Rubber meets the road
As David Blumenthal, MD, sees it, Stage 2 is where the rubber meets the road for the Meaningful Use EHR Incentive Program – the government's grand scheme to turn the American healthcare system on its head.
The program's promise and appeal from the start was that it would move healthcare from an industry stuck in antiquated ways and mired in paper, into a smooth, sleek, efficient digital system, more akin to what consumers experience when banking, or buying a book or refrigerator on Amazon.
Blumenthal, who served as the third national coordinator for health information technology – is often credited as the architect of the meaningful use program.
"I certainly didn't act alone," he told Healthcare IT News in a recent interview. While Blumenthal presided over the Office of the National Coordinator at the time the concept of meaningful use was fleshed out, the first regulation was written, and the phased pattern established, he noted, "The actual provisions were very much a group effort – a huge amount of input from our Health IT Policy Advisory Committee at the Office of the National Coordinator."
Today, having steered smoothly through Stage 1, and the government having spent more than $30 billion on the program, the industry has arrived at Stage 2 – and healthcare providers appear to be lost, unable to find their way. Some have complained that Stage 2 is just too hard, too complex. Others have cited competing projects, such as conversion to ICD-10. Moreover, many EHR vendors had not yet certified their products for Stage 2, making it impossible for providers to meet the Stage 2 attestation deadlines.
CMS and ONC announced last December the government would extend Stage 2 through 2016 and begin Stage 3 in 2017 for providers that have completed at least two years in Stage 2. Even so, by the end of May, only four hospitals and about 50 physicians had attested to having reached Stage 2.
More time to arrive at Stage 2 is likely to help. But, what effect might the delays have on the program – on the vision for healthcare transformation?
"Well, I take a long view," Blumenthal said. "My belief is that the United States healthcare system was flawed in ways that prevented, or dis-incented the adoption of electronic health records, and that to accelerate that process required government intervention."
The intervention was not perfect, he acknowledges, but it accomplished the basic goal of accelerating the adoption and use of electronic health records. It means that most Americans' health information is in digital form.
"The consequences of that digitization of information in a reasonably systematic way, guided by meaningful use, will have enormous, difficult to predict, and generally positive effect on the American health system over a generation to come," Blumenthal said, "That's my view of it. I know that physicians find certain aspects of meaningful use problematic. Some find it too aggressive. Some find it not aggressive enough. But, I still think it was a reasonable way to proceed, and we'll see the results over decades."
John Halamka, MD, CIO of Beth Israel Deaconess Medical Center in Boston, sees the Stage 2 extension as a positive move, not as a retreat by the federal government from its commitment to the meaningful use program. At the time CMS and ONC announced the extension, he saw the need to explain it.
"This is NOT a delay of Meaningful Use in 2014 (Stage 1 or Stage 2)," he wrote on his Dec. 6, 2013, blog "All 2014 certification and attestation deadlines are still in force," he added. "This announcement adds another year to Stage 2, delaying Stage 3 to 2017 and making Meaningful Use Stage 2 a three-year cycle."
Call for HITECH reboot
John W. Loonsk, MD, CMIO at CGI and adjunct associate professor at Bloomberg School of Public Health at Johns Hopkins Center for Population Health IT, served as director of interoperability and standards at the ONC from January 2006 to December 2009. Part of his time at ONC coincided with Blumenthal's tenure as national coordinator.
In an analysis piece Healthcare IT News published May 29, Loonsk called for a "hard reboot" for HITECH, and offered a 10-point plan for how to proceed.
"Here's to giving Karen DeSalvo, the new national coordinator for Health IT, all the support she needs to do a full and hard HITECH reboot," Loonsk wrote. "While it is reasonable that many HIT outcomes are still unfulfilled, the path forward seems murky. EHR adoption has surged, but much of what has been broken about health IT in the United States still remains."
No. 9 on Loonsk's 10-point plan is a call for "meaningful relief."
"Providers need to be left alone for a while," Loonsk wrote. "They were already under incredible strain from many non-HIT related pressures. HITECH added to these pressures (necessarily) by fostering EHR adoption. But meaningful use added much more strain through, sometimes, aspirational criteria that demand workflow and process changes well beyond simply adopting an EHR. Give providers meaningful relief from many of these new business requirements. It is not clear that there are incentives to sustain them after HITECH and the infrastructure needs attention before many are viable."
No. 8 on Loonsk's list is a call to "double down on interoperability."
"There needs to be a broader, more inclusive, standards process," Loonsk wrote. "The ONC Standards & Interoperability Framework has good ideas, but there are many more needs than ONC alone can promote. There are also needs for broader standardization and specification of technologies beyond just data and messages. Constructively re-engage the industry to help make this happen."
Interoperability on the mind
"I think a lot about interoperability and whether we could have promoted an exchange more rapidly and more effectively, and I'm not sure we could have – the reason being that the standards were not adequate at the time to support it, and there was no demand – real demand – for it," Blumenthal said, when asked, in hindsight, could ONC have done anything differently.
"When we began this process, there was very little capability, and/or demand for interoperability. It was a theoretical idea."
If ONC had placed a big emphasis on interoperability, there would have been pushback, Blumenthal surmised. The question, he said, would have been, "Why are you so interested in interoperability when there isn't any information in digital form? There's nothing to exchange."
"So, we adopted the view that basically you had to operate before you could interoperate, and that we would have to create an infrastructure on top of the electronic health records that we were putting in place to create interoperability."
Succeeding national coordinators, however, began to put interoperability center stage.
"Most vendors really do see it now as part of their self-interest to be as interoperable as possible," then National Coordinator Farzad Mostashari told me in an interview in March 2013, "but we still hear a lot of complaints from providers that their vendors are putting up what they believe are artificial roadblocks to them being able to share information, to participate in health information exchange.
As Mostashari, sees it, interoperability is a shared responsibility.
"Fundamentally, we have to reduce the cost and complexity of interfaces through standards and implementation guides," he said. "The vendors have to really be able to do Stage 2. It's a huge step up – huge step up on interoperability. Vendors are really going to have to step up to the plate in terms of being able to achieve the Stage 2 expectations for true vendor-to-vendor coded, clinical structured, documents being able to have kind of ubiquitous protocols with security in place. That's a big step for the industry and meaningful use Stage 2 sets the tempo and expectations for that."
Fast forward a year, and National Coordinator Karen DeSalvo, MD, who has taken the baton from Mostashari, is gathering input from stakeholders on several topics, with interoperability at the top of the list.
"I'm in a listening phase about all of this," she said in a February 2014 interview. What I'm hearing is that there are some technical aspects to it that are real and important. There have to be some standards to allow for that interoperability to occur. There are some business issues that relate to not just the business model, but to the marketplace itself and providers, which are themselves right now undergoing a lot of evolution and change because of quality and payment reform. It's a dynamic place. I think from a business case standpoint, there's been work to do to get some of that appreciation."
A few days later DeSalvo announced at the Fourth Annual Health Care Innovation Day in Washington, DC, hosted by ONC and the West Health Institute, that interoperability would be her top priority for 2014.
In hindsight, Blumenthal believes ONC did what was possible at the time, and that meant focusing on EHR uptake. The time was not right during his tenure to press for interoperability.
"My view of the process of promoting electronic health record adoption and the creation of a national information infrastructure is that it's a complex interaction between technology and market forces," Blumenthal said. "And, the technology doesn't advance very fast unless there's demand for it, and the demand doesn't advance as fast as you'd like unless there's a technology to support it. So, there will be a constant interplay between the technology and the demand for technology.
"What I do believe focusing on adoption did was it proved that the government could accomplish a first step, and that was to incent adoption. I don't think people realize how important it was for the government to establish its credibility at being able to move this process along on some dimension."
Blumenthal supports the findings of the JASON report "A Robust Health Data Infrastructure," an April 2014 document prepared for the Agency for Healthcare Research and Quality, part of the Department of Health and Human Services.
"I think that the Jason Architecture that has been proposed now through a report to the Office of the National Coordinator and others seems to be a reasonable way forward," Blumenthal said, "and I'm confident that, with the pressure now that is growing for interoperability and the demand on the part of people in the market – users of the technology – we will now take that challenge on in a very important and aggressive way. And, that seems to be the way the Office of the National Coordinator and CMS are moving.
The report lists the many benefits of health data exchange:
Satisfy the growing demand of patients for flexible access to their own health information
Offer faster, interoperable access to patient records by health care providers
Reduce errors within individual records and across records
Reduce redundant testing and diagnostic procedures
Produce more complete health records and more accurate health data
Promote better longitudinal tracking of patients and patient groups
Promote improved standards of care and reduce the incidence of errors in clinical practice
Provide research data of unprecedented power to inform clinical care, public health, and biomedical research
Facilitate better communication among health care providers and patients
Enable electronic detection of health care fraud
Improve tracking of health care costs and benefits, thereby enhancing understanding of the economics of health care delivery.
"Whether any of these benefits can be realized depends not only on the framework for health information technology and exchange, but also on the details of any such implementation. It is therefore vitally important to get those details right," the report noted in the executive summary.
"The JASON report builds upon our understanding of the technical, broad policy and privacy and security issues that are both opportunities and challenges as we advance an agenda of meaningful exchange and interoperability," DeSalvo wrote in her April 16, 2014 blog. We look forward to engaging with our Health IT Policy and Standards Committees, but also across the health care industry, with consumers, providers, employers, purchasers and health IT developers as we evolve our roadmap for interoperability, a robust health IT infrastructure, and a shared set of priorities for our nation."
Is Stage 2 too hard?
Given the widespread complaints about Stage 2 challenges, could it be that Stage 2 simply just too difficult to accomplish?
"Well, the big difference between the first and second stage is the interoperability and information exchange requirement," Blumenthal replied. "I think it shows how slow adoption would have been if meaningful use had been defined as accomplishing exchange in the first order. So, I think that, in a sense, what we're seeing is the rubber hit the road – demand for meaningful use becoming demand for real meaningful use rather than just for data entry. And, that will challenge the healthcare system."
He added some words of caution in gauging the difficulty of Stage 2.
"You have to factor into the complaints the possibility that there are underlying economic motives for organizations not to exchange information, he said. "It's always easy to blame the technology when, in fact, what is going on is you don't want to lose what you view as proprietary information."
Blumenthal expects pushback – "because we haven't invested sufficiently in standards development; we don't have the political will to force compliance and consensus around a set of standards; and we don't have
"So that's the political and economic environment in which we are tending to blame the technology and the federal regulations when in fact I think the concern really lies elsewhere," he said. "I don't think there is any reason why we couldn't have interoperability if we were invested in it sufficiently and if we supported it sufficiently and if we empowered government and the private sector to come to rapid agreement on standards.
Blumenthal believes that one of the ways to make transformation of the healthcare system a national priority to by making providers accountable for the quality and cost of care they provide, thereby creating a business case for good information and thereby also making them desperate to know what's actually going on with their patients – so they don't duplicate the use of services and they don't get penalized for underperforming on quality.
"And, then, they will come to the table and push very hard on Congress and the executive branch and on vendors to participate in the standards development activity that is meaningful," he said.
Blumenthal is seeing the beginning of this, but the efforts are far from perfect.
"Part of what we see is an initial reflex on the part of larger healthcare organizations is to get really good interoperability within their walls and then to fight it outside the walls," he said. What we haven't got yet is really meaningful financial accountability for the total cost of care for a patient population, which providers are responsible for.
"The accountable care organization movement is a step in that direction, but it's still nascent, and it's still really more about shared savings than it is about risk. And, risk is a lot more motivating than the opportunity for savings."
As he sees it people who work on the IT side of healthcare, don't appreciate how much their work is dependent on the financial incentives and culture that prevails in the general healthcare business.
"I think people who assess the performance of electronic health records, also tend to assess them as a stand-alone technology rather than seeing the technology for what it is, which is a tool that business leaders use to accomplish business objectives," he added. "If the business objective is to maximize billing, electronic health records can be used to do that. If it's to secure and digitize and retain information, they can be designed to do that. If it's to exchange information and have a complete picture of the patient as the patient experiences care in the community, it can be used to do that."
Looking to the future
Some in the industry doubt that meaningful use will – in the end – produce the promised results. Blumenthal is not among the doubters, though he does allow that the results could take longer than anticipated to achieve.
"We need to keep perspective on this," he said. "The question is not whether the world will be perfect, but whether it will be better. And, the world will be better, even with electronic health records that are imperfectly interoperable and where exchange is limited to certain parts of the country or certain sectors of the healthcare economy. They'll be better because within systems – like Mayo or Kaiser – there'll be true interoperability, and there will be an enormous improvement in the power of information to modify care. Care will get better, patient outcomes will improve, care will get more efficient. But it won't be as good as we'd like it to be, or as good as it could be.
He suggested it would be necessary to carefully assess the relative roles of the government and the private sector, ensuring that we get the best out of this market.
"Markets do fail," he noted. "They're not perfect. Look at Wall Street. Look at the GM imbroglio right now. We leave private sector entities to do their own things, and they don't always do the things we want, and government steps in, regulates, penalizes, protects consumers – the same dynamic I think will unfold in this market, but it will take a while. It'll take private and public action to get us where we need to get."
Turning around a behemoth of a healthcare system is challenging. Is it possible that some of the efforts, especially regarding meaningful use, have been in vain?
"Oh, no," Blumenthal answered. "I think this is an enormously powerful development. Just look at this discussion of the Apple-Epic alliance. That was unimaginable before HITECH. But now there's such a critical mass – we're reaching a critical mass of digitized information, so that it's possible to think about packaging electronic health record data and funneling it to consumers in ways that could empower them in totally unforeseen ways.
"Just think of the suite of applications that might be developed to take the data that's available in the Kaiser electronic health record and make it available through a whole series of sophisticated Apple-developed applications to people with chronic illnesses. I mean it's a whole new field of medicine. That's got to have huge benefits over the long term. So, getting that information into digital form, which was the key purpose of meaningful use Stage 1 lays the groundwork for, I think, progress that was unimaginable before.
"Just the very fact that Microsoft, Google, IBM – all these powerhouses of technology – now have big healthcare investments and businesses and the number of startups. This was all unimaginable before five years ago.
"So, this is huge progress. It's just that there's a lot to-ing and fro-ing; there's a lot of friction; there are a lot of things that are less perfect than we'd like them to be.
But, in the sweep of history? We're finally entering the modern information age in healthcare.