Pondering the DeSalvo Era at ONC—And the Healthcare IT Policy Challenges That Lie Ahead: An Analysis

Oct. 4, 2016
As Karen DeSalvo, M.D. leaves the ONC, a kaleidoscopic array of policy and process issues faces her successor and the agency itself, at a time of tremendous change and challenge for healthcare IT and healthcare IT policy

The announcement on Thursday, August 11 that Karen DeSalvo, M.D. was stepping down from her position as National Coordinator for Health IT, while not particularly surprising, was nonetheless both noteworthy and worth pondering. What does it say about where things are right now with federal healthcare IT policy? The meaningful use program? The healthcare IT zeitgeist in the United States? The announcement certainly comes at a moment of significance for healthcare IT policy.

Indeed, Dr. DeSalvo is leaving her position at a time of unparalleled uncertainty both at the Office of the National Coordinator for Health IT (ONC), and for U.S. healthcare IT and healthcare IT policy in general. Further down in this blog, I’ll have more to say about this—but it is an important element that puts yesterday’s announcement into a particular context.

Meanwhile, it is important to note that the post of National Coordinator for Health IT is of relatively recent vintage—the first National Coordinator, David Brailer, M.D., was appointed in May 2004 at the same time that President George W. Bush created the Office of the National Coordinator for Health IT. And, including Dr. Brailer (2004-2006), there have now been six National Coordinators up to Thursday: Brailer; Robert Kolodner, M.D. (2007-2009); David Blumenthal, M.D. (2009-2011); Farzad Mostashari, M.D. (2011-2013); Jacob Reider, M.D. (who was briefly Interim National Coordinator, October-December 2013); and DeSalvo (2014-2016). Vindell Washington, M.D. was named the new National Coordinator on Thursday, at the same time that Dr. DeSalvo’s departure was announced (she will now take on full-time her post as Acting Assistant Secretary for Health, a position she took on part-time in October 2014, in order to lead HHS’s Ebola response team during 2014’s Ebola crisis).

In that context, Dr. DeSalvo’s tenure as National Coordinator has actually been among the longest in terms of duration, lasting nearly three years, though with an asterisk, as she had already spent nearly two years splitting her time between the National Coordinator role and the Acting Assistant Secretary for Health role. Indeed, with the exception of Dr. Reider, who was Interim National Coordinator for less than three months during the gap between Dr. Mostashari and Dr. DeSalvo—all of the other National Coordinators have had tenures of two to two-and-a-half years. In that sense, Dr. DeSalvo’s full departure is “right on time,” as this position has proven from the start to be a rather short-lived one compared to many federal offices. And though some level of changeover might be expected in such federal agency leadership positions, one could legitimately question (and please count me in as someone who is questioning it) why such is the case here, given the centrality of the office to federal healthcare IT policy and the exceptionally rapid and constant pace of change in our industry. I’ll say it here: federal healthcare IT policy is in fact in certain ways rather exceptional; certainly, it is a key element in the federal government’s overall attempts, across political parties and presidential administrations, to help bend the cost curve on the United States’ $3.3 trillion, soon-to-be-$5.6-plus-trillion, annual healthcare expenditures. In that sense, healthcare and healthcare IT leaders nationwide, could not be fault for asking for exceptional management, including continuity of management, from ONC.

Still, the harsh Realpolitik of these positions is that, regardless of which candidate prevails in the November presidential elections, a new administration will come into place in January, and most of the officials in position’s like Dr. DeSalvo’s will be rotating off then. That being said, there is another very significant element here. Dr. DeSalvo’s departure also comes at a particularly delicate time for the ONC, as the agency struggles to guide the meaningful use process, already bifurcated by the passage of the MACRA legislation, which is replacing meaningful use for physicians with the MIPS program; and as hospital leaders strenuously advocate for a replacement of Stage 3 of meaningful use, with officials at ONC and CMS (the Center for Medicare & Medicaid Services, ONC’s sister agency within the Department of Health and Human Services). What’s more, the status of the drive towards interoperability, one of the issues that has resonated as something of a consensus cause among providers, remains unclear.

What is clear is that Dr. Washington will be stepping into the National Coordinator role at a time of unprecedented overall uncertainty at ONC, as providers push hard for ONC and CMS officials to step away from its role as the stern taskmaster of rigorous meaningful use requirements, and more towards something like that of a federal partner to providers in pursuit of innovation along a number of dimensions.

Regardless of whether Dr. Washington will be able to help reshape ONC in that way (one very good sign is that he has served as a multi-hospital system CMIO and CEO, so he at least has practitioner and patient care organization executive experience), healthcare and healthcare IT leaders are clamoring for change at the agency. Many—perhaps even most—leaders of patient care organizations have been dissatisfied with their interactions with ONC and CMS officials, particularly around the contentious issues embedded in the transition into Stage 3 of meaningful use. And it happened to be Dr. DeSalvo’s bad luck of the draw that she came into her role just as things were becoming dicey—and rather contentious—in the evolution of the meaningful use program. In certain ways, DeSalvo’s cautiousness and diplomacy ended up working to her disadvantage, as her reluctance to create news headlines also led to an absence of engagement at key moments, on key topics, with key healthcare and healthcare IT leaders.

In that regard, she was unlucky where Farzad Mostashari had been eminently lucky. Dr. Mostashari, with his sunny disposition, his passion and sense of mission, and his exceptional political abilities, was the natural antidote to the patrician, cool demeanor of David Blumenthal, an academic’s academic. Dr. Blumenthal had helped to lay the foundation for meaningful use, but it took a real politician, Dr. Mostashari, to sell the program to providers. And neither Dr. Blumenthal nor Dr. DeSalvo were salespeople; and who can say how important salesmanship was, has been, and will be, in the overall scope of the National Coordinator role?

Meanwhile, if salesmanship seems something that Dr. Washington may well need in order to succeed at the job in the coming months, so are some other capabilities. For one thing, the massive turnover at ONC has been concerning to many, for two years now. At one point, during the summer and autumn of 2014, there was so much high-level turnover at ONC that I wrote a blog on the subject. I was also at that point in time hearing from agency insiders and others with inside knowledge, about serious morale issues within the agency, which made things seem even more worrisome. Dr. Washington, as he comes into his National Coordinator role, will need to help right the ONC ship internally as well as externally, to prepare the crew at the agency for the choppy waters ahead.

And what’s ahead can easily be seen in a glass-half-empty-glass-half-full prism, as the U.S. provider community, besieged by policy, reimbursement, and regulatory mandates, seeks both guidance and reassurance from federal healthcare authorities. There is an opportunity at ONC—and of course, more broadly at CMS as well—to firmly push providers—and vendors—in the right direction, towards cooperation, clinical transformation and continuous clinical performance improvement, interoperability, and population health and accountable care (in the broadest senses of those terms), while also reassuring providers of the good intentions and partnership of both agencies.

But a great deal needs to be worked out, not the least is the resolution of the Stage 3 meaningful use for hospitals conundrum. And even beyond that set of challenges, what does ONC want to be in the next few to several years? And how do senior ONC and CMS officials see their agencies’ relationships evolving with providers, and with vendors, and in the case of CMS, with payers as well?

Dr. DeSalvo, in her tenure at ONC, accomplished a fair amount—though it could be said fairly that she is departing the agency still leaving a great deal of work unfinished. Among the notable accomplishments under her tenure was the October 2015 release of a final Interoperability Roadmap. The question is, over the long term, will that Roadmap retain its conceptual and practical value, if it is not continuously shepherded forward by the National Coordinator? Meanwhile, Dr. DeSalvo also engendered some grumbling for what some healthcare IT leaders perceived as insufficient sensitivity to the growing complexity of the requirements under Stage 2 of meaningful use, and the potential requirements under MU Stage 3. In that regard, what happens this autumn is going to be quite significant for ONC, as the agency attempts to chart a course that will lead to policy and implementational success.

Going beyond Dr. DeSalvo’s tenure specifically, ONC as an agency faces an almost dizzying array of policy and process issues. Among the many, many concerns facing ONC officials in the near term are questions around how health information exchange (HIE) policies will evolve forward at the federal level. In that regard, to cite just one example, two articles published in the July issue of Health Affairs and co-authored by Julia Adler-Milstein illustrate some of the thorny issues at hand. In the second Health Affairs article, “Engagement In Hospital Health Information Exchange Is Associated With Vendor Marketplace Dominance,” co-authors Jordan Everson and Adler-Milstein write that, “Across all levels of vendor market dominance, hospitals using EHR systems supplied by the [market-]dominant vendor engaged in an average of 45 percent more HIE activities than hospitals not using the dominant vendor. However, when the dominant vendor controlled a small proportion—20 percent—of the market, hospitals using the dominant vendor engaged in 59 percent more HIE activities than hospitals using a different vendor. But when the authors performed detailed analysis looking at four EHR vendors—Epic, Cerner, Meditech, and McKesson—and the impact that their relative dominance in different markets had, on HIE development, they found that in markets strongly dominated by Epic, that dominance by that particular vendor suppressed HIE development outside Epic’s orbit, whereas the opposite was true when it came to markets dominated by Cerner, Meditech or McKesson. If the implications of the authors’ study of EHR vendor participation in markets and the influence of vendor dominance bear out, then that is one of many situations that senior ONC officials need to look at as serious policy concerns.

Similarly, as senior ONC and CMS officials look beyond the conclusion of the meaningful use program, they will need to consider in substantial detail how they interact with the EHR and clinical IS vendor community. For those of us who speak regularly to a wide range of provider leaders, one inescapable conclusion is that the provider community is relying very strongly on CMS and ONC officials to put quite intense pressure on vendors to move forward in very practical ways towards true semantic interoperability and to vastly improve the usability and even the core technological platforms of their EHR and other solutions. No provider organization, even among the largest integrated health systems in the country, has the market power to force the reluctant EHR and clinical IS vendors to do what they’ve been promising to do for many years now but continue to fail collectively at doing—to provide truly interoperable, truly reliable, truly user-friendly, truly technologically advanced, products. An even thornier issue will be the extent (if any) to which ONC and CMS consider looking at antitrust concerns, as a few mega-gigantic EHR vendors move to decimate all the others and eliminate choice in the EHR vendor market. Again, as in numerous other policy areas, only federal officials can force change in this area.

And these are just a few of literally dozens of important issues that will require strong, consistent leadership from ONC in the coming years. The physician community, overwhelmed by the prospect of the MACRA/MIPS implementation in the coming months, is particularly vulnerable to stress and potential crisis, as is this country’s cadre of small, rural, and independent hospitals, whose leaders are struggling to keep up with currently released mandates and requirements, let alone new ones.

Among other huge bushel baskets full of issues: how to promote standards, such as FHIR, that will accelerate the development of APIs that can transform clinical and operational computing; and how to better harmonize outcomes reporting requirements to optimally support accountable care, population health, and value-based care delivery and purchasing.

Above all, as Dr. Washington comes into his new role, he will be faced with an almost impossible range of policy and practical challenges, including one of the most conceptually simple yet pragmatically thorny challenges of all: how to prioritize what ONC can accomplish in the near term.

In the broader sense, the next few years in healthcare and healthcare IT offer tremendous challenges and opportunities, as our entire healthcare system rushes towards a cost cliff (with the Medicare actuaries just last month publishing their latest projections for total U.S. healthcare spending, and predicting that our system will go from its current $3.3013 trillion annual spending on healthcare, to $5.631 trillion by 2025, a breathtaking 70-percent increase in nine years). Healthcare IT leaders are going to need to be key participants in a U.S. healthcare system-wide effort to bend that cost curve and at the same time improve outcomes, through a focus on population health management, care management, and a relentless drive towards efficiency and cost-effectiveness. But healthcare IT leaders are also looking to Washington for leadership and guidance, and the new National Coordinator will be a key figure in providing direction in all this.

Given this kaleidoscope of issues, concerns, challenges, and opportunities inherent in the current landscape of U.S. federal healthcare IT policy in the U.S., my mind inevitably goes to a great quote from the Roman orator and philosopher, Seneca the Younger: “The fates guide those willing to change; those unwilling, they drag.” In the new National Coordinator for Health IT, our industry needs someone who can help guide the industry as an uber-partner, someone who can right the internal ship at the agency, and someone who has the vision, and the practical wherewithal to make that vision a reality, to help bring the industry into the future. The new healthcare is here—with all its opportunities and challenges. I wish Dr. DeSalvo well in her HHS role, and I especially wish Dr. Washington well, as we’ll all need for him to be a National Coordinator who can bring out the best in all of us, and in the industry as a whole.

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