What are some of the key healthcare IT policy and public health priorities that senior federal government officials are pursuing right now? On Tuesday, Aug. 10 during HIMSS21, sponsored by the Chicago-based Healthcare Information & Management Systems Society, and being held this week at the Sands Convention Center in Las Vegas, National Coordinator for Health IT Micky Tripathi, Ph.D., M.P.P., and Daniel Jernigan, M.D., M.P.H., Deputy Director for Public Health Science and Surveillance (DDPHS) at the Centers for Disease Control and Prevention (CDC), answered questions posed by HIMSS president and CEO Hal Wolf and HIMSS’s senior vice president of government relations Tom Leary, during a session entitled “Answering the Call: The Importance of Interoperability Across the Spectrum in the Age of COVID-19 and Beyond.” HIMSS’s Wolf and Leary appeared in person, while Tripathi and Jernigan appeared remotely during the session.
After making some opening remarks, HIMSS’s Wolf asked National Coordinator Tripathi to share some broad comments about the top policy goals of the Office of the National Coordinator for Health IT (ONC), and how Tripathi sees the landscape around interoperability and public health right now.
Tripathi, who noted that his academic background was in political science and economics, said that the predominant question for him right now is, “How do we improve the effectiveness and quality of the healthcare system? What’s the right balance—in terms of the government role, what’s the correct role of regulations, versus market power? Having lived all of my time in healthcare and outside of government until January 20 of this year, I do have a keen appreciation of the ways in which government can screw up; but I also have a keen appreciation of the ability of government to improve things as well,” Tripathi remarked.
“As an industry,” Tripathi said, “we stand at one of those very pivotal moments in time where policy, culture, and circumstances” have all led us to a place of challenge and opportunity. “We’ve spent more than $40 billion in public investments and much more in private investments, laying the foundation for hospitals and doctors to work with information systems,” he said. “But I think we would all agree that we didn’t do all that work simply to achieve more efficient billing” on the part of providers. “And the COVID-19 pandemic, as tragic as it has been, has also done us a service in terms of pressure-testing the system,” with regard to how the system of electronic health records (EHRs), coupled with other information systems and networks, has been able to respond to the public health emergency of the past year-and-a-half in the United States.
Fundamentally, Tripathi said, “now that we’ve got a foundation of EHRs in place,” it is imperative that EHRs and all forms of clinical information systems support the development of data and information superstructures that can “help us identify inequities in healthcare and address those.” In that regard, he said, “ONC has some levers; we have the CURES Act,” he said, referring to the 21st Century Cures Act, passed by Congress and signed into law by President Barack Obama in December 2016, and which, among numerous other provisions, addresses “the electronic access, exchange and use of health information technology, including through technology that provides accurate patient information for the correct patient, including exchanging such information, and avoids the duplication of patient records.”
“We can also improve market transformation through better communication with the market,” Tripathi said. “And we can also [work as] a coordinator within the federal government. And sometimes, it’s about aligning federal regulations, but also about aligning federal government market actions, which are at least as powerful. What can you expect from the Biden/Harris Administration? What is practical and feasible, and leading wherever it can,” Tripathi said. “And doing that in as transparent a way as possible—and to do that with as much direct engagement as possible. And we’re a federal government agency, and a part of another federal government agency, in HHS”—the Department of Health and Human Services. “We can’t control everything in IT.”
That said, Tripathi emphasized, “I am committed to not allowing the perfect to be the enemy of the good; or to allowing the government to be an obstacle.” In that regard, he said, he is focusing on five top areas of priority: continuing to respond to the COVID-19 pandemic; renewing an emphasis on “fulfilling the letter and the spirit of the CURES Act”; EHR adoption and optimization; health equity; and “federal healthcare policy alignment” among all the relevant agencies within the federal government.
After referencing the lessons learned so far during the pandemic—including the revelation of the many silos in the public health system around data and reporting—Tripathi went on to strongly emphasize his commitment to “a renewed emphasis on fulling the letter and spirit of Cures. Cures was a landmark piece of legislation” when it was “signed into law in 2016,” he underscored. “It includes prohibitions on information-blocking and requirements for standardized APIs”—application programming interfaces. Further, he noted that, “When the Biden-Harris administration took over, none of the law’s provisions had taken effect. April 5.” What’s in store in the near future, in that regard? Two things, he said. First, “an expansion of data requirements, and of standards for APIs.” And, significantly, “in the first quarter of 2022,” the unveiling of the provisions of TEFCA, the Trusted Exchange Framework and Common Agreement (TEFCA). (Senior Contributing Editor David Rath’s July 13 report on TEFCA provides extensive background on the current status of ONC’s plans in that area.)
Commenting on the term “information-blocking,” which was significantly referenced by former National Coordinator for Health IT Donald Rucker, M.D., and former Administrator of the Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma, Tripathi told the assembled audience that “I’d like for us all of us to agree that we should stop using the term ‘information-blocking,’ and instead call it ‘an obligation for information-sharing.’ We don’t believe that every entity is implicitly guilty of information-blocking,” he said. “The industry has obviously made a tremendous amount of progress in a short time; but it’s incomplete and inconsistent. The Cures Act brings more information-sharing.” It was noteworthy that his tone in discussing information-blocking/information-sharing stood in strongly marked contrast to that of Verma, who had regularly hectored provider leaders on the subject, during her tenure at CMS.
Further, Tripathi went on to note that “We’ve gotten feedback that there remains confusion about TEFCA. We take this communication very, very seriously. We’re redoubling our efforts to get more feedback, by adding more communication channels. You’ll be seeing those very soon.” And, he emphasized that it will be important for provider leaders to recognize that “This process of ongoing policy refinement is not a bug, it’s a feature of federal policy development; and there’s no single rule that can apply to all situations.”
Tripathi also said he wanted to make sure that the audience understood that “We’re often asked very specific questions about seeking adjudication in specific circumstances. We don’t even have advisory opinion authority,” in that regard. “We’re not responsible for investigation and enforcement.” Indeed, he said, should anyone at ONC try to provide very specific advice on an individual level, doing so would only add to any confusion that already existed in a specific area. What’s more, he said, “Let’s remember that the Cures Act involves a paradigm shift. But it doesn’t supersede other regulations; it complements them. We’ve tried to align the rule with existing HIPAA [Health Insurance Portability and Accountability Act of 1996] regulations. We’ve been asked a lot of times to redefine core HIPAA concepts. We’re not going to do that, that would cause more confusion and pain. We work very closely with our colleagues at OCR”—the Office for Civil Rights inside the Department of Health and Human Services—to harmonize processes wherever possible.
Working with the CDC
Tripathi went on to enumerate seven key areas in which senior ONC and CDC officials are working together right now:
Ø Lab data interoperability
Ø A common data model: the United States Core Data for Interoperability, or USCDI, “based on what EHR systems are already capable of today”
Ø Public health system standardization—focusing on standardizing the many local public health systems’ data systems
Ø A nationwide interoperability network: “How can public health become a first-tier consumer of that network, and how do we use TEFCA in the context of public health?”
Ø A nationwide FHIR [Fast Healthcare Interoperability Resources] roadmap: “What’s the CDC/public health role in that?
Ø Public health reporting incentives
Ø “How do we think about a public health information architecture, from an enterprise perspective, and think fresh about an enterprise approach that’s very common in the private sector?”
With regard to that ONC/CDC collaboration, Dr. Jernigan told the audience that “There are four major priorities for data modernization at CDC; we’re focused on breaking down the information silos. We’re managing change and governance. We’re changing the way we’re doing business at CDC; we know that culture change is hard. We’ve established a new governance structure to review, approve and monitor all of our IT investments.”
Specifically, Jernigan said, “The first priority is automating and expanding the collection of data from core public health systems. Electronic case reporting from EHRs and increased automated reporting” are very much being looked at, he said. Unfortunately, “Health departments can’t ingest a lot of that data. Second, electronic laboratory test reporting” needs to be standardized. In fact, he said, “We want to establish a cloud-based platform” for the sharing and storage of key public health data. “We’ve implemented that at CDC.”
And, Tripathi noted, an executive order from President Joe Biden has ordered the workgroup that he and Jernigan co-chair, to create a report for HHS Secretary Xavier Becerra. “We’re working on that report now.” Among other things, he noted, “We’re working on a gap analysis” in terms of improvements that could be made to improve public health data collection, reporting, and sharing, with the report due to Secretary Becerra by the end of this year or early next year.
Asked by an audience member about what health IT vendors do to support public health reporting, and what hospitals and doctors should demand from health IT vendors, Tripathi answered that “I think it’s two sides of the same coin, demand and supply. First and foremost, be a demanding customers. There are standards and specifications already out there, per USCDI and FHIR. The EHR vendors are very responsive to what their customers want and need. The regulatory cycles move very slowly. For example, look at FHIRR4: December 1, 2022—we have a requirement” to issue regulations “for that standard by December 1, 2022. I know that that seems like a very long way away,” he said. “But vendors can move forward with public health facing apps and APIs. So I think it’s all about pushing vendors towards a development approach.”
