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ONC info-blocking rules
April 17, 2020

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.

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Originally published April 17, 2020, by Integrative Healthcare Executive.