In a stimulating opening keynote session at HIMSS19, being held at the Orange County Convention Center in Orlando, Hal Wolf, president and CEO of the Chicago-based Healthcare Information & Management Systems Society (HIMSS), gathered together federal healthcare policy officials past and present, for a discussion of the current policy moment in healthcare and healthcare IT. Not surprisingly, the release of two new synchronized, proposed rules by the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC), around interoperability, patient data, and information-blocking, on Monday, overshadowed and gave structure to the entire conversation.
Wolf gathered onstage in the Valencia Ballroom Seema Verma, the current CMS Administrator; Mike Leavitt, the Secretary of Health and Human Services in the George W. Bush administration; Karen DeSalvo, M.D., one of the National Coordinators for Health IT under the Obama administration; and Aneesh Chopra, who served as White House CTO under the Obama administration. In a series of group exchanges, all the discussants reflected on the current moment, and the direction of federal healthcare and healthcare IT policy going forward. Below are excerpts from their discussion.
Hal Wolf: This has been an amazing time, and all four of you have had an incredible impact. Yesterday, some very important rules came out, pretty bold on the proposed rules.
Seema Verma: We say, another day at CMS is another day of disruption, because we’re not trying to protect the status quo; the status quo isn’t protecting patients. We’re looking to [change the industry]. We’re looking to spend one in every five dollars on healthcare in 2026, and that’s imply unsustainable of the country and for every single American. Everything I do at CMS—we’re running Medicare, Medicaid, and the insurance exchanges—giving patients access to their records, that’s one of the most important things we’re doing to improve care and lower costs. We’re empowering patients to be consumers of healthcare and bringing them into the system. We all have places where we’re in the dark: we don’t have pricing information, quality information, or our medical records. So we’re empowering patients. And last year, we put out rules for hospitals. And yesterday was focused on patients. So I think this is extremely important: when they have their data, it gives patients [more power]; for providers, it gives them the ability to make better decisions, for safety reasons, to avoid duplication. And this is also about the data revolution. Imagine what we can do with all that data, in terms of research, in terms of developing new treatments.
Hal Wolf: Governor, you started this process with the wired approach and thinking about it, when you were HHS Secretary.
Mike Leavitt: I have been at this a long time, but it’s worth noting, on this panel, you have people who have served in both Republican and Democratic administrations; but here we all are, focusing on a unified approach; and I think that is a profoundly important moment to acknowledge. It’s also important to acknowledge that transformation is a difficult thing to do; it doesn’t happen overnight. I like to say we’re 25 years into a 40-year transformation. With HIT, we had to invent it…. And years ago, we tried to get all the vendors to share information [from closed, proprietary systems], but that was the wrong approach; we know it now. So let’s create APIs where people can standardize information, and through the power of consumerism, that will change it and that is transformative. It is an iterative approach. We have had to learn as we’ve gone along. And this rule,” he said, will promote significant change.
Wolff: Karen, how did all this look to you when you first became National Coordinator?
Karen DeSalvo, M.D.: When I came to Washington, it was right at that swing of the implementation of HITECH; we were moving into meaningful use Stage 2, which everyone remembers quite fondly [laughs], and moving into a the future. And I came in as a practicing physician—we didn’t have the actionable information we needed, in the clinic, or the hospital, or on call. And all those patients who had to get into their cars again, or get onto buses again, and see us. And it was after Katrina… And we were rebuilding New Orleans. That’s when I got to know Gov. Leavitt, and [later] we began to work together [on a variety of initiatives].
And our opportunity at that time was to kind of put down our pencils about meaningful use. We made a decision that it was a good time to refresh the strategic plan for HIT, which Congress asks the National Coordinator to do. And we took a shift away from it being about the technology, to being about the uses. Cases. It’s about improving and preparing public health, and improving research—not just from the EHR, but from the many places whether the data was being hoarded and held, or blocked. The idea was that it would lead to a more transparent marketplace, and one that was more nimble. I just wanted to call out to the people in the audience—and I feel like such a geek saying this—but if you haven’t read the rule—it’s so worth your time. I borrowed liberally from what people in Secretary Leavitt had done, I borrowed from things that Aneesh had done—he had left the White House by the time I arrived. But applaud you, Seema, for building on what had come before. And I think you’re right, Hal, it’s an incredibly exciting time—we’re really talking about how to create the pull, how consumers are going to drive this marketplace, and how we’re going to work every day on behalf of them.
Wolf: You had made the point before about person-centric interoperability. And we’re talking about giving people the full range of availability of what’s in the clinical record—but the idea of having outside-in access…?
DeSalvo: Sure, the shift in the way we’re thinking about data in the country—we’re recognizing what public health has known for a long time, which is that health is more than healthcare, and we have to have more sources of data than just the EHR; we’re going to have to find sources of data about where we live, work, learn, and play. It includes things like the environment; that may sound fluffy to some people, but make no mistake, the majority of factors, 80 percent, are about things outside the HC system. It’s not just a fluffy, white hat, nice idea, but it drives costs, and determines whether people live or die, and determines the spend in the HC system. So the next journey, in my opinion, is understanding the social determinants of health.
Wolf: Now we get to some interesting parts, right? We’re really looking at now, a setup, to be able to grab a hold at the transactional level, and the rules are getting set up in a terrific way, where Medicare and Medicaid have to make the records available. How do you feel about what’s been proposed?
Aneesh Chopra: This is in the moment we’re in, and why we’re in a bit of a bullish mood about the opportunity. Here’s some sobering context: the meaningful use program, the HITECH Act, had its first effort, in January 2010, with the interim final rule. The notion was that providers had to provide a summary of the patient’s record, in effectively, a machine-readable format. And the concept at the time was that there are lots of bits of information stored that may not be that useful when you leave the hospital, so let’s create a summary of your experience, and make that the basis of our feeds. The presumption was that there would be a catalyst for initial action, and that the government would do the initial work and mandate the floor, and the private industry would do the rest. We’re in early 2019; and the reality is that the content, the information that is available, has not added a single bit of additional clinical information than what we minimally required in January 2019. What about the people who are suffering with cancer—tumor staging data, or the nodes? Each and every one of these pieces of information you’d need, every specialist has their domain area, to understand what’s working and not working. What did we do? We didn’t minimally require that level of content. It doesn’t have the priorities of being freely available, outside a licensing area. And the industry hasn’t self-managed to add more content, led to this rule.
Why do we have to have a rule saying that we need to have the rest of the health record? So the designated record set is the entirety of the health record. We were pushing this idea of a designated record set—and the axe-the-fax thing that Seema is doing now, we were trying to do, too, back then. We had some consensus on how to use email instead of faxing. I asked my brother-in-law, who’s a urologist, about this. And he said, it’s all electronic, I push the eFax button, and it sends the fax to the referring physician. And he didn’t even know his address. And he can’t pick the notes he wanted to send, he was required to send the 75-page CCD, and the PCPs complained. And actually, I’m going to give Karen some credit, but the way we structured the API rule under her leadership was that philosophically, the consumer should have the power. And why don’t we architect that?
We effectively have a Roku set-top box for healthcare data; but the only channel is the common data set—it’s like PBS without “Downtown Abbey.” And we’re going to add more content into that set-top box—notes, labs, images—at least but the core is now there.
Seema: I’d like to show my appreciation for the work that was done before us. Each administration has laid a foundation. Even we’re talking about regulation, my nature is to deregulate; but in this particular instance, the industry wasn’t doing what was important, what was needed, for patients; so we’ve gone in this direction. We need to address the issue of patient ID, patient matching; even on the discharge planning, that’s an important first step; we’ll continue to look for opportunities. The other area that’s important is the post-acute area; and as we’re looking to develop more comprehensive approaches [to extending appropriate data-sharing].
We’re trying to remove the roadblocks, to make it very clear to the system that we’re trying to remove those barriers. I think we’ve made it very clear what we want. But our work isn’t done. We really appreciate the input we’ve received. But we need that input. We like to be short and concise at CMS—when we can… We’re trying. But again, it’s going to take everybody’s input, to make sure we can get to the next level.
Governor, you brought up earlier the non-partisan approach that all four of you have taken. You and Karen have actually collaborated as well. Your program?
Leavitt: Karen raised the notion of social determinants of health, and that this is a bridge into that world. We’re not going to get VB care right until we get to the social determinants of care. So what is a community? It it a discrete group of people for whom you have economic responsibility? Or is it a geographic area? That’s a very basic area that hasn’t been answered yet. Which social determinant is most important? We don’t’ know yet. As Karen suggested, this all works together. I’d like to mention the CARIN Alliance—and CMS has been wonderful in taking much of the effort we’ve put into this, to shape the rule. And we’re not going to be able to do it by having CMS developing a rule. This is a moment for us as an industry step up. We need to see this rule as a call to action for the private sector. For a long time, the government has been behind the commercial sector, in moving this forward. The private sector is now behind the government. We need to take this opportunity to move forward. This is the moment for the private sector to step up and be able to grasp this and move forward with a leap—not just incremental, but a leap.
Wolf: It is an incredible moment. This has been the goal. We have gotten to the point, you brought it up—around this common view. Inevitably, we’re starting with semantic interoperability; we’ve got to find a way to establish what needs to be done—that’s been done—and now we have to figure out what to do.
Chopra: In a way, it is very daunting, but if you break it down to its component parts, we will move forward at the pace of consensus, and it doesn’t take much to achieve broad consensus. And interoperability is now a regulation on the health plans. This is the first time it’s been introduced on the health plan side. So when CMS said, hey, wait a minute, it looks like the industry, the HER community and others, they’re standardizing on the FHIR standard… We can use that… An app says, I want to get medications, and here are the instructions on what you’ll get back. And the advantage with FHIR is that we won’t have a VHS-Betamax fight in healthcare. And so we’re moving forward now as to how we add more content. And CMS said a few months ago… There wasn’t an out-of-the-box FHIR data model for everyone else; CMS had launched Blue Button, but they were the only health plan to offer an open API so the consumer could connect their claims to a third-party app. And Seema, you effectively laid the gauntlet, so people at a a small coalition of plans have volunteered their time in groups of 20—and said, let’s free the database, and work on a common language, and they’ve worked on the basis of consensus. And the CARIN Alliance that Mike and I are part of, this group of technical folks at health plans have agreed on a consensus on technical issues. It’s not hard content to give patients data upon discharge. It’s not hard, we just have to have all the EHRs speak a common language. We have to come together, reach some rough consensus, develop a technical model, and repeat. And these kinds of things don’t have to take years, they can take months, even weeks if we’re lucky. And we’ll get to the palace where the HC model can be communicated in a common language.
Verma: I’m glad you brought up Blue Button 2.0; that was kind of our test case. Before that, BB existed, but it didn’t mean anything to the consumer. We have 18 live apps, and 1500 app developers that are in the sandbox. So we do need the private industry to think about ways to use the data. Unleashing the data is one thing, but we have to be creative about how we use the data. There are so many opportunities around patients, whether to send them live updates or reminders. We heard about a consumer who was able to download information about durable medical equipment for their mom, and they said, wait a minute, it shows that this DME should be available for my mom, and it’s not arriving. So there’s abuse and fraud, too. So we need all sorts of creative apps that can be unleashed to help in all these areas.
DeSalvo: There’s a sense of urgency. It was fine maybe to move along at a slower pace when we were on flip phones, but the world’s changing fast. If we have tools and technologies to serve our people, we ought to have a sense of urgency. Governor Leavitt has said, alone, the private sector will fail, and alone, the public sector will fail, but together, they can succeed. And I agree. We need to use this data to improve health.
