rules. If you’ve just joined us, you’re listening to 4 x 4 health. We’re talking with Mike Lipinski, director of Regulatory Affairs Division for ONC. Mike, we were talking just a moment ago about exceptions. Let’s pick that up. As I understand it, there are seven exceptions. I’m not going to ask you to go through everyone in detail but give us a broad sense of why the exceptions were made. My impression is these are largely common sense things but tell us a little bit about the thinking behind those.
Mike: Yeah, you stole my words there at common sense. I think we hope that, that’s the way it comes across. So, that’s good to hear you say it. So, these are reasons why you wouldn’t share the information as we were talking about earlier and so, we focus on things like harm, you know, if it would cause harm to the patient or another person, physical harm, really, we’re talking about privacy, right or security, two more great examples, right. Why you may not share the information but I would just say on the privacy and security piece, again, it’s that balance going back to, right, where you have to make sure the intent is right there, right. So, it’s not used as a reason not to share the information. So, pretax in a legal sense. So, for example, on privacy HIPAA, you know, HIPAA is more a discretionary laws, particularly when it comes to privacy. So, the disclosure information can happen if certain conditions are met and a lot of times what we found, again through talking with stakeholders, complaints, as the department receives, the HHS Office for civil rights receives is that the information isn’t shared because some condition wasn’t met and there’s really no on a healthcare provider, there’s no onus to make sure that condition is, I mean, there’s definitely like onus to make sure the condition is met before they share the information but there is no onus on them to make sure somebody is taking steps to meet that condition. So, for example, the obvious one, if consent or authorization of the patient isn’t provided, it’s not accumbent necessarily under HIPAA for the healthcare provider to go out and make sure that happens, that there’s like a meaningful opportunity given to the patient to give that consent. So, in our role, we’re saying, we want to respect that, that these conditions need to be met but we want to see that you have policies in place on how you’re going to meet those conditions, how you’re going to provide a meaningful opportunity for a patient to consent or authorize to that, that you’re not going to discourage a patient from doing it. So, we’ve kind of said, look, it definitely aligns with HIPAA, our role, but we want to see you taking steps to share that information, not hiding. So, to speak behind laws that say, look, if something isn’t there, then you don’t share it. So, we just want to put more of an onus to make sure that information moves and if not to give us a strong, you know, justification under our proposed exception, why doesn’t. Same thing with security. We definitely, we all know, we’ve heard all the cases, right, where there’s breaches of information and even state actors going after health information and so, we definitely are proponents of strong security measures when it comes to health information. However, we don’t want to see that situation where we know, and this is a, you know, kind of a crazy example where your affiliate uses five-factor authentication it’ll say, right and that’s what you use, right. It isn’t for any particular identified security threat but you know, no one else in the area, it has the same capabilities or ability to do it. So, that’s the reason why you don’t share it. So, again, it’s getting back to pretext, like, are you really doing that to be discriminatory in your practice or is it actually for an identified security threat? So, we try it again. Strike a balance there where we definitely want to promote security and addressing identified security threats but we’d also don’t want to be used as a means to actually prevent the information being shared, particularly within a discriminatory way. So, it goes back to your organizational policies too. If you have policies in place, that’s a great start on how to make sure you know, you’re doing the right thing on privacy and security and sharing of health information.
Dave: Well, Lord knows we could do an entire podcast just on security, another one on privacy. We’re not going to do that today. I want to talk about enforcement and acts then. As I’ve always said, if telling people to do things work then my kids would have had straight A’s and their rooms would have been cleaned when they were growing up. So, there’s limits to just telling people to do stuff. Tell us a little bit about how these rules will be enforced and what you anticipate there.
Mike: Yeah, be glad to. Again, going back to the Cure’s Act, Congress actually identified, I’ll call them consequences for being found to be an information blocker. So, if you’re in health and you know, I would allude to, you know, who’s covered earlier. So, if you’re a health IT developer of certified health IT, health information network or a health information exchange, as those are defined in the rule and you can comment on that if you don’t think we have those definitions right. If you are found by the office of the Inspector General, so, that’s the HHS, Office of the Inspector General found that you are called like a prima facia case. I’m an attorney, so I think sometimes in legal terms and there’s certain elements that have to be met to be an info blocker. You have to have a knowledge. So, if you’re a health IT developer, it’s really, Congress says, you just should have known what you did, would likely interfere with the access exchanges, use of health information. So, if you’re found to have done that, Congress says, you are Subject to Civil Money Penalties up to one million dollars per violation and so that’s going to be up to the HHS Office of Inspector General to determine, one, if that entity is an info blocker and two, what’s the proper civil money penalty for them, what constitutes a violation and how much they should be fined for that. In an obeah process that OIG will use consistent with you know, how they approach all their civil money penalty cases, I suspect, I can’t speak for them but you know, it’ll go through that process in terms of final resolution. For healthcare providers the other group that’s covered, Congress left that to the Secretary of Health and Human Services to identify what are appropriate disincentives to prevent information blocking by healthcare providers or discouraged it at the least, right. So, we passed in our rule for comment on that. So, in the ONC rule on behalf of the department, we’re asking, are there already appropriate disincentives in place or are there additional incentives under say payment programs or through some other art meant agency whether it be, you know, FTA or OCR that any type of disincentives they can send in place for information blocking. In our rule, under our authority which is a certification program, we’re proposing that it is found and will have concurrent investigative authority with OIG when it comes to information blocking. If we find that a developer has information blocked, we would ban them from the program. That’s a recourse that we have available to us, you know, with authority over the program, obviously OIG cover holds a bigger hammer there with the money but it’s obviously that important that we should propose probably, you know, the, in our toolkit the strongest penalty in deterrent we have which is a banned from the program because I think again, going back to Congress and we still the same way, this is such a bad act that it should have a major consequence to it and then CMS for their part has put in their role publicly reporting requirements. So, if a clinician or hospital under their promoting interoperability program or to say they submit a no response as from an attestation perspective whether or not they info block that would be publicly reported. So, that’s where we are now but as I first mentioned the Department wants feedback, wants to use that feedback from the public to before we go through a process where we would have to through rulemaking proposed additional disincentives for healthcare providers.
Dave: Well, this is again, great overview of the various enforcement pieces. Substantial monetary fines are possible potentially having certified health IT decertify for public shaming through CMS, those are sort of combinations of carrots and sticks that hopefully will provide some real teeth behind this and of course I couldn’t agree more. This is one of the most important issues in healthcare today, certainly in healthcare IT and it demands this kind of enforcement, I think. The last thing I wanted to ask you about all this is and I think you’ve alluded to it is what’s next in the process and specifically, how could our listeners get involved if they want to provide feedback or can otherwise productively participate? Tell us about that part.
Mike: Sure, maybe I’ll take the interviewee liberty here and just try to also make another point like you know, try to maybe emphasize the why behind some of these too because you’ve alluded to it and I said, maybe we can bring it all back together a little bit here. You know, it’s not just about who has information creating innovation too, it’s freeing that data, like we talked about the patient getting the data, right. Well, it’s you know, who’s gonna help the patient get the data too, right. So, hopefully we are hoping a lot of, it was known as you know, our National Coordinator talks about the app economy, right. So, a lot of third party developers who can get that data but not just get that data for the patient but to provide that data to the patient in a better way, right. In a better understandable way so that it’s actionable for the patient too. So, such as getting them the data, right but it’s also getting that data out to see again like, population health, how to improve you know, seeing trends and things of that nature. So, we just think that’s gonna create competition as well as much as better care and that competition hopefully will lower the price of care too and on that point when we talk about what type of information needs to be shared. I think it’s important to mention in our rule. We talk about price information, right and we request comment on that and on behalf of the department we’re requesting feedback to talk about what type of price information can be made available that will help patients do better in both shopping for their care and lowering the costs they are paying for their care. So, I wanted to, I know we kind of talked in and out about some of that innovation competition pieces but I will kind of want to drive it back to what’s the bottom line that we think this rule can help support from administration’s goal and that’s you know, to lower the cost of care through giving patients control of their health information.
Dave: And, excuse me for interrupting, and to drive innovation and I’m glad you brought us back because it’s, you’ve taken us back to the top of the key if you will. It’s March Madness, so we’ll use a Basketball or, I see exactly what you described and I’ve written about this and I’m excited about it because my own belief is in the short run just getting the data to flow better is gonna pay big dividends but what we’re really doing for the longer term is we’re creating a new playing field that’s gonna spur innovation, allow us to innovate more broadly and more rapidly and we really need to do that and so I see these rules as also designed to spur that competition and create if you will a more productive field for competition and I hear some excitement in your voice about that out, I’m excited about it too. So, we’re in the sort of public comment stage right now and tell our listeners, if they want to comment, what should they do?
Mike: Yeah so, we try to make it easy for you in terms of if you came to our website, so it’s healthit.gov/nprm, we will direct you to where to comment through which is really regulations.gov but we have a plethora of resources for you. Past presentations we’ve given on the rule, including the PowerPoint Presentation, a recording of it, a lot of fact sheets but then you can click on a link right where you can, and it will take you to that regulations.gov, so you can submit your comment. We’ve also just released our public comment template. So, this is a resource tool, voluntary tool. It will help you organize your comments consistent with the way we’ve drafted the rulemaking. So, by topic areas for example or by criteria, you know, you can go right to the part about information blocking, maybe you have an issue with one of those exceptions or you have an idea that improve it. You can put your comment in right there, we’ll be able to find it easily too when you submit that comment. So, you can do all that and we’ve already got, I think it’s up to 190 comments and it’s exciting comments because we’re getting them in from individual patients, we’ll call them individual citizens, most of the comments are focusing on price transparency, very supportive of price transparency. So, it’s great to see the individual becoming involved in the rulemaking and that’s the point that I’m happy that you brought up and that I can emphasize so many times and this is good too because they represent their population but so many times it’s the associations who are submitting comments and whether it’s the association, the trade association for a hospital or a particular specialist society or health IT developers. You know, those comments are great too, don’t get me wrong. Like, they are important comment, they represent the industry, the concern of the industry as well but it’s great to see patient involvement so early in citizen involvement and I wanna encourage that and they can do that through like I said, through regulations.gov or they can come to our website, healthit.gov/nprm and you can use those resources and even comment directly through a link there on the rule. So, we wanna definitely encourage that.
Dave: Well, and I do too and we will also provide those links on our website, so folks can get to those. This has really been terrific Mike and I wanna thank you not just for coming on the podcast today but for the work that you and the folks at ONC and CMS have been doing on this. Our Federal Government, it’s popular to bash the Federal Government, I’ve certainly done my share of it too but my experience and my impressions from having followed this very closely while having worked with the Office of National Coordinator is these are good folks with very well-intended have worked very hard on what are some obviously very complicated issues and how you have to balance a lot of competing interests and it’s never perfect but I think you guys have produced just some tremendous work and you’re filling a real important need because it’s pretty clear my industry healthcare was not gonna get this solved on it’s own that it needed some quote-unquote ‘outside help’ and so again, I wanna thank you, I wanna thank the team, Dr. Rucker at ONC and others for what has really been I think terrific public service and no doubt we’ll wrangle over the details and we’ll try it and we’ll have to adjust and go forward but this feels like a really important and productive step forward. So, my apologies for the speech here at the end but I want it to be clear about that part of it.
Mike: Well, thank you so much. It’s comforting to hear that. I think as you’ve alluded to, we put a lot of effort into it and sometimes I want you to try to open that up and make it transparent, the process. You know, getting to a, what essentially is the law at the end, right, a regulation that regulated community has to follow and I know there was some concern of like how long it was taking, we heard that but we wanted to make sure we put our best foot forward with this proposed rule and we went through a lot of process of looking at what evidence was out there, you know, studies that have been done and citing to those studies, interacting with stakeholders, stakeholder groups talking to other Federal Agencies that have expertise, hiring folks with expertise and you know, listening and this is the next part of that, right. What we have right now, right. This is such an integral part to the whole process, which is a comment period and hearing, okay, so now that you took all that information, put forth opposed way to address that market problem, right. Is this the right way, right? So, tell us if it is or it isn’t, tell us what we missed, you know, what we might be forgetting or unintended consequences or you know, consequences you don’t agree with. This is such an important part, it’s, you know, there’s still another about five weeks left to get your comments in on that. So, we’re looking to hear that and then what we do next is we go over every one of those comments and we review them. We’re still reviewing some of the same comments, is there a you know, a theme, a concern in terms of a theme and we review all that and then you know, we look at our policies and what we want to achieve and then we come forth through the regulatory process in the Government too where it’s reviewed, you know, throughout the department and through the Government before it comes out as a final rule. So, that’s what we’ll be doing after May and actually now I, like I said I, we’re already looking those comments to come in. So, please keep them coming.
Dave: Well, and I’ll just echo that. This is the time for folks to engage and help, shape these final rules because I said, no doubt we’ll go try these for a while, we’ll learn some things that we didn’t expect and we’ll adjust accordingly but at some point, we just need to proceed with those experiments and hopefully sooner rather than later. We’ve been talking with Mike Lipinski, Director of the Regulatory Affairs Division for ONC. Mike, thanks so much for joining us today and providing just a terrific overview of the issues related to information blocking.
Mike: Thanks for having me.
Dave: You’ve been listening to 4 x 4 Health, sponsored by Sansoro Health. Sansoro Health, integration at the speed of innovation. Check them out at www.sansorohealth.com. I hope you’ll join us next time for another 4 x 4 discussion with healthcare innovators. Until then, I’m your host Dr. Dave Levin, thanks for listening.
Director of Regulatory Affairs Division within the Office of the National Coordinator for Health Information Technology (ONC)
Michael leads ONC’s development of regulations and contributes to HHS policies, regulations, and initiatives that support the U.S. heath care system.
Michael Lipinski is the Director of the Regulatory Affairs Division within the Office of the National Coordinator for Health Information Technology (ONC). Michael leads ONC’s development of regulations and contributes to HHS policies, regulations, and initiatives that support the U.S. heath care system through the adoption and use of health IT, electronic health information exchange, and patients’ access to their health information. Before coming to ONC, Michael served as the Senior Legal Advisor to the head of the HHS Office of Medicare Hearings and Appeals. As the Senior Legal Advisor, he played an integral role in establishing the Office and provided procedural and substantive guidance on Medicare to the Office’s administrative law judges and staff.
Michael received his law degree from Georgetown University Law Center. While in law school, Michael completed a judicial externship with the Honorable Alice M. Batchelder of the United States Court of Appeals for the Sixth Circuit and an internship with the Center for Sustainable Health Outreach.
Chief Medical Officer
David Levin, MD is a physician executive with over 25 years of experience in healthcare information systems, clinical operations and enterprise strategic planning.