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ONC's Rucker says proposed regs will give patients power over their healthcare


ORLANDO, Fla.—In two long-anticipated rules, the CMS and the Office of the National Coordinator for Health Information Technology Monday released two proposed rules aimed at preventing data-blocking and improving interoperability. The rules require organizations to implement open data-sharing technology to ensure data can move from one plan to another, potentially by way of patient apps. The agencies also released two requests for information on promoting interoperability and reducing any burden on providers regarding health IT. The proposals mean the names of providers who block patient information will be made public.

Modern Healthcare Editor Aurora Aguilar spoke with Dr. Donald Rucker, the national coordinator for health IT, at HIMSS2019 in Orlando shortly after the government’s announcement. They spoke about the proposed rule and its implications for providers, payers and vendors. The following is an edited transcript of that conversation.

MH: What kind of reaction have you received so far?

Rucker: ONC’s rule is 700 pages, the CMS’ rule is 200 pages. Maybe people should read it before they have an opinion, maybe I’m old-fashioned that way. Frankly, we’ve been on the public stage talking about the outlines of what we’re going to do, certainly the entire time I’ve been at ONC, almost two years now. We try to do it in a way that’s not a surprise because a large part of doing this is just coordinating, letting people know so there’s a real win.

MH: Is the stick the way to go to get interoperability moving?

Rucker: The civil and monetary penalties in the 21st Century Cures Act related to data-blocking potentially fall on vendors, networks and exchanges. The fourth is providers; the provider penalties is a work in progress within HHS.

Now from my view, the providers already face penalties on information-blocking because in order to get paid by the CMS, they must prove they’re not blocking information.

The CMS is looking at the client’s data. Our focus is on the clinical data. Interestingly enough, it’s actually very hard for payers to get electronic clinical data. They get the claims through the whole claims-processing mechanism, but if you pick your large payer it’s actually very hard and expensive to get clinical data, and the charges can be $5 per chart.

As part of the advance of FHIR, we were working with a number of payers to build a population-level query. Historically these queries in FHIR were designed for one patient, but if you want to do population health, if you want to do the very powerful economic thing of deciding should I contract with provider A, have provider A in network or provider B in network, there’s very little computational data available on that and we need that.

MH: You’re talking about data that would inform outcomes or value, correct?

Rucker: Yes. Our whole mechanism of thinking about value in American healthcare now are these very narrowly curated value networks or value metrics. For example, give me eight value measures. With these solutions ONC is proposing, electronic health records have way more data than just those narrow quality measures in them.

MH: Will working to meet these requirements cost any provider more?

Rucker: The Cures’ Act set a few provisions on charges. Patients get their data as part of the care they’ve paid for. For example, let’s say you use Apple Health or some other app that says, “I’m going to collect all of your provider’s data for you.” That app cannot be charged by the provider to get the data.

The EMR developers are only allowed to charge costs reasonably incurred and that includes the cost of capital and the fully loaded cost of engineering. But this can’t be some massive profit raking operation because Congress has forbidden it.

We’re trying to keep fundamental computer engineering work to a minimum on this initial go-round, focusing on read-only data as opposed to read and write.

With read-only data in a worst case scenario, all you have to do is place a query out to your API and reformat a query. That’s not hard in these databases, that’s what the databases were designed to do. That’s saying, “I’m going to drive my car down the road.”

Now, if you have write, then you’re going deep into the software in a way that was almost certainly never anticipated. Because then you’re making function calls into the software for all kinds of stuff that it may not have been engineered to do. So from a technical point of view, we have a relative lift here but it’s quite doable.

That’s the cost question, that’s the technical work that needs to be done. One of the things that we’ve repetitively heard is, “Oh the vendors are charging us a million dollars for an API.” In order to meet the congressional language regarding application programming interfacing without special effort, you actually have to do something about the charges.

The bottom line is that folks have to be reasonable about what they do. Now, if there’s a value add, if you’re highlighting an app in an app store as a vendor, you can charge extra for that.

MH: Do you think this is going solve the problem of interoperability?

Rucker: I am very excited. Over time, I think this will—combined with the modern app economy and the tools that are available, the bandwidth that’s available—materially change the way care is delivered and the way patients are empowered. And frankly we’ve designed this to allow new business models and new forms of competition into the American healthcare space.

That was the intent of Congress. President Barack Obama, certainly President Donald Trump and HHS Secretary Alex Azar, (their intent) is to have people have the power to shop, to control their care, and to have new options in care, new business models. Look at your smartphone and there’s page after page after page of apps.

But there is no Uber or Lyft in healthcare. There’s nothing really like a robust banking application or an aggregator site for healthcare.

And there just hasn’t been really entrepreneurial activity in this space because people haven’t had any access to the data. And what data has been accessed is very, very guarded, very proprietary and I think we’re gonna see new business models here. I think patients have not been empowered in the American healthcare system frankly, since the start of Medicare. This is a way to get patients back into the game.

MH: Recent history (CMS’ requirement that hospital post charges) shows organizations can interpret these rules differently. How will this actually empower patients?

Rucker: The key part of this is we’re using standards to do these APIs. The problem with the chargemaster is there’s no format for chargemaster display. You can put it out there in any which way you want.

We also have an request for information in the rule for informational price transparency. The challenge is right now, there is no computer science, computable programmable definition of what price is or how you would even do it. All of that is still a work in progress.

I’m optimistic as we free up the clinical data, clinical transparency, some of the price transparency stuff will start coming along as well. It’s a little known fact in American healthcare, but markets do actually work. And I think this will happen and certainly from the administration’s point of view we are looking under every rock to try to figure out how to represent price information.

MH: How much do we need to worry about security issues with this push for interoperability?

Rucker: Anybody who’s doing computing in the modern world you have to worry about it, right? What we’re doing is we are very consciously working to make sure that the best security practices of the entire software industry come into healthcare.

We do not want to tie healthcare to a point in time that somebody else can then hack in. We want everything done in a way so that the best security can be incorporated.

Ultimately if patients download their medical data, then it is out of HIPAA, patients will actually have to think about is this app likely to be safe.

It’s the same way you think if you put your money in a bank, is this bank gonna collapse, how am I getting my money out? The same way you write a brokerage firm a check. Can I get this money back, is this a reputable operation. So I think there will be reputational issues on health information as well.