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Top Ten Tech Trends 2018: Could A New Interoperability Wrinkle Solve Healthcare’s Biggest Challenge?

August 29, 2018
by Rajiv Leventhal, Managing Editor
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There has been much debate on the possibility of mandating providers to participate in health information exchange activities to stay in Medicare

Editor’s Note: Throughout the next week, in our annual Top Ten Tech Trends package, we will share with you, our readers, stories on how we gauge the U.S. healthcare system’s forward evolution into the future.

 

For a few years now—from the latter part of the Obama administration through the first 18 months of Trump’s presidency—federal health officials have been adamant about moving from an era of EHR (electronic health record) adoption to one in which these technology systems will make it easier for providers and patients to share health data across the care continuum.

Of course, healthcare interoperability has been a great pain point to date with one of the primary barriers being the lack of a true business incentive to compel providers and EHR developers to be “open” with this ever-so-important data. To this end, in recent proposed regulations, federal health leaders have clamped down, perhaps harder than ever before, in their ongoing effort to guide stakeholders to a world in which seamless health data exchange is the norm, rather than a rarity.

There may have been no greater evidence of this than the Centers for Medicare & Medicaid Services’ (CMS) proposed updates to Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) in April. In the rule, CMS proposed to re-name the federal EHR Incentive Program, or meaningful use, choosing to now call the program “Promoting Interoperability.” But just how far the federal agency will go beyond “promotion” is what’s particularly fascinating.

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CMS wrote that it will be seeking public comment, via an RFI (request for information) on whether participation in the government’s Trusted Exchange Framework and Common Agreement (TEFCA) initiative—a federally-constructed plan released in January to jolt interoperability among providers—could be used as a vehicle to mandate providers to share data.

Indeed, more specifically, in the proposed regulation, CMS said it will be soliciting feedback on if the agency should revise its “Conditions of Participation” for hospitals that would require them to perform health information exchange activities such as: electronically transferring medically necessary information upon a patient discharge, sending discharge information to a community provider via electronic means; and making information available to patients or third-party apps. And if providers did not meet these Conditions of Participation, if they were to be revised, the consequence would be that they would not be able to participate in Medicare.

How Are Stakeholders Reacting?

As one might imagine, seeking comment on whether or not interoperability should be a requirement for Medicare participation has elicited a wide array of responses across the sector. Comments on the RFI were due to CMS by the end of June, and there was no update from the agency when it published the final Promoting Interoperability rule in early August on what the next steps might be. But as one health IT expert, Jeff Smith, vice president of public policy at the Bethesda, Md.-based AMIA (the American Medical Informatics Association), points out, it could be some time before there are actual interoperability mandates.

“You have to keep in mind the realities of the process. What you need to remember is that the Conditions of Participation aspect of the [proposed rule] was specifically called out as an RFI. And the RFI tries to get information that the agency could consider for potential future rulemakings,” explains Smith.

In other words, CMS did not include the potential Conditions of Participation revision as part of the proposal; rather, the RFI is the step leading up to a potential proposal. And “potential” is the key word to keep in mind, Smith says.

Jeff Smith

Nevertheless, health IT trade groups were keen to give their feedback on the RFI in their public comments. While some stakeholders were adamantly against the possibility of revising Conditions of Participations to revive interoperability, others were strongly in favor.

Kelly Hoover Thompson, CEO of SHIEC (the Strategic Health Information Exchange Collaborative), a national collaborative that represents health information exchanges (HIEs) and their partners, believes that imposing regulatory requirements is not the best solution to the interoperability problem. “I don’t think it has to go as far as what CMS [could be proposing], but I do think that it’s an indication to the industry, on a good level, that so many people are [thinking about] how to make things better,” says Hoover Thompson. Other major industry trade groups, such as AMIA, the American Hospital Association (AHA) and the College of Healthcare Information Management Executives (CHIME), similarly attested in their comments that CMS is taking the wrong approach.

Kelly Hoover Thompson

That said, others feel differently. A letter signed by more than 50 organizations, representing plans, providers, patient groups, ACOs (accountable care organizations) and health IT companies, has called on CMS to take more aggressive action to promote interoperability and advance health information exchange. Some of these signed groups include prominent industry names such as Beth Israel Deaconess Care Organization, Blue Shield of California, the New York eHealth Collaborative (NYeC), and Aledade.

Valerie Grey, director of one of the signing organizations of the letter—the New York eHealth Collaborative—says that NYeC supports potentially changing the Conditions of Participation with an incremental step.  Grey says that more vendors and providers have been willing to make data available for shared patients, but further progress is necessary.

More broadly, though, Grey points out that not every hospital can afford the EHRs that are enabling some of that interoperability today. However, being that NYeC’s role is to promote and enable information exchange, it is natural for the organization to support efforts that seek to promote information sharing, she says.

Will Business Incentives Change?

In the end, just as the previous administration changed incentives to encourage EHR adoption, the current one will have to find ways to inspire the next stage of interoperability: the efficient movement of health data. But it’s a delicate balance and it becomes a question of where to apply the pressure and how to incentivize the kind of behavior that is desired, AMIA’s Smith says.

Another piece of the puzzle is an information blocking rule from the Office of the National Coordinator for Health IT (ONC), which was originally expected in April, but now has been delayed until September [and has not been published at the time of this story]. It’s this rule, coupled with TEFCA, that experts believe could move the needle on incentivizing providers and EHR developers to interoperate.

“The hope was that the information blocking rule would be the definitive answer to the business incentive piece to the interoperability puzzle,” says Smith, noting that there are plenty of questions that need to be answered even within that rule itself. For instance, he contends, “data availability—when it comes to matters of life and death are issues of public health. But data availability for non-matters of life or death, or matters of an individual, comes down to more business questions—such as do I need to share the data for everyone who asks for it?”

Regarding TEFCA, officials are likely to put out a second draft version and another public comment period will follow, says John Kansky, the CEO of the Indiana Health Information Exchange, and appointed member of the Health Information Technology Advisory Committee (HITAC), which has had a lot of influence in making TEFCA recommendations to ONC. “It’s fun to think about and I feel privileged in having a front row seat in helping advise ONC, but we don’t know how the regulation will evolve,” Kansky admits.

That said, it’s not helpful or informative that opinions on TEFCA are all over the board, he adds. There are two buckets of folks that are thinking about and opining on this regulation, Kansky says: those who are strongly in the camp of advocating for consumer access and being in control of their data; and those who have been working on creating industry interoperability, be it through EHR vendors or HIEs, and trying to make it a reality. “Those two groups tend to have different views on regulation,” he points out.

John Kansky

Going forward, Smith asserts that the key will be how these policies that the industry has been expecting for some time now will intertwine with one another. “What I am hoping beyond hope is that the reason these policies are not yet publicly available is because the powers that be are still trying to make sure that there is harmonization and a logical inter-reliance across them,” he says.

Meanwhile, Kansky believes that the interoperability space is “ripe for bold change and opportunity. ”A few years into the future, he predicts, between the EHR interoperability approaches that will be prevalent, in addition to HIEs and regulations like TEFCA, the ecosystem will find a way for everything to work together. “Even when one sees the other as competition or making the way of life more challenging, this is what we do in the free market in the U.S.,” he says. “We throw a bunch of different approaches at a problem and sometimes we make a mess, but in the end we figure out a solution. And the solution isn’t one thing, pure and simple; oftentimes it’s a complicated ecosystem—but it works.”


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Hospitals Outline Agenda to Accelerate Interoperability

January 22, 2019
by Heather Landi. Associate Editor
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Hospitals and health systems are making progress in sharing health information, with 93 percent making records available to patients online, but collaboration across many private and public sector entities, including technology vendors and policymakers, is necessary to achieve comprehensive interoperability, according to a new report from national hospital associations.

The report reviews the current state of interoperability, which show promises but is still a patchwork system, as well as outlines current challenges and provides an agenda for steps to take to improve interoperability among health IT systems. The report was compiled by seven national hospital associations—America’s Essential Hospitals, American Hospital Association (AHA), Association of American Medical Colleges, Catholic Health Association of the United States, Children’s Hospital Association, Federation of American Hospitals and the National Association for Behavioral Healthcare.

“We see interoperability in action all around us. Mobile phones can call each other regardless of make, model, or operating system. The hospital field has made good headway, but it’s time to complete the job. We are united in calling for a truly interoperable system that allows all providers and patients to benefit from shared health records and data, leading to fully informed care decisions,” AHA President and CEO Rick Pollack said in a statement.

“For the best care today, it’s the data stupid. Quality care depends on having the right information at the right time, so our patient’s records need to be available in the hospital or wherever our patients receive care. Hospitals are joining together to support improving interoperability because it is the key to assuring the best for our patients,” Federation of American Hospitals President and CEO Chip Kahn said in a prepared statement.

The report highlights that hospitals and health systems are making progress in sharing health information, with 93 percent making records available to patients online, up from 27 percent in 2012. What’s more, 88 percent of hospitals are sharing records with ambulatory care providers outside their system, up from 37 percent in 2012. And, 87 percent of hospitals enable patients to download information from their health record, up from 16 percent in 2012.

“We are inching closer to, but still short of, the ideal of seamless interoperability. In health care, this refers to the capacity to send and receive a patient’s health information from multiple sources between different systems and locations with its integrity intact,” the report authors wrote. “The information communicated must be useful to the receiving care provider, patients and families, and result in the care decisions that are best for them. Today, interoperability is a partially-achieved aim, working well in some but not all settings.”

The report authors note that the key to leveraging health data’s full potential for improving patient care is the establishment of a framework for compatible technical and linguistic (semantic) standards adopted by all parties that “lead us to a generic, vendor-neutral data exchange platform.” “We currently lack universally agreed upon ways of sharing and using information — “rules-of-the-road” that make possible the uncorrupted transfer of patient data between differing (and often proprietary) health record systems,” the report authors wrote.

Looking at progress made to date, hospitals and health systems have invest hundreds of billions over the past decade in electronic health records (EHRs) and other IT systems that record, store and transfer patient data securely among medical professionals. In 2017 alone, hospitals and health systems invested $62 billion in these IT systems.

According to the Office of the National Coordinator for Health Information Technology (ONC), the vast majority of hospitals use multiple mechanisms to share health information, and more than half must use four or more. Furthermore, most hospitals devote significant resources to manually matching patient records, since we do not have a national patient identifier, the report states.

And, according to 2010 AHA survey data, only 16 percent of hospitals had a basic EHR system in place. By 2017, 97 percent of surveyed hospitals had adopted a certified EHR system.

What’s more, hospitals and health systems have made efforts to link via health information exchanges (HIEs), however, the report notes while HIEs do deliver on some of the promises of interoperability, the exchangeable data is often limited to a regional or statewide scale. “In addition, some HIEs cannot reliably carry out full data exchange within a health system among different source technologies, or data

 

 

exchange across health systems including ambulatory or post-acute settings,” the report authors wrote. Also, HIEs may not enable individual patients to access their data.

The report authors also outline the ongoing barriers to comprehensive interoperability. According to an AHA analysis on barriers to health data exchange and interoperability, 63 percent of respondents cited the lack of capable technology as the biggest barrier. That survey also identified difficulties matching or identifying the correct patient between systems also as additional costs to send or receive data with care settings and organizations outside their system as significant interoperability barriers as well.

“Barriers to interoperability must be addressed in order to support the level of electronic sharing of health information needed to provide the best care, engage people in their health, succeed in new models of care, and improve public health. Doing so requires collaboration across many private and public sector entities, including hospitals and health systems, technology companies, payers, consumers, and federal and state governments,” the report authors wrote.

The report also outlines “pathways” to advance interoperability with a particular focus around privacy, security, standards and infrastructure as well as industry stakeholders committing to share best practices and lessons learned.

Among the report’s recommendations, new standards are needed to overcome the significant gaps making communication difficult between systems. “For example, APIs (application programming interfaces), including those based on the FHIR (Fast Healthcare Interoperability Resources) standard, allow for more nimble approaches to accessing needed data. Health care will benefit most from use of standard, secure, non-proprietary APIs that minimize the added costs associated with proprietary solutions and gatekeeping. API access should support both patient access to information from providers and other stakeholders, and the use of trusted third-party tools to support clinical care,” the report authors wrote.

“While we have made much progress, at present, we have the incomplete outline of a national data-sharing system in place, one that lacks the agreed upon rules of the road, conformance, technical standards and standardized implementations to ensure that all HIE platforms can communicate correctly with each other,” the report authors concluded.

The report authors note that true interoperability that advances improved health care and outcomes is within reach with effective federal policies and key stakeholders doing their part. The report calls on health systems to use their procurement power to drive vendors toward compatibility in systems design and lend a voice to the development process.

EHR and IT vendors, in turn, should commit to more field testing and consistent use of standards, the report authors wrote, and avoid pricing models that create a “toll” for information sharing. Vendors also should offer alternatives to expensive, labor-intensive workarounds that drain providers’ time and energy.

 

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HL7 Model Identifies Clinical Genomics Workflows, Use Cases

January 16, 2019
by David Raths, Contributing Editor
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Domain Analysis Model covers pre-implantation genetic diagnosis, whole-exome sequencing, RNA sequencing and proteomics

HL7’s Clinical Genomics Work Group has published an HL7 Domain Analysis Model (DAM) to identify common workflows and use cases to facilitate scalable and interoperable data standards for the breadth of clinical genomics scenarios.

The Domain Analysis Model (DAM), which has underdone a rigorous ISO/ANSI-compatible balloting process, covers a myriad of use cases, including emerging ones such as pre-implantation genetic diagnosis, whole-exome sequencing, RNA sequencing and proteomics.

The effort “builds on the DAM Clinical Sequencing work that is already being used to design precision medicine workflows at hospitals across the country,” said Gil Alterovitz, Ph.D., an HL7 Clinical Genomics Work Group co-chair, in a prepared statement. He also serves as a Harvard professor with the Computational Health Informatics Program/Boston Children’s Hospital.

The Clinical Sequencing DAM fueled the design of FHIR Genomics, the subset of HL7’s FHIR standard designed to communicate clinical genomic information. “By extending to broader domains, it can serve as a standard going forward to aid in the design of workflows, exchange formats as well as other areas,” Alterovitz added,

The document presents narrative context and workflow diagrams to guide readers through the stages of each use case and details steps involving the various stakeholders such as patients, health care providers, laboratories and geneticists. This contextual knowledge aids in the development and implementation of software designed to interpret and communicate the relevant results in a clinical computer system, especially a patient's electronic health record.

The HL7 Clinical Genomics Work Group developed several new applications and refinements in the Domain Analysis Model beyond its original scope of clinical sequencing. One notable addition is the analysis of the common workflows for pre-implantation genetic diagnosis (PGD). For those undergoing in-vitro fertilization, advanced pre-implantation genetic screening has become increasingly popular as it avoids the implantation of embryos carrying chromosomal aneuploidies, a common cause of birth defects. Implementers can follow the workflow diagram and see the context for each transfer of information, including the types of tests performed such as blastocyst biopsy and embryo vitrification.

As the clinical utility of proteomics (detecting, quantifying and characterizing proteins) and RNA-sequencing increases, the DAM also outlines clinical and laboratory workflows to capitalize on these emerging technologies.

HL7 notes that future challenges arise from uncertainty about the specific storage location of genomic data, such as a Genomics Archive and Computer/Communication System (GACS), as well as the structure of a patient’s genomic and other omics data for access on demand, both by clinicians and laboratories. Best practices in handling such considerations are being formulated within HL7 and include international input from across the spectrum of stakeholders. In parallel, the HL7 Clinical Genomics Work Group has been preparing an implementation guide for clinical genomics around many of these use cases, to be leveraged alongside the newly published HL7 FHIR Release 4 standard.

 

Related Insights For: Interoperability

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ONC Releases Interoperability Standards Advisory Reference 2019

January 15, 2019
by Heather Landi, Associate Editor
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The Office of the National Coordinator for Health IT (ONC) has released the 2019 Interoperability Standards Advisory (ISA) Reference Edition, which serves as a “snapshot” view of the ISA.

The 2019 Interoperability Standards Advisory represents ONC’s current assessment of the heath IT standards landscape. According to ONC, this static version of the ISA won’t change throughout the year, while the web version is updated on a regular basis. The ISA contains numerous standards and implementation specifications to meet interoperability needs in healthcare and serves as an open and transparent resource for the industry.

The Interoperability Standards Advisory (ISA) process represents the model by which ONC coordinates the identification, assessment, and public awareness of interoperability standards and implementation specifications that can be used by the healthcare industry to address specific interoperability needs including, but not limited to, interoperability for clinical, public health, research and administrative purposes. ONC encourages all stakeholders to implement and use the standards and implementation specifications identified in the ISA as applicable to the specific interoperability needs they seek to address. Furthermore, ONC encourages further pilot testing and industry experience to be sought with respect to standards and implementation specifications identified as “emerging” in the ISA.

The newest ISA reference edition includes improvements made based on comments provided by industry stakeholder during the public comment period, which ended Oct. 1, according to a blog post written by Steven Posnack, executive director of ONC’s Office of Technology, Chris Muir, standards division director, Office of Technology, and Brett Andriesen, ONC project officer. ONC received 74 comments on the ISA this year, resulting in nearly 400 individual recommendations for revisions.

According to the blog post, the ISA contains “a variety of standards and implementation specifications curated by developers, standards gurus, and other stakeholders to meet interoperability needs (a term we use in the ISA to represent the purpose for use of standards or implementation specifications – similar to a use case) in healthcare.”

“The ISA itself is a dynamic document and is updated throughout the year, reflecting a number of substantive and structural updates based on ongoing dialogue, discussion, and feedback,” Posnack, Muir and Andriesen wrote.

The latest changes to the reference manual include RSS feed functionality to enable users to track ISA revisions in real-time; shifting structure from lettered sub-sections to a simple alphabetized list; and revising many of the interoperability need titles to better reflect their uses and align with overall ISA bets practices. According to the ONC blog post, the updates also include several new interoperability needs, including representing relationship between patient and another person; several electronic prescribing-related interoperability needs, such as prescribing weight-based dosing and request for refills; and operating rules for claims, enrollment and premium payments.

The latest changes also include more granular updates such as added standards, updated characteristics and additional information about interoperability needs.

The ONC officials wrote that the ISA should be considered as an open and transparent resource for industry and reflects the latest thinking around standards development with an eye toward nationwide interoperability.

The ISA traditionally has reflected recommendations from the Health IT Advisory Committee and its predecessors the HIT Policy Committee and HIT Standards Committee and includes an educational section that helps decode key interoperability terminology.

 

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