A decidedly mixed picture of the evolving federal healthcare IT policy landscape emerged during a panel discussion on Thursday morning at the Health IT Summit in Boston, being held at the Revere Hotel in downtown Boston, and sponsored by Healthcare Informatics. A wide-ranging discussion looked at what is known, what is not known, what is probable, and what is improbable, going forward, in the policy arena, and how it might affect healthcare IT leaders’ planning for the near future.
The panel, entitled “Policy Update: What the 21st Century Cures Act and Other Key Policy Changes Mean for Your Organization,” was moderated by John Halamka, M.D., CIO of Beth Israel Deaconess Medical Center in Boston. He was joined by Dan Tsai, assistant secretary of health in the Executive Office of Health and Human Services for the Commonwealth of Massachusetts (also Boston), Micky Tripathi, Ph.D., president and CEO of the Massachusetts eHealth Collaborative (also Boston), Jeff Couglin, senior director, federal and state affairs, at the Chicago-based HIMSS (Healthcare Information and Management Systems Society), Dave Levin, M.D., the chief medical officer at the Minneapolis-based Sansoro Health, and the former CMIO at the Cleveland Clinic integrated health system, and David Szabo, co-chair in the Healthcare Practice Group at Locke Lord LLP, a Boston-based law firm.
“Let’s start off with 21st-Century Cures Act,” Dr. Halamka said, opening the panel discussion. What is it we’ll have to do over the next couple of years? 21st-Century Cures has some controversial elements to it—information-blocking is prohibited, and APIs must be open. Should we be scared?”
“It’s mostly a life sciences/biotechnology bill,” HIMSS’ Coughlin noted, “but it gives you an indication that Congress wants us to move forward on interoperability and information-blocking. And in terms of information-blocking, the question from Congress is, we put a lot of money into HIT, with the HITECH Act [the Health Information Technology for Economic and Clinical Health Act of 2009], and how is that money being spent? They want to understand, why can’t EHRs [electronic health records] talk to each other? And why is the data you’re supposed to share not being shared, etc.? And if you just say, “Well, Congressman, it’s complicated,” that’s not going to be very satisfying. So the ban on information-blocking, and increased access for patients to their own information—if they ask you to be able to transfer a patient’s data tomorrow from one provider to another, and you say, “Well, it will take 90 days,” that won’t work, either. So Congress is looking at interoperability now; it’s no longer just a feature, it’s an obligation. It’s not just a good thing to do now; it’s an obligation. It’s the law.
Referencing a brief comment he had made earlier, Halamka said, “Let me qualify what I meant when I said information-blocking doesn’t exist. What I haven’t seen is volitional blocking of information where the technological capability exists.”
“What I have seen is agreements saying, we will share data with you, but limiting it,” Coughlin said. “I think it will be problematic to restrict data-sharing.”
Locke Lord’s Szabo noted that “We’re in the process of waiting for rules to come from the National Coordinator” that will establish a concrete definition of data-blocking to help guide healthcare providers forward. “The actual language is three paragraphs in a 1,000-page bill,” he added. “But it’s defined as a practice that’s likely to interfere with, or prevent access to information. And there are two tests within that about whether information blocking is actually occurring. The first test is focused on vendors, developers, and exchanges, etc. –whether they know or should know that this is occurring. Providers have a second test—whether they know that the exchange of information is being inhibited. We’re waiting for the National Coordinator to provide rules around that, for clarity.”
“The biggest concern I have with 21st-Century Cures and its approach to interoperability,” Tripathi said, “is that it takes a regulatory approach to something that shouldn’t require a regulatory approach. There are CMS and private-insurer contracts that are pushing people into interoperability and data exchange. For example, there are 18 ACOs [accountable care organizations] participating in the Massachusetts Health ACO, and we work with a number of them, and I can attest to the fact that that’s really energizing a lot of them, and it’s happening from the bottom up. My concern is that 21st-Century Cures’ language will actually slow the process of interoperability and possibly be used by vendors to attack each other.”
“I tend to be where Micky is on where this will all play out on the provider side,” Levin said. “Accountable care is really aligning providers and vendors. And I am concerned about some of the large vendors that dominate now, and there’s an open question around that. Listening to the previous talk, which was a deep dive on precision medicine but also a window into all these areas we’re exploring. And it’s clear to me that no one vendor can do all the innovation necessary. And as a provider, I don’t want to essentially be blocked from innovation based on someone else’s agenda. So I would argue for a symphony of applications that can coordinate and collaborate.”
Further, Levin said, “I’m hoping we can unlock what I call innovation constipation right now. We just can’t seem to move fast enough. So I hope that there will be an interoperability layer driven by competition. And top of that, the flowering of a wide variety of innovative applications that leverage that. I just don’t see that in the DNA of any particular company.” “That’s exactly on point,” Halamka said.
“The population that all of our contracts cover represents 30 percent of the lives in the Commonwealth of Massachusetts,” Tsai said. “And with a new waiver negotiation with CMS, we’re in the midst of the most significant restructuring of Medicaid in 20 years; we’re moving to a new ACO model. And many of these entities are integrated payer-provider structures. And we’ve got $1.8 billion of federal funding to move this forward. And both as a payer and from a statewide view, we want to get to integrated care with quality, and in terms of interoperability, we’re hearing that there’s a lot of bottom-up demand to get there, from providers. And we have one of our ACOs coming in that’s a conglomeration of 12-13 community health centers coming together that will have 100,000 lives, but historically, they’ve had very little capital. So the question becomes, how do we incent and move towards data collaboration, without being overly prescriptive? And ensuring that we don’t have a system that allows smaller providers to get stuck. So we’re going to encourage the ACOs forward around this, while trying not to be overly prescriptive.
New Ways to Look at Interoperability?
“There’s provider-provider interoperability, but sometimes there’s provider-patient interoperability as well,” Halamka said. “What about patient-facing APIs?”
“Yes, I’m thinking about the IT part of it, and just as with patient care delivery, we can say, here’s what we want, and there are many ways to get there,” Tripathi said. “And this morning, someone pushed me an article from CNBC with the headline, ‘Apple is quietly working on turning your iPhone into the one-stop shop for all your medical info.’ This might be something like an iTunes for healthcare,” he said. “Apple is already in talks with providers… Maybe they could completely flip this equation on its head, so that rather than thinking about this in a provider-centric way, you could do it electronically the way that India does it in a paper-based way, where patients literally cart around paper records everywhere and have them verified. The interoperability equation is sort of being approached from all different angles—and now, increasingly, patients are being armed with the ability to do that. And Apple may be one of the companies out there who could actually do that.”
Further, Tripathi said, “If you had asked this question five years ago, ‘Whom do you trust most with your health IT data?’ most people wouldn’t have mentioned Apple. But I saw [a recent online survey of healthcare IT professionals who were asked] whom they would trust most with the protection of their data—and it wasn’t providers, or EHR vendors—it was Apple.”
“I’m honestly of two minds about this,” Levin said. “On the one hand, patients and providers live in the 21st century; they just go to work in an earlier century. There’s no hiding or running away from that. But patients are not homogeneous, and their needs are not homogeneous; so another important aspect of this is really looking at how diverse patients are in terms of their interaction with technology. So it will be important to come up with solutions that match patients’ needs. And Lori Posk, M.D., who leads these activities for Cleveland Clinic—she does amazing work, but has to deliver it through some substandard interfaces. So interoperability will allow people like her to deliver experiences more like those that patients experience outside healthcare.”
“And there will be challenges to face in reaching out to all sorts of difficult-to-reach populations,” Coughlin said, “including around behavioral health and substance abuse.”
Speaking of the MACRA (Medicare Access and CHIP Reauthorization Act of 2015) law and the MIPS (Merit-based Incentive Payment Program) program within MACRA, Halamka turned to his panel and asked, “What are you all hearing about the timeframe and scope around it?”
“I think the key question is when we’ll actually see the rules,” Szabo said. “We were supposed to be getting them last Friday, so we could be getting them this Friday, is the latest we’ve heard. The thing we’re hearing from Secretary Price, from HHS [Health and Human Services Secretary Tom Price, M.D.]—I think that what HHS [the Department of Health and Human Services] is trying to do is to really talk about how the reporting burden can be reduced, how the regulatory burden on clinicians can be reduced. I think that there is a tension there between what they’re trying to do in terms of interoperability—HHS in general doesn’t necessarily want to take a heavy regulatory hand in terms of what needs to be reported—but at the same time, there need to be some rules of the road provided to help physicians understand what their obligations are—so how they define that, and thread that needle, has yet to be determined.”
What about Meaningful Use?
“Let me be very controversial,” Halamka said to his panel. “I took a very unscientific poll of all the CIOs in Boston and asked them ‘If you were given a requirement for meaningful use Stage 3 in 2018, would you put it on your priority list?’ And 100 percent said they would not. Whether or not we’ll get a rule that forces us to do something in 2018, there’s not a lot of confidence about that.”
“I like the spirit of what it’s supposed to do, but there are mind-numbing and awful details,” Tripathi said. “I hope the rule clarifies some of those questions, but I’m not sure it will.”
Speaking of outcomes reporting requirements, Coughlin said, “If you’re recruiting a doctor in 2020, you’ll want to make sure that they reported in 2018. Remember, this is a zero-sum game: for every winner under MIPS, there’s supposed to be a loser. And 21st-Century Cures requires the Secretary to produce a plan on reducing data burdens on doctors. So we can look forward to the Secretary’s plan for reducing the burden. This is just a mess.”
“So what’s the sleeper issue here?” Levin asked his fellow panelists. “What struck me is that mental health parity may be the sleeper issue. As a family doctor, I’m delighted to see that we’ll put more emphasis on mental health and addition and behavioral health, and there’s got to be more emphasis on that. But the sleeper issue is that it’s highly distributed, confidentiality is a problem, and we don’t have a lot of technology yet in the area. So what we’re planning for and not planning for—that’s the thing that I urge people to think about. There are workforce issues involved, too,” around behavioral healthcare management. “We’ll have to figure out a lot.”
“Will Stage 3 of meaningful use involve no penalty phase, and people will be able to ignore it?” Halamka asked.” “Folks are holding back on their advocacy around meaningful use Stage 3,” Szabo replied. “The focus right now is largely now on the AHCA”—the Affordable Health Care Act, the Republicans’ plan to repeal the Affordable Care Act. “I think that the hospital associations and other large provider associations that would really be impacted by any meaningful use changes, are really waiting for their opportunity to make their points on that. But with the focus right now on the Hill on repeal-and-replace, they wouldn’t get much traction around this—but it will become important, when the time is right.”
“And we have to look at this through the lens of Tom Price, [CMS Administrator] Seema Verma, and Don Rucker”—Donald Rucker, M.D., the new National Coordinator for Health IT, Halamka said. “EHRs? He loves them because patients can get access to their data; he hates them, because of the administrative burden involved. So in 2018,” he asked, “will we see the hospitals having to do anything? Or will there be some latitude? And Don Rucker was a Beth Israel Deaconess CMIO who had also worked at Siemens, but doesn’t have policy experience. I think we’ll see incredible domain knowledge. But we’ll have to see. Any comments” on the HHS officials? He asked.
“We have no idea of what ONC [the Office of the National Coordinator for Health IT] is going to do,” Tripathi said. “There’s 200 staff there. And in the President’s budget, their budget is cut by a third. But it’s unclear whether that will have an effect, because we’re not sure what they’re going to be doing. It feels like they were headed into a trajectory of becoming more of a support organization to CMS. But if CMS starts to get watered down, the whole thing will start to unravel. The one really legitimate role that the federal government could play in a very fragmented industry, would be around safety. And I’ve heard the CEOs of large vendors say that one of their big concerns is that, as their systems get deeply embedded in every health system they’re in, that there’s not a safety event that could happen in any patient care organization that wouldn’t in some way involve HIT. And they would love to have some kind of vendor-neutral safety reporting mechanism, in the same way that NTSA [the National Transport and Safety Authority] does for transportation issues.”
