At the HLTH Conference held this week at the Aria Resort in Las Vegas, the session entitled “U.S. Government Investing in Health Innovations” stimulated candid, oftentimes-spirited discussion of the role of the federal government in promoting technological and service innovation in the U.S. healthcare system.
The session held on Tuesday, May 8, and led by Rasu Shrestha, M.D., the chief innovation officer at the 30-plus-hospital, Pittsburgh-based UPMC health system, and executive vice president of UPMC Enterprises, its technology test-bed division, included two other panelists: Bruce D. Greenstein, Chief Technology Officer in the U.S. Department of Health and Human Services, and Aneesh Chopra, former CTO of the United States, and now president of CareJourney, an Arlington, Va.-based consulting firm and solutions provider founded in 2014 to help patient care organizations transition to value-based payment models.
Dr. Shrestha and Messrs. Greenstein and Chopra discussed a wide range of topics, around how, to what extent, in which contexts the federal government can or might act as a facilitator and catalyst for technology and other progress in U.S. healthcare; as well as payment- and data security-related considerations around innovation. As Shrestha said at the outset of the session, “We all know about the Washington in the headlines,” the Washington of political conflict and division. But beyond that Washington, he said, “There’s a quiet Washington that continues to do a lot of work.”
Rasu Shresta, M.D., Bruce Greenstein, and Aneesh Chopra on May 8 at HLTH
In that context, Shrestha asked Bruce Greenstein to describe the KidneyX Project, which is described on HHS's website thus: “Each year approximately 4000 organs recovered from deceased donors (nearly 3000 kidneys) were not used for transplant and instead were discarded. This project proposes to analyze the underlying causes of the high rate of kidney discards and identify tools to provide transplant physicians and patients with better information on kidney quality and expected outcomes to inform decision-making and reduce the risk of discard. Based on input from multiple end-users and stakeholders these may include improved information-sharing, data analysis tools, and proposed changes to organ transplant systems and policies. The goal” of the initiative,” the HHS website says, “is to increase the number of successful kidney transplants and reduce kidney transplant waiting times.”
Speaking of the initiative, Greenstein explained to Shrestha that “It’s not regular government innovation, or the kind where you have a little festival for a day and say you’re so innovative. My mom died in 2008 of kidney disease, at 59 years old, after 15 years with kidney disease. I remember taking her to the dialysis center, where the machines, the care, everything, was set up in the exact same way as 15 years before. In fact, for 60 years, there’s been no innovation in the end-stage renal disease care in 60 years. And there’s massive market failure. We spend more on kidney dialysis than the entire Department of Commerce, NASA, and you can throw in the FTC and FEC as well—so our idea was to change the market. We went out and asked investors and innovators why there hasn’t been change. They said, well, you guys seem to like it as it is. So we’re using the federal government’s X Prize funds to encourage invention and innovation, so we can pay differently for this. This is one example of an area where the government can address market concerns and innovations.”
“Is this perhaps a clever way also for the government to cleverly start working with the private sector?” Shrestha asked. “You’re very clever!” Greenstein replied. “Yes, this is a perfect way to start. And we also want to try to start to fix one piece after another, to use the power of investors, VC [venture capitalists], and material scientists and engineers, people from outside the industry, to address our issues.”
Turning to Aneesh Chopa, Shrestha said, “During your time as CTO, you saw a radical shift around data. Pace of innovation hasn’t caught up. What’s your perspective on this?” he asked, cited the potential for public-private collaboration around data analytics, information technology, and other forms of technology development.
“Bruce and I will do our best to demystify the avoiders,” Chopra said. “So here’s what I’m going to context: the government historically has been a participant in the innovation economy mostly by investments in infrastructure, setting rules of the road broadly, or setting a target like going to the moon. In 2008 when President Obama was running for president, he said he wanted us to close the innovation gap between the pace of change in the private sector and that of the government. So we had a theory of how we would make this shift, and that theory involves a new form of government investment that I want to make sure to communicate here.”
Per that, Chopra said, “The first thing we decided to do was to change the default setting from closed to open on the data held by the government. Now on the healthcare side, the most difficult set for the private sector to use had been the Medicare file. Why? It was seen as a privacy violation for physicians, because someone could determine through the claims database how much physicians were paid, and one could extrapolate how much physicians were paid overall. But now, that Medicare database is open for business. There are public use files where that data set can be used as a fuel for innovation. So that default changed. The second thing the government did is that we got much more active in the standards debate. There had historically been a notion that the private sector should develop standards, and that the government should stand back—you don’t want the government weigh in on Betamax versus VHS. But in the absence of government involvement, we had this decade of gobbledygook in medical records, where it was difficult to express things like your problem list, medication list, allergies list, etc.”
“But wouldn’t the government’s role around standards had been better had the government enforced national standards around EHRs [electronic health records]?” Shrestha asked.
“Phenomenally good question,” Chopra said. “Now, in 2009, there were a few legends in HIT—Rasu, and John Glasser [the former CIO of Partners Healthcare in Boston, and later, CEO of Siemens], for example. And John said, we’ve got electronic records, but if you ask me to produce a list of patients who smoke, I can’t do it, I can’t do that query; there’s no standard format for that question. Now, if a core data set had already been standardized at the time we launched the HITECH Act, we would have gone for it. Meanwhile, another investment area for the government is, we’d fund the R&D for standards development. Now, per this Apple Health thing, if you sourced the original technologies that Apple relies on that are standards-based, they have their origins in an R&D project we helped fund around how a consumer can access their right to data, along with FHIR. So the government invested in opening up the data, engaging in standards, and then allow the government to create prizes that Bruce just mentioned.” In other words, that foundation that the federal government laid around standards, has helped to fuel the Apple innovation around patients’ direct access to their patient records on their iPhones.
“Here’s an audience question,” Shrestha said. “Will we see a greater role by NIST in terms of enabling innovation?” he asked, referring to the standards developed by the National Institute of Standards and Technology (NIST).
“Great question!” Chopra said. “NIST is a division of the Commerce Department that is the opposite of top-down: it’s bottom-up, it’s industry collaboration, a convening authority. So what’s powerful about NIST is when we have a market failure and can’t reach consensus, NIST can corral troops. NIST was explicitly empowered in the energy sector to do so. We put $10 billion into smart meters at the same time we put $40 billion into EHRs. NIST was actually an active player there, and worked on an explicit roadmap to make sure that the data and smart meter were available to consumers. That had been the policy going back to 2012. It wasn’t until 2015 that we finalized the rule to allow consumers to connect their electronic health data to apps. That’s the spirit of NIST, of government convening. And the fact that Apple deliberately chose an open stack was due to the NIST model, which was a convening model. Goldilocks—not too top-down, not too chaotic, but convening.”
A downside risk policy question enters the discussion
“Bruce, we talked about payment reform, a lot of things that happened in the prior administration around ACOs. So, pun intended, looks like the ACO program is at risk now, per this press release from NAACOS,” he said, referencing both comments that Seema Verma, Administrator of the Centers for Medicare and Medicaid Services (CMS) had made this week, and the results of a survey by the National Association of Accountable Care Organizations (NAACOS) that found that 71 percent of its member leaders who responded to the survey said that they would likely leave the Medicare Shared Savings Program for ACOs if they were forced to assume downside risk.
In his May 9 report on all of this, Healthcare Informatics Managing Editor Rajiv Leventhal noted that, “Earlier this week, CMS (the Centers for Medicare & Medicaid Services) Administrator Seema Verma remarked that ‘upside-only’ ACOs (accountable care organizations) that do not take on downside risk have not generated enough results to date. Now, Healthcare Informatics has learned that a CMS rule is forthcoming that could shorten the duration ACOs can stay in one-sided risk models. Verma’s remarks, made at the American Hospital Association (AHA) annual membership meeting in Washington, D.C. on May 7, aligned with what HHS (the Department of Health & Human Services) Secretary Alex Azar said at AHIP's (America’s Health Insurance Plans) National Health Policy Conference in March where he stated, ‘[Federal ACO] programs were intended to give providers three years to learn how to accept risk and share savings, but the results have been lackluster,’” Leventhal’s report noted.
Further, Leventhal wrote, “Verma went into more detail this week, noting that downside-risk ACOs have achieved significant savings to Medicare, ‘while upside-only ACOs are increasing Medicare spending, and the presence of these upside-only tracks may be encouraging consolidation in the market place, reducing competition and choice for our beneficiaries. While we understand that systems need time to adjust, our system cannot afford to continue with models that are not producing results,’ she said.”
Responding to Shrestha’s question, Greenstein said, “The government is making the market more fertile, to enhance value. Medicare Advantage plans, second area. Every year, we’re increasing the number of people in MA plans. Large plans, some national, some local, are investing in that area. Large plans buying vertically integrated provider organizations, making investments in the social determinants of health. We’ll continue to see innovation on the payment side and on the delivery side, we don’t’ tell them what to do. And we’re continuing to use our authority at CMMI [the Center for Medicare and Medicaid Innovation] to do innovative delivery models. It’s really about value. In this case, value does not have to equal risk. What do we think about as value? Quality, affordability, and consumer-centricity.”
That means, Greenstein continued, that the federal government is trying to improve choice and quality in healthcare. “So with this, we have the ACO model,” he said. “You just referenced a press release where 71 percent of the ACOs said if there’s downside risk, they’re likely to leave this program. Well, maybe this program is not for you. Because if you only want a little bit of extra money but don’t want to take risk, maybe this isn’t the program for you. There’s no ‘A’ for effort here; you have to produce results.”
“It’s time to deliver?” Shrestha asked. “Yes, it’s time to deliver,” Greenstein responded.
What about data security?
Shrestha went on to broach the topic of data and information security at a time when leaders are trying to push forward into innovation in U.S. healthcare. “Given the recent Cambridge Analytica scandal, does the government need to change its approach to privacy?” he asked his panel.
“Yes,” Chopra replied. “Here’s the challenge: as we speak, we’ve now put in place the technical ability for the consumer to connect to their health records. That is a data liberation model. But,” he went on to say, “when you move the data from a HIPAA-covered entity to a consumer app, there is no protection. It’s the equivalent of Facebook. The worst we can do is if you lie to a customer, we can bring you up on charges of deception. In my opinion, that is insufficient; and this has been the case in the Internet economy from the very beginning. My team led the charge to create a Consumer Privacy Bill of Rights under the Obama administration. And one of the core principles included that one was, I should have the right to control the sharing of my data. Second, I should be able to consent on collection, meaning, I would like permission to access X Y and Z data from you on the front end. And lastly, I want to be able to manage its use. And by constraining the context under which the consumer is permissioning the use of the data, you allow for some rational thinking. If I wanted to play a game using my psychometric profile, I wouldn’t have anticipated that that data would be sold.”
In any case, Chopra said, “We submitted this Bill of Rights to Congress, but it didn’t go anywhere. My hope would be that Congress would take a second look at this. And we have a hook for this. While Google or Facebook may not feel they need to worry about this, I believe that for apps touching sensitive HC information, we could create something equivalent to a digital Hippocratic oath—industry-led—that would protect consumers’ data. If we could do that, create an industry-led digital Hippocratic oath, that would be very big.”
“Can we revisit HIPAA? Can we talk about it?” Shrestha asked, citing an audience member-supplied question.
“Whoever asked the question, they’re onto something,” Greenstein said. “This is an active question under discussion at HHS. HIPAA is mostly about insurance, not information. And a lot of information is not covered by HIPAA. But it’s often used as a cultural shield to avoid doing something. So we started asking the question of lawyers around the department. And it turns out, it’s not that hard; you start writing regs. So does HIPAA need to be modernized to keep up with today’s level and desire for sharing, for modern technology capabilities, and for the marts we might use, around formats or standards? That’s the question. Or do we need a much better marketing program, because HIPAA is so grossly misunderstood? We’re interested in doing either, but something needs to happen. And maybe every single person in this room has had some negative brush with it. And if the government created this problem, we can fix it.”
Per that, Chopra said, “We made the requirement that patients need to be able to get their data within 3 days of discharge, and 90 percent of hospitals said they could do this, and everybody was high-fiving, but what was the denominator in the rule? 53 percent of the hospitals in the US publicly reported last year that not a single patient had requested an electronic copy of their discharge summary, by their own admission. There’s no way those patients were told that they were allowed to take an electronic copy. So let’s understand the right of my access. If I invoke my right and you refuse, the government can fine you. We created a penalty under the Obama administration. Let’s start understanding that authority, and I can say as an outsider now, that’s our opportunity. The consumer has the right, we’ve got to start building the DNA in the healthcare system, to honor that right.”
Innovation: which way forward?
“Let’s talk about the specifics around innovation at HHS. There’s almost a bit of a perception that at the federal level, there’s not as much of a sense of urgency in pushing this forward, and that seems wrong in what you’ve said,” Shrestha said. “I just came back from Sacramento where they had their innovation conference, I gave a keynote there, and there’s a remarkable sense of energy and activity at the state level. What are you doing” at HHS? He asked.
“We believe we need to franchise our model, to not exhaust our resources,” Greenstein said. “They’ve created an excellent model in California. We are trying to be the front door to HHS, the big glass front door for innovators, start-ups, entrepreneurs. To some extent, we compete for the same innovators to focus on our projects, as others do. We want them to work on our problems right away. So we try to defeat these four myths: that the sales cycle is too long, the priorities are ambiguous, the process is byzantine, and they don’t know who to call, in the government. And if you’ve ever tried to sell into a Blue Cross or Blue Shield plan, our sales cycles are a lot shorter. So we’re working with the FDA [Food and Drug Administration], the NIH [National Institutes of Health], and other agencies, to move forward.”