Experts Break Down Industry Implications of ONC Info-Blocking Rules

John D'Amore from Diameter Health and Matthew Michela from Life Image sit down to discuss how the ONC info-blocking rules impact health systems and provide tips for executives navigating these new rules.

Podcast Transcript:

Welcome back to "Pop Health Perspectives," a conversation with the Population Health Learning Network where we combine expert commentary and exclusive insight into key issues in population health management and more.

Today, we are joined by John D'Amore from Diameter Health and Matthew Michela from Life Image.

John D'Amore:  Hello. This is John D'Amore from Diameter Health. Thanks so much for having us here today for it. Really excited to join Matt from Life Image as well.

My quick background, I serve as President and Chief Strategy Officer. I've been deeply involved with interoperability on publishing things in the peer review domain. I'm an editor on HL7 standards around how they take out data from EHRs today and really excited to speak on this topic.

Matthew Michela:  Thanks, John. Thanks for meeting with us today. This is Matt Michela. I'm the President and CEO of Life Image. Life Image is the world's largest evidence-based network for provisioning access and governing medical information and data between hospitals and across many other types of organizations. Our core company and our entire technology is built on interoperability and is focused and based on that.

John:  For the information blocking rules, there were two major rules that dropped in early March that were meant to be part of HIMSS. There's the ONC rule and also the CMS rule.

There's a spanning effect in terms of those two rules, one affecting a lot of how health IT products work and how EHRs operate and how providers use those. The CMS rules also deal with how payers make that data accessible to their members.

I think that there are some big themes from the rules. I'll speak first on some of the CMS ones and let Matt fill in on some of the ONC ones.

The CMS rules require, beginning in 2021, that members be able to access their claims, their cost, and also their clinical data that is maintained by payers and health plans, specifically Medicare Advantage and Managed Medicaid but expecting this to span across also the commercial plans as well.

That access to information that would be downloadable using the new FHIR, or Fast Healthcare Interoperability Resources, to one's phone or one's computer is really going to liberate and speed data access for members and really open up whole new channels by which they can acquire their historical records as well as a lot of those clinical records.

The clinical records are going to use some of the standards from the US Core Data for Interoperability that were really elaborated in the ONC rule. I'll hand it to Matt to talk a little bit about that.

Matthew:  Thanks, John.

The ONC rules determine not just compliance with the FHIR standards across the board and are predominantly focused on delivery systems, hospitals, providers, etc., but dictate what really are the minimum data requirements that have to be transferred, which include things that people are starting to do now just in the natural course of business of data that might be sitting in a structured way inside the EHR.

Also, importantly, what those rules also dictate is that clinical information is actually included here. That clinical information's first wave tends to be things that, again, are achievable to reach in a technical form of PDFs or GIFs or other kinds of imaging that is focused on clinical narratives, which is fundamentally important.

The structure of the rules and the utilization of FHIR is really, really important to provide access to patients and others with the proper rights and consents and responsibility to have access to medical information in a way that's tremendously meaningful.

The addition of the clinical side of the house, so to speak, and that data is actually what in the long run is going to drive cost and quality, not just what, as John was suggesting, a claim is that gets paid or how much it is.

That's fundamentally important and really important for consumers and payers, but it also will describe the clinical information coming out of one of the areas that we focus on in particular, imaging as an example, so that it's not a set of information of, "Hey, I just had a CT exam," but actually being able to then access the information of what did the exam say, what was the diagnosis, if there was a tumor, what type of tumor, what stage of cancer, what size.

That information, which ultimately is very, very hard in today's world for consumers to access, is now a part of that minimum data standard.

As John had mentioned, it’s very exciting for a foundational system in place, that across the entire health care ecosystem will decrease abrasion and accelerate access to data that's going to light up a whole future here of innovation.

John:  From the CMS rules in terms of the benefits that will come out of that, first is beginning in 2021 members will be able to access their records, their claims, their encounter information, their cost, including what the payer paid as well as what their copays and what their deductibles were for it, as well as any clinical information that's maintained by the payers.

Payers have actually begun to maintain a large wealth of clinical data over the past several years as they use that data for a whole wealth of purposes for population health, predictive analytics, care management, risk adjustment, and also quality reporting.

Having access to that data in a computable format on a patient's phone or on a member's laptop is really just going to lock, as Matt said, some of that tremendous innovation of the industry.

One of the big things here is it's also going to provide a more longitudinal view of this information as a benefit to a member. Sometimes when you go onto one specific health system, one specific record from an office or an ambulatory practice, you get a piece of the puzzle for it.

Being able to stitch that data together both from providers as well as the health plan perspective allows you to get a much more longitudinal view of that.

Really, starting in 2022 as part of these rules, payers will need to exchange this data with other health plans and other payers, which I think is just a tremendous step forward in terms of having that continuity of data flow.

You don't have to be looking at new members as being a black hole where you don't know information about those members. You can really use a past precedent that's been collected over that lifetime of that patient's chart and claims history.

Matthew:  Building on that, what John had said, when you ask the major benefit on a very large strategic level, what is the ONC, CMS, HHS, and Congress ultimately trying to do here? It's unlocking all of this data around patients that today results in significant injury to patients and cost to the system.

Whether it's because I don't have the results of a test that has to be done a second time or I don't have the results of a test that would influence what drug would be most effective in a chemo treatment or I don't have a good sense of what drugs I've taken and, therefore, I take a drug that is a contraindication and causes harm or death those things are real life and happen across the entire system.

The foundational change this puts in place across the system is to resolve that eventually. They've gone far enough to determine what a standard technology should be, because all health care IT has historically been built for single use cases or by manufacturers or with deliberate intent to block data for commercial benefit for the health care organization itself.

This foundation has the ability to change everything. Right now, we should understand that this is the foundation, and it will, over the years, continue to get refined. The data standards that were initially defined here are, from our perspective, we're very pleased, because it was not the minimum required care.

It was the foundation across clinical and financial data that ultimately is really required and sets in place a technology standard so that smaller companies' innovation, companies focused on innovation, companies focused on solving problems that sometimes these very large healthcare IT companies are not interested in devoting resources to solve, ultimately can be.

Ultimately here, in order for this to work, there has to be not just the setting of the rules and then the standards and the standardized technological approach, but also there has to be some enforcement to it, because as a healthcare industry, we do tend to, and I think we've got decades of experience, sometimes slow-walk change or find lots of reasons and rationale for not doing the maximum amount possible to be transparent with patients and data and payers, and folks who reimburse care.

Having that enforcement arm in the end to keep this thing progressing forward beyond what's already been dictated in '21 and '22 and '23 is going to be important. To your fundamental question, Julie, right people have said, data is really oil for health care, here it's essential.

It makes everything run, and accelerating the ability to access that data and combine it from data that sits in other systems and other hospitals and other payers in itself will be just transformative.

John:  So I’m thinking about the rule's impact on the health care industry as really being, I think, two major pillars. One, it's really going to set the bar for data access, both to members, to patients, as well as to other recipients of that data.

A large portion of the rules of both the CMS and ONC work to define what is information blocking and to taking down the barriers to information exchange for them.

Historically, there have been things like cost and prices associated with extracting medical information. The rules do a good job at taking those down to essentially zero for a patient and basing it much more on costs onto that data access, generally. Being able to get that information flowing is, I think, a major impact of the rules for the health care industry.

The second pillar that I think is going to be truly influential is being able to consolidate on one standard for interoperability. The rules, both on the CMS and the ONC side of things, use what's called R4, which is the most recent version of FHIR. It was released in 2019, and it's gone normative, meaning that it's reached a maturity level for a standard that's ready for widespread adoption.

Having information in a standards based format and having all these different participants, not just the EHR, but other health IT vendors, and having smartphones and computers be able to use the same standard for changing information is going to be liberating, and it's going to provide a clear focus for the delivery.

What comes next after this will be a lot of how do we make that information, as Matt alluded to, as useful as possible? How do we synthesize that information? How do we normalize it, consolidate it, be able to make those longitudinal views of patients and be able to use that information to come up with better predictors of disease progression, predictors of risk, and doing the scanning and surveillance that we want to be able to do with health data but has largely been impeded by an inability to access that data and an inability to have standards in health care for the past decade.

Matthew:  Thanks, John, well said. I would add to that two points. One is the establishment of the healthcare technical standards is fundamentally important.

I'll talk about standards specific to medical imaging. There is a standard that's created that's called the DICOM standard that's been in place now for a couple of decades. Every manufacturer and everybody who takes a diagnostic picture inside the body conforms to this standard.

Having said that, dealing with every type of medical imaging and every manufacturer on the planet, what I would tell you is that a great number of those manufacturers conform to the standard but do something slightly nonstandard to it, and for a good basis reason within their own technology stack, which then creates interoperability problems.

Part of what the rules do here, and to get to your original question of what does it mean to the industry overall, the creation of the standard is fundamentally important. The requirement, beyond the standard, to make that data accessible is the missing piece.

If enforced with some reasonable penalties and consumer demands, the rules will force many of us in the healthcare IT field to make sure that we comply with the standard in its full integrity, especially as we look out over time. To your broader question of what it means for the industry, I will say to you that I think this has the potential of saving most of the healthcare IT industry that exists today.

So much of our industry has been created on, in some way or the other, finding unique, proprietary solutions that are driven by the data that we've got access to, to demonstrate value. If you look at what's happening in technology across the industry, there is such an amazing movement of data in other industries, this has already occurred in health care, to the cloud.

You start putting data into and running operations on Amazon, on Microsoft, on Google, etc. Those environments talk to each other and have such an ability to drive performance and to innovate.

What's going to happen here is, whether these large healthcare IT companies, the big EHR companies, the big manufacturers, the imaging companies, the GEs, the companies running large claims systems, or voice systems for health care, etc., once that data starts to go to the cloud, it will be standardized and it will be interoperable.

If our industry doesn't do this and we don't take it seriously, I would predict we could look ahead 5 years to 10 years from now, all that data is going to sit in the cloud anyway. Then it's going to be non-healthcare companies that are delivering these solutions directly to consumers.

While many in the industry look at these things today and think of them as a technical burden and a resource burden, and something they hope to delay or forestall, I recognize the complexities. This gives them an opportunity to create future state products while they are still relevant in the marketplace with consumers and providers, etc., as opposed to becoming obsolete because they're holding on to data and slow-walking administration of these things.

It might have to get a bit, eventually, explosive here, but I think many of these healthcare IT companies that have been around for decades and that people consider to be the gold standard, if they don't embrace this quickly, they may not be here in a decade.

This gives them a chance. It forces them to get started in serious ways that, hopefully, they'll embrace and adapt.

John:  I think that these rules make a marked advancement for interoperability. The standard that they picked in the rules, both the CMS and ONC, is a real clear winner, and that's the FHIR R4 version. That interoperability standard is not just a content standard.

It doesn't just say how the data should be structured, but it also dictates how that information should be transported, which is using APIs, or application programming interfaces.

Building off what Matt said, this is going to unleash a lot of opportunity to be able to have large companies  and large companies are very interested in this  being able to take data to Microsoft, to Google, to Amazon, as well as small companies.

Myriad startups, nationally, being able to use these standard to be able to pull data back -- APIs, or application programming interfaces, are the fundamental transaction format for all information on the Internet and the Web. Being able to have that information, share and liberate it using the FHIR standard, is a major step forward.

Very excited for how this is going to improve interoperability and fundamentally, giving patients access to that information is going to allow patients to be able to see that information, to operate on that information, to be able to correct that information often enough.

While health plans may provide that information that they receive, there may not necessarily be a requirement for them to go back and inform the clinicians or inform the providers when they need to improve interoperability or improve some miscoded piece of information.

Giving the patient access to see that data and see where it's from is going to allow them to take a new level of involvement and engagement with their medical records to be able to see that it represents true and accurate information that we know about their care and they know about their conditions.

Matthew:  Adding to that, the aspect that I would focus on is the access to patient data. John did a perfect job describing the technical aspects of lubricating that and making it happen. I would reflect on the current state today. If you go back and you look at HIPAA, which has been in place for a very long period of time, it was very clear on patient data access rights.

Patients have the ability to go to the institutions, the providers, and ask for their data. I'll focus on the provider side. Now I can go and I can ask. However, as this has so often developed over time, the data that can be provided can be determined by the provider themselves, and the mechanism, which means I might have to fill out 27 consent forms and, in some states, I might have to pay for it.

I may have to fill out the forms four times, and I may have to do it in person. We create these workflow and logistical barriers for patients to collect the data.

That's not necessarily a technology challenge but it’s done in many regards because that's the way we've always done it or from a regulatory point of view. I'm going to give you your imaging on a disk, but what I'm not going to give you is the radiology report from the initial read that sits inside my system.

God forbid it wasn't dictated appropriately enough and it shows up in a legal lawsuit later as a revised report based on further information. I'm just not giving that to you. You don't need it. Move on.

What these rules do, once we lubricate the technology side, and they've established a minimum standard for information, which includes not just the easy-to-get-to discrete data, but allows, as John had mentioned, a longitudinal, historical look even at these first generation data requirements.

It will not be the last. They will continue to put new rules and new standards in over time, and say, "Now that we've gotten that accomplished, what's the next level data, the next level data, the next level data here?"

Then we've had patients getting the data that they're legally entitled to now under HIPAA, by taking away the guesswork from providers and taking away the nonstandard approaches that providers use, inadvertently I'll give them the benefit of the doubt, in order to share data with them.

It ups the requirement and, on the back end, starts to create a structure for regulatory compliance and financial penalties if you don't provide it.

What we've learned, historically, is the regulation is one thing, but it wasn't enough. Now, with these rules, with ONC and with CMS, what they've said is, "Now we're going to create a standard to ease the technology and get rid of a lot of those excuses for doing it. Now we're going to increase the emphasis on the right of access itself, that this isn't yours to decide what information to provide." It says, "This is the information you must provide here," and that's going to get more standard over time.

Now, on the back end, we're going to see relatively soon penalties and enforcement that say, "If you don't do it, there's consequences."

That entire end to end system here is what the ONC is really smart in putting in place, that I think, ultimately, is going to move us significantly farther ahead in this goal of recognizing that patients really do own their own information in a broad context. They will do with it what they want.

Over time, this changes the complete power balance here between the people who hold the data hostage and the folks that actually should own the data themselves: patients.

John:  For health care executives, and particularly health plans, I think that these rules place an incredible onus, an incredible burden on them to get onto the new standards for medical data and for claims information using FHIR because there's only nine months.

That is going to be an incredibly short time span for them to be able to start providing this information through endpoints that members can access that information. I think that's incredibly accelerated. If you're not already working with technology vendors, working with ways to be able to access this data on FHIR, you're definitely behind schedule for it.

For health systems, there's a little bit of a larger window that's provided here. The twoyear time frame on the ONC rule for adoption is going to allow for EHRs to go through a new certification process to be able to put this in place. They're looking at 2022 and 2023 in terms of having that data available and accessible.

One thing, building off of what Matt said, is that these rules also introduce a process that won't be static over time. It has something called SVAP, or Standards Version Advancement Process. Essentially, they'll be able to follow the industry as new things are required to be included and shared among patients, among health plans, among health systems, for medical information in the future.

There's a requirement for both health plans and for health systems to be uptodate on these rules and to be very engaged with the technology vendors. I don't think, for health plans, that this would be something that they can just build themselves. They should be looking to people who've already begun work on this and demonstrated capabilities through industry collaborations.

Matthew:  The advice I would give, in some regards, is a little bit less specific. I would say, number one, hurry up. This is an opportunity to organize your organizations and bring them into the future.

I would predict that those that embrace this seriously, and they look to say not, "What is the minimum amount that I need to do in order to stay out of regulatory trouble?" but, "What is the max amount where I see this thing going" and, "Let me make sure that I'm driving towards that goal." Those are going to be the organizations that will be more relevant in the future.

I would argue that those that don't embrace and don't move quickly healthcare changes slowly, so they'll be here for a while  they're going to struggle. Eventually, I think their viability is in question. Rule number one, take it seriously and hurry up. Agreeing with what John said, I think most of the health care organizations and entities can't do this themselves.

Again, part of it is they manage different businesses, others, they manage historical technical stacks. We talk about, if I focus exclusively on health systems, very, very little of what they do is on the cloud.

It's all inside their own protected environments and architecture. They're filled with dozens, hundreds, and thousands of really, really skilled people who understand that technology really well.

If you want to accelerate, all the companies that are building new solutions and new software and new approaches, they are operating in the cloud and they will work 10 to 100 times faster, so there's a skill gap and a problem here. That requires  an approach John had just mentioned: go to experts, go to folks on the outside that are doing it.

The other thing I would suggest that they think about from a vendor selection point-of-view is one of the first questions they have to ask, “Is this a vendor that I'm working with?” Irrespective of what product and solution they offer, irrespective of how large they are or how much you purchased from in the past, you need to look at those vendors and say, "Is your fundamental business model built around public standards, available standards, and interoperability, or has it been built on proprietary systems with proprietary integrated technical stacks that hold data captive and I can add you certainly more value in the short run, because I now can deliver that faster?"

. Companies that have business models like that on hand are really going to be one, so it's hard for them to deliver these noninteroperable solutions over time.

It's very hard to take a multibillion dollar company that has built a global, in some cases, technical footprint by not creating APIs and not integrating with other people and not operate on a cloud and then say, "OK, now you're going to reset my entire technology future in order to get there."

If I'm making vendor choices and looking at it, that's my fundamental first question, "Are you a long-term strategic partner that is really going to help me get to this end goal? Or are you somebody that is going to create great solutions, and maybe from a technology point-of-view brilliant, but nevertheless, isn't going to get there as fast and isn't going to innovate as fast?"

If you asked healthcare IT executives, they know the difference between these two kinds of organizations. It's very important to look forward as to who they're ultimately going to be working with and partnering.

It will be the companies, I will argue. Again, technology moves so fast. This domain is now going to accelerate because of these new interoperability rules. The world will be so different in 5 to 10 years as this accelerates now.

Companies that take three years or four years to change their mindset and decide to create their first APIs with historical customers are not going to be the winners here. They're going to be the ones that get in the way, not advancing the solution, so be careful about that would be the advice I would give them.

John:  One of the things that I'm most excited about is being done reading 1,700 pages of the regulation.

Matthew:  [laughs]

John:  You would agree. It was certainly a very lengthy exercise. I'm really excited to see that both of the rules came out at the same time because it provides unprecedented alignment between CMS and ONC  ONC being the Office of National Coordinator for Health IT and CMS being the Center for Medicare and Medicaid Services  really having a lot of the regulation around health plans.

I think having both plans and health systems aligned in terms of the timing of how this information is going to be using new standards and having them both be driving towards the same goal of using the same standard FHIR R4 for accessing that information, truly exciting for it.

I've had a chance to write up a lot of these findings in a four part blog post on Diameter Health's website and really encourage people to look into this. I think that this is really exciting for all of us as being patients as well.

We all pay for our health plans, either through employers or directly for it. We all receive health care. Being able to access this data in a much more interoperable format is a true advancement for the industry, so I'm very excited for what the future looks like.

Matthew:  I'm very excited also. The way I think about this is, 35 years ago when I started in healthcare, I was arguing and writing and talking about interoperability at that point and what it meant for the system that we were developing managed care and other models, etc.

Five years after that, we were writing about interoperability. Five years after that, we were talking about interoperability. It's been decades and decades of us basically all saying this really needs to happen and everybody in the industry agreeing.

Unfortunately, I kept some of those speeches and presentations and look back and it's almost the same words we were using three years ago, which is, in some measure, really demoralizing. Having said that, I am no longer demoralized.

What the ONC has done here and, in a complimentary fashion with CMS and under the direction of HHS and Congress, they have put the foundation to absolutely make all of the things in the industry that we've been talking about here around interoperability and access to data involvement and patients and patient engagement and education and choice for patients, the things that drive cost and quality and increased satisfaction at scale. They have finally put in place the foundation for that.

It's not just the rule part, but it's as we discussed a little earlier, it's the rules with the standards, with the demand for access, which will be compliance requirements and then enforcement with an iterative process to make them relevant over time.

I've never seen anything like this foundation in my three and a half decades in health care and so I cannot be more excited about the next phase here and looking forward to playing in the industry for that.

I'm going to pay particular attention over the course of the next year to 18 months around whether there is enforcement, whether there are penalties for people that are blocking data, whether we're serious about that.

If we're not, then I think we run the danger of the industry slow-walking this, and having lots of reasons to slow-walk it that all the time will appear rational, or whether they actually understand it must happen and embrace it.

I'm looking for those test cases. I'm looking for those penalties. I'm looking for the compliance regulations that are coming out here next to then validate my optimism for this change, but I believe it has the ability to change everything.

Health care is not transportation. We're not rebuilding Uber in health care here, but the same fundamental value drivers that “I'm a consumer that knows what I want to do and when I want to leave and who I want to drive it and what kind of care I want”  all those fundamentals about human existence and our choices we make can be unleashed in health care. That's very exciting.

John:  One thing, in conclusion, in terms of thinking about the availability and accessibility of health information is certainly very relevant for the current circumstances with the recent outbreak of coronavirus worldwide and in the United States for it  there's an increasing appreciation that we need to have health information flow to where it's needed most for it.

This rule really sets a lot of those standards up on a goforward basis. I think that knowledge is power in terms of where health care operates. Fundamentally, physicians, caregivers, clinicians need the most relevant and the most timely information to make the right actions for a particular patient.

Health information exchanges can become all the more relevant as patients go to different providers and may be cared for in different health systems in the current crisis.

I think that this rule is timely, I think it's important, and I think that we're going to see continued movement along this accessibility and availability of health information across a wide spectrum of payers and health plans. I do think that it's quite important for future resources, or to learn more for this.

You can certainly go to our website of diameterhealth.com and also reach out to us via LinkedIn or Twitter. My Twitter handle is @jddamore, and we also have a Twitter handle for Diameter Health.

I really encourage people to look there. We've done a lot of work to digest, to understand, and to piece apart these rules, and we can also demo our capabilities of using these new standards, such as FHIR R4 for providing access to that information.

Matthew:  Thanks, John. That's really useful.

I think that in summary, from Life Image's perspective here, and mine, as I know we really were incredibly excited about these changes, we are tepidly optimistic we'll see regulators enforce these so that we can prevent what I think is a very, very exciting process and structure for determining ultimately data transparency across the system happen quickly, as opposed to slowly here. I'm really interested in seeing what the next phase is here.

Thank you again for your interest and your time.