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National Coordinator Rucker Urges CMIOs to Participate in Helping to Improve Interoperability, Usability

March 5, 2018
by Mark Hagland
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National Coordinator Donald Rucker, M.D. urged CMIOs to participate actively in reshaping U.S. healthcare towards the improved interoperability and usability of clinical IS

Donald Rucker, M.D., National Coordinator for Health Information Technology, told the medical informaticists gathered at the AMDIS/HIMSS Physician Executive Symposium on Monday morning that CMIOs and other medical informaticists that they can be instrumental players in helping move healthcare computing to improved usability and interoperability going forward. Dr. Rucker presented the opening keynote address at that preconference symposium, one of numerous preconference symposia being held Monday during the annual HIMSS Conference, currently taking place at the Sands Convention Center in Las Vegas this week. The symposium is being cosponsored by AMDIS (the Association of Medical Directors of Information Systems) and HIMSS (the Chicago-based Healthcare Information and Management Systems Society). The Symposium is being held at the Wynn Hotel and Resort, across the street from the Sands.

Rucker cited increasing consumer empowerment—which he made clear that he supports—and advances in information technology, as elements that will stimulate enhanced interoperability in healthcare going forward, with interoperability being one of the key goals of federal healthcare officials.

“If you look at the computers we have today, they’ve really grown up in an environment where they weren’t really about computing for automation,” but rather primarily for billing. “Our computers today are deeply grounded in documentation and billing. We’ve just had a little bit of elimination of unnecessary workflow. But computers in healthcare look very different from computers in other industries—manufacturing, even service industries,” partly because of the complexity of healthcare delivery processes. Fundamentally, Rucker said, the shift in the health insurance market towards high-deductible health plans will compel consumers forward to search for greater value from the healthcare services they consume, which will in turn force innovation among providers.

Rucker urged the CMIOs and other medical informaticists in his audience to take things into their own hands and participate in pushing their own patient care organizations towards greater usability on behalf of their fellow physicians. “It doesn’t have to be just someone in IT who ‘does it to you,’” he said, referring to internal efforts to improve physicians’ workflow. “You have as much power as anybody in the hospital administration, when it comes down to it. Doctors are noisy, but we don’t use our powers. So take that user-group meeting, figure out how to build a better order system, how you can label things with labels that make common sense to folks. There’s a lot of stuff you can do to advance your work. And with just a little bit more work, you can really dive into these systems.”

Donald Rucker, M.D., at the sympoisum Monday morning


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Moving on to the federal healthcare IT policy level, Rucker said, “Now, as we look at things that make more sense for the government to be more involved in today in the healthcare IT space, two things stand out. We have the electronic medical record, in large part because of the HITECH [Health Information Technology for Economic and Clinical Health] Act. And everybody intuitively thought they would automatically hook up with each other. But that didn’t happen. And that’s just the case everywhere. Windows didn’t have an Internet IP stack in it until the early 90s. So one issue is the raw usability. When clinicians are spending four or five hours a day on the computer—an hour of which has been described in our listening sessions as ‘pajama time’… usability and interoperability are massive issues. And there’s really a national consensus to work on those things.”

Further, he said, “Congress in December 2016 passed the 21st Century Cures Act, with an entire section on usability and interoperability. That was passed with 390-plus votes in the House, and over 90 votes in the Senate, and that’s pretty rare in U.S. politics these days. And it was signed into law by President Obama, after the election. And President Trump has made consumer empowerment a major campaign issue and issue for his organization, and has charged Secretary Azar at HHS[Health and Human Services Secretary Alex Azar] to really be working on consumer empowerment.”

Speaking further about consumer empowerment, Rucker said, “Drilling down into these two issues, that’s a complicated stack. The usability issue has a number of components to it. Often, people will say, they didn’t design the user interface well. You can argue back and forth on that. Some of it is the nature of tools, the nature of incentives. Sometimes, we as docs give bad advice to developers. But there are a number of things on the policy side—I would stay tuned for Administrator Verma’s talk on meaningful use tomorrow. A number of things that make sense in a paper world but don’t make sense in an electronic world. The E & M codes were actually requested by our colleagues in the 1990s in lieu of having time stamp codes. But we have to think about that entire burden. We’re working very closely with CMS [the Centers for Medicare and Medicaid Services] on putting together an entire program on that. John Fleming [M.D.] of ONC is working with Kate Goodrich at CMS to put that together.”

Meanwhile, he said, “So now we get to interoperability. Interoperability is hard; I can get my money out of an ATM in whatever faraway country you might want to go to. But our biological complexity is way, way more complicated than anything in banking. What we do in healthcare is more complex, and therefore harder to do. So the way we look at interoperability is to look at three specific use cases, and gear our interoperability work to do that. Provisions on information-blocking, trusted exchange networks, and open application programming interfaces, are in 21st century Cures.”

Speaking of the Cures Act, Rucker said, “As we look at the use cases to guide us in these provisions, the first is, how do patients get the data themselves? Patients want on their smartphones what they have in the rest of the economy. They want that set of tools on their smartphones. How do we broaden that conversation from just one provider sharing it with another? Patients want control. And that means we’ll have to be on our game, because if patients have it under their control, they’re going to shop. So we’re going to have to up our game; and that’s good for all of us.”

Meanwhile, Rucker said, “The next big case is looking at patients as part of a population. It turns out it’s actually hard to look at patients as part of a population, esp. across multiple health systems. And most of our healthcare is still paid for by third-party payers. And those payers who are ultimately buying on our behalf—they don’t have good visibility into our institutions and what’s going on. A lot of these are one-off [exchanges of data], but there are no standard ways to do this: a broad overview of some swath of data is essential. I don’t believe you can have a learning healthcare system without aggressive computerization. I think a big-data learning healthcare system requires interfaces to get at the data. Why is it that Amazing can look at what we do when we shop and suggest other things to buy, using brilliant machine learning? Why couldn’t we get that data to know that the treatment we’re embarking on, works? That’s modernity, and that’s part of open APIs.”

And, Rucker added, “The third use case is what we’ve always anchored on: how do we get data from one provider to another? And there have always been networks. But we need to expand data in ways where there’s market competition. We’re working on a number of things that will help that, and I think if we solve the patient getting the data and the population getting the data, we’ll nail the providers getting data from each other. Now if we get those three things, what do we do about it? It’s one thing to identify use cases, another to do something about it.”

Speaking of the Cures Act again, Rucker said, “The 21st-Century Cures Act is a pretty amazing law. When I was appointed to this job, I read the entirety of the Cures language, and there’s a lot of pretty smart stuff in there to empower patients and get things going. I want to talk about three things” in that connection, he said. “The first is information-blocking. There are two classes of ways Congress envisioned information-locking being prevented. One is penalties to providers; and then for EMR vendors and networks, that would come through the Inspector General. I think you’ll see in the rulemaking that we’re working on—Congress has defined information-blocking; we’re defining exceptions to information-blocking. But if we work together and work on these interfaces—I think there’s a good chance we can get away without making significant enforcement actions.” He added that the development of trusted networks will be a second important element in progress forward.

“The third thing that’s in Cures that’s maybe the most interesting is open APIs,” Rucker said. “The fascinating thing about that is, when you read that language, it doesn’t just say ‘open API’—it says, ‘open API without special effort.’ An open API just means you’ve exposed your function calls. In order to make things useable without special effort, you need to go to industry standards that people know, you need documentation, publication, some ability to test the code, and Congress put all that in. It’s open APIs without special effort: Congress did call out that this is really a patient empowerment thing.”

Another issue that Rucker mentioned, briefly, was the need to move to the analysis of data across very broad populations in U.S. society, something that remains challenging because of the fragmentation of health insurance coverage. “The population-level data is all still covered under HIPAA,” he said, speaking of the Health Insurance Portability and Accountability Act of 1996. “You still need a legal contract with you the provider and a payer, or a population health vendor you’ve hired, or a consortium you’ve gotten together, like PCORI [the Patient-Centered Outcomes Research Institute]—all that requires a legal HIPAA contract.” But that fact, he said, will continue to protect the privacy of individual patients.

Moving forward towards greater interoperability and usability will take time and effort, Rucker said, but he said he remained convinced that much will change in the coming years, some of it stimulated by the federal government, but a great bulk of it stimulated by consumer empowerment and the mechanisms of the free market. In the end, he said, “I’m pretty optimistic that we’re going to solve these problems. It is a very exciting time. We finally have the computers, the networks, we have enough knowledge about it, we’re in the mood to do it, we have a lot of learning on what works and doesn’t work—so I think we’re in an extraordinary position to use a lot of this technology” to drive forward towards interoperability.

Rucker sidestepped an audience question about the development of a national patient identifier, saying that biometric identification systems and algorithmic statistical investigation could eliminate the need for such an identifier.



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Carequality Seeks Input on FHIR-Based Exchange

October 12, 2018
by Rajiv Leventhal, Managing Editor
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Carequality is seeking input from the healthcare community as it looks to add support for FHIR (Fast Healthcare Interoperability Resource)-based exchange.

According to an announcement from Carequality—national-level, consensus-built, common interoperability framework to enable exchange between and among health data sharing networks—member and non-member stakeholders from across the healthcare continuum are encouraged to participate in the new FHIR Implementation Guide technical and/or policy workgroups. The former will concentrate more on specifications and security, while the latter will focus on the “rules of the road,” officials said.

With much of the healthcare industry either starting to implement FHIR at some level, or planning to do so, the Carequality community is thinking ahead to the type of broad, nationwide deployments that Carequality governance can enable, officials noted.

The new policy and technical workgroups are expected to work in concert with many other organizations contributing to the maturity and development of FHIR, and officials attest that the workgroups will not duplicate the work that is underway on multiple fronts, including defining FHIR resource specs and associated use case workflows. Instead, the workgroups will focus on the operational and policy elements needed to support the use of these resources across an organized ecosystem. 

“Carequality has demonstrated the power of a nationwide governance framework in connecting health IT networks and services for clinical document exchange,” said Dave Cassel, executive director of Carequality.  “We believe that the FHIR exchange community will ultimately encounter some similar challenges to those that Carequality has helped to address with document exchange, and likely some new ones as well.  We’re eager to engage with stakeholders to map out the details of FHIR-based exchange under Carequality’s governance model.”

Cassel added, “We believe that adoption of FHIR in the Carequality Interoperability Framework can advance all of these goals by improving the availability of useable clinical information, expanding the scope of exchange, and significantly lowering the costs of participating in interoperable exchange.”

In August, Carequality and CommonWell, an association providing a vendor-neutral platform and interoperability services for its members, announced they had started a limited roll-out of live bidirectional data sharing with an initial set of CommonWell members and providers and other Carequality Interoperability Framework adopters.

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New ONC Analysis Reveals Progress on FHIR Adoption, Implementation

October 2, 2018
by Rajiv Leventhal, Managing Editor
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The 10 biggest health IT vendors all use at least “FHIR 2” as their API standard

Adoption and implementation of the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) standard in health IT is steadily progressing, according to a blog post from leaders at the Office of the National Coordinator for Health Information Technology (ONC).

The post, penned by Steven Posnack, executive director of the Office of Technology, and Wes Barker, noted that using CMS (the Centers for Medicare & Medicaid Services) and ONC data, the health IT agency analyzed how health IT developers used FHIR to meet 2015 Edition certification requirements. Additionally, they assessed how hospitals and clinicians’ access to 2015 Edition certified-APIs vary across the U.S. Based on this analysis, they found:

  • Approximately 32 percent of certified health IT vendors said that they are using FHIR, specifically the “FHIR Release 2” API (application programming interface) standard.
  • Nearly 51 percent of health IT developers appear to be using a version of FHIR combined with the OAuth 2.0 standard

As the ONC officials pointed out, while the 32 percent figure may seem “low” at face value, the estimated market share of the health IT developers using FHIR is large. They explained that the 10 certified health IT vendors with the largest market share across hospitals and clinicians (eligible for participation in the CMS Promoting Interoperability Programs)—and which encompass about 82 percent of hospitals and 64 percent of clinicians—all use at least the FHIR Release 2 as their API standard. These vendors include some of the biggest industry names such as Epic, Cerner, Allscripts, athenahealth, and others.

As such, overall, of the hospitals and Merit-based Incentive Payment System (MIPS) eligible clinicians that use certified products, ONC found that almost 87 percent of hospitals and 69 percent of MIPS-eligible clinicians are served by health IT developers with products certified to any FHIR version. When estimated for just FHIR Release 2, the hospital percentage remains the same while the clinician percentage drops a bit to 57 percent.


In 2015, ONC issued the 2015 Edition certification criteria that included functional API certification criteria, but no specific standards were required for the API. Just prior to that, The Argonaut Project kicked off as a market-driven FHIR accelerator to develop industry consensus around a set of FHIR Release 2 implementation specifications that could be used to meet the 2015 Edition’s API certification criteria.

Today, many companies have gone into production with FHIR Release 2 profiled according to the Argonaut implementation specifications. Apple (with a FHIR-based “client” app) may be the most notable, but there are indications that many other big tech companies are also planning to use the standard, the ONC blog stated.

What’s more, CMS has reaffirmed in its rules affecting the Promoting Interoperability Programs (formerly known as the EHR Incentive Programs) that the 2015 Edition will be required in 2019. Also, CMS has also invested in FHIR through its own Blue Button 2.0

In a responding statement to the ONC analysis, Blair Childs, senior vice president of public affairs at the Charlotte, N.C.-based Premier, Inc., noted that while it’s promising that many app developers appear to be coalescing around developing consumer apps using FHIR, “we urge the administration to prioritize achieving a similar degree of development across provider-facing applications.  These applications will support providers with predictive analytics, clinical decision support and other workflow technologies.”

Childs’ statement continued, “A strict focus on consuming-facing apps provides a limited view into the state of interoperability. It gives false hope of reaching the tipping point for free and unencumbered data exchange in healthcare. The reality is that we are nowhere near reaching our goal of a data-enabled health system. We need an immediate focus not just on consumer-facing technologies, but on those relied on by the provider community as well. This is why we continue to press for the timely implementation of 21st Century Cures Act interoperability and data standards provisions.”

Childs added, “Until all data is unlocked from EHRs and integrated into clinical workflows, we will continue to face walled gardens of vital information.”

ONC’s Posnack and Barker admitted themselves in the post, “While these data are encouraging, it’s not time to pop any champagne. Industry-wide, much work remains from standards development to implementation.”

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EHR-Compatible Pharmacist Care Plan Standard Opens the Door to Cross-Setting Data Exchange

September 14, 2018
by Zabrina Gonzaga, R.N., Industry Voice
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Pharmacists drive information sharing towards quality improvement

Pharmacists work in multiple environments—community, hospital, long term care, clinics, retail stores, etc.—and consult with other providers to coordinate a patient’s care.  They work with patients and caregivers to identify goals of medication therapy and interventions needed, and to evaluate patient outcomes.  Too often, pharmacy data is trapped in a silo and unavailable to other members of the care team, duplicated manually in disparate systems which increases clinical workloads without adding value.

To address these issues, Lantana Consulting Group and Community Care of North Carolina (CCNC) developed an electronic document standard for pharmacist care plans—the HL7 Pharmacist Care Plan (PhCP). The project was launched by a High Impact Pilot (HIP) grant to Lantana from the Office of the National Coordinator for Health Information Technology (ONC).

Before the PhCP, pharmacists shared information through paper care plans or by duplicative entry into external systems of information related to medication reconciliation and drug therapy problems. This documentation was not aligned with the in-house pharmacy management system (PMS). The integration of the PhCP with the pharmacy software systems allows this data to flow into a shared care plan, allowing pharmacists to use their local PMS to move beyond simple product reimbursement and compile information needed for quality assurance, care coordination, and scalable utilization review.

The PhCP standard addresses high risk patients with co-morbidities and chronic conditions who often take multiple medications that require careful monitoring. Care plans are initiated on patients identified as high risk with complex medication regimes identified in a comprehensive medication review. The PhCP is as a standardized, interoperable document that allows pharmacist to capture shared decisions related to patient priorities, health concerns, goals, interventions, and outcomes. The care plan may also contain information related to individual health and social risks, planned interventions, expected outcomes, and referrals to other providers. Since the PhCP is integrated into the PMS or adopted by a software vendor (e.g. care management, chronic management, or web-based documentation system), pharmacist can pull this information into the PhCP without redundant data entry.


Safety & Unintended Consequences of Interoperability: Establishing High Reliability Principles & Techniques

Interoperability may seem like just a technology challenge, but in actuality it is a people, process, and technology challenge. Healthcare systems increasingly look to create high-reliability...

The PhCP allows pharmacists for the first time to share information with support teams and paves the way for them to support value-based payment. The project goals align with the Center for Medicare & Medicaid Services’ (CMS’) value-based programs, which are part of the Meaningful Measure Framework of improved care team collaboration, better health for individuals and populations, and lower costs.

Scott Brewster, Pharm.D., at Brookside Pharmacy in East Tennessee, described the PhCP as a tool that helps them enhance patient care delivery. “From creating coordinated efforts for smoking cessation and medication utilization in heart failure patients, to follow up on recognized drug therapy problems, the eCare plan gives pharmacists a translatable means to show their value and efforts both in patient-centered dispensing and education that can reduce the total cost of care.” (The eCare plan reference by Scott Brewster is the local term used in their adoption of the PhCP).

The pilot phase of the project increased interest in exchanging PhCPs within CCNC’s pharmacy community and among pharmacy management system (PMS) vendors. The number of vendors seeking training on the standard rose from two to 22 during the pilot. Approximately 34,000 unique care plans have been shared with CCNC since the pilot launch.

This precedent-setting pilot design offered two pharmacy care plan specifications: one specification is based on the Care Plan standard in Clinical Document Architecture (CDA); the other standard is a CDA-on-FHIR (Fast Healthcare Interoperability Resources). The latter specification directly transforms information shared using the FHIR standard into CDA. FHIR is straight forward to implement than CDA, so this is an appealing option for facilities not already using CDA. The dual offerings—CDA and CDA-on-FHIR with lossless transforms—provide choice for implementing vendors while allowing consistent utility to CCNC.

What’s on the horizon for the pharmacy community and vendors? With the support of National Community Pharmacists Association (NCPA), the draft standards will go through the HL7 ballot process for eventual publication for widespread implementation and adoption by vendors. This project will make clinical information available to CCNC and provide a new tool for serving patients with long-term needs in the dual Medicare-Medicaid program and Medicaid-only program.  This is a story about a successful Center for Medicare and Medicaid Innovation (CMMI)funded project that started out as a state-wide pilot and is now rolling out nationwide as Community Pharmacy Enhanced Service Network (CPESN)USA. 

The PhCP is based on a CDA Care Plan standard that is part of ONC’s Certified EHR Technology requirements, so it can be readily implemented into EHRs. This makes the pharmacist’s plan an integral part of a patient’s record wherever they receive care. 

Adoption of the PhCP brings pharmacies into the national health information technology (HIT) framework and electronically integrates pharmacists into the care planning team, a necessary precursor to a new payment model and health care reform. In addition, receiving consistently structured and coded pharmacy care plans can augment data analysis by going beyond product reimbursement to making data available for, utilization review, quality assurance and care coordination.

Troy Trygstad, vice president for Pharmacy Provided Partnerships at CCNC, described the strategic choice now available to pharmacists and PMS vendors. “Fundamentally, pharmacy will need to become a services model to survive. Absent that transformation, it will become a kiosk next door to the candy aisle. The reasons vendors are buying into the PhCP standard for the first time ever is that their clients are demanding it for the first time ever."

The move to value-based payment will continue to drive the need for pharmacists, as part of care teams, to provide enhanced care including personal therapy goals and outcomes. Sharing a medication-related plan of care with other care team members is critical to the successful coordination of care for complex patients.

Zabrina Gonzaga, R.N., is principal nurse informaticist and director of health informatics at Lantana Consulting Group and led the design and development of the PhCP standard. 


Twitter: @lantana_group


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