HHS Releases Draft Trusted Exchange Framework with Eyes on Creating “Network of Networks” Infrastructure | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

HHS Releases Draft Trusted Exchange Framework with Eyes on Creating “Network of Networks” Infrastructure

January 5, 2018
by Rajiv Leventhal
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The Framework, which will be open for comment for 45 days, will be facilitated by a recognized coordinating entity that will be selected via an application process

The Department of Health and Human Services (HHS) has released the draft Trusted Exchange Framework, as required by the 21st Century Cures Act of 2016. Federal health IT officials call the Framework “a significant step towards achieving interoperability.”

In the 21st Century Cures Act (Cures Act), Congress identified the importance of interoperability and set out a path for the interoperable exchange of electronic health data. Specifically, Congress directed ONC (the Office of the National Coordinator for Health IT) to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.”

The draft Trusted Exchange Framework, released on Jan. 5, 2018, outlines a common set of principles for trusted exchange and minimum terms and conditions for trusted exchange. This is designed to bridge the gap between providers’ and patients’ information systems and enable interoperability across disparate health information networks (HINs), according to ONC officials.

According to the announcement today, the Trusted Exchange Framework “proposes policies, procedures, and technical standards necessary to advance the single on-ramp to interoperability requested by Congress.” And it will be “facilitated through ONC in collaboration with a single recognized coordinating entity (RCE) to be selected through a competitive process.”

The RCE will use the Trust Exchange Framework policies, procedures, technical standards, principles, and goals to develop a single Common Agreement that qualified health information networks and their participants will voluntarily agree to adopt. Following a 45-day public comment period and refinements to the draft document, a final draft of the combined Trusted Exchange Framework and Common Agreement will be released. The Trusted Exchange Framework and Common Agreement (TEFCA) will be published in the Federal Register in 2018, according to officials.

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What’s more, the draft Trusted Exchange Framework would not prevent existing or new organizations from creating point-to-point or individual agreements between organizations that have a particular business need to exchange information—while preventing potential information blocking—that may be different from those outlined in the proposal, according to officials.

On a call with members of the health IT media today, Don Rucker, M.D., National Coordinator for Health IT, and Genevieve Morris, Principal Deputy National Coordinator, said that they expect a number of submissions for the RCE and that experience in building cooperative agreements and having an understanding of governance principles will be key for whoever is selected.

When asked if the RCE will specifically have a “policing” role, Rucker said that the oversight will be more about coordinating than policing. “It’s not dissimilar from network governance [in other industries]. A lot of it is general governance,” he said, noting that “most folks have an incentive to participate.” However, ONC’s Morris did add that the RCE will have a responsibility to oversee security in the network, dealing with data breaches if they were to happen, and having processes in place for dealing with bad actors. More broadly, the RCE will be tasked with operationalizing the Trusted Exchange Framework.

To this point, Rucker went on to say that, as outlined by Congress, one of the core interoperability provisions in the Cures legislation was to create a “network of networks” in which regional health information exchanges (HIEs) that have been around for a while, and that move similar sets of health data around, would become connected to one another. “The goal of Congress in [the health IT section of Cures] was that ONC would work to provide what Congress framed as ‘a common agreement in these networks.’ So this brings us immediately to what is potentially very challenging in interoperability. It’s a national challenge and it hasn’t been easy. Folks have made great progress but there is lot of work to be done,” he said.

As such, one approach to solving this problem is this Trusted Exchange Framework. “This is a network-facing issue,” noted Rucker, adding that the Cures Act also includes other interoperability approaches, such as emphasizing the use of APIs [application programming interfaces]. Rucker contended that these approaches can be viewed as “complimentary” and that ONC is currently working on rulemaking for open APIs and for information blocking.

Historically, said Rucker, interoperability has been thought of in a very narrow context, such as provider-to-provider, but now, Congress is looking at it with a broader perspective that includes factors such as patients being empowered and shopping for their own care. “These broader [use] cases can bring in capital and new investments and make [interoperability] more robust,” he said.  Rucker added, “Getting this larger coordination is an opportunity to allow the current participants to expand the scope of their services. That’s the unambiguous desire of Congress.”


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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.

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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. 

Email:  zabrina.gonzaga@lantanagroup.com

Twitter: @lantana_group

 


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Health IT Now Pushes for Information Blocking Regulation, Says Administration “Must Uphold its End of the Bargain”

September 13, 2018
by Rajiv Leventhal, Managing Editor
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The executive director of Health IT Now, a coalition of healthcare and technology companies, is again criticizing the Trump administration for not yet publishing any regulation on information blocking, as required by the 21st Century Cures Act legislation.

In an op-ed published recently in STAT, Health IT Now’s Joel White wrote, “More than 600 days after the enactment of the Cures Act, not a single regulation has been issued on information blocking.” White added in frustration, “Health IT Now has met with countless officials in the Trump administration who share our commitment to combat information blocking. But those sentiments must be met with meaningful action.”

The onus to publish the regulation falls on the Office of the National Coordinator for Health IT (ONC), the health IT branch of the federal government that is tasked with carrying out specific duties that are required under the 21st Century Cures Act, which was signed into law in December 2016. Some of the core health IT components of the Cures legislation include encouraging interoperability of electronic health records (EHRs) and patient access to health data, discouraging information blocking, reducing physician documentation burden, as well as creating a reporting system on EHR usability.

The information blocking part of the law has gotten significant attention since many stakeholders believe that true interoperability will not be achieved if vendors and providers act to impede the flow of health data for proprietary reasons.

But ONC has delayed regulation around information blocking a few times already, though during an Aug. 8 episode of the Pulse Check podcast from Politico, National Coordinator for Health IT Donald Rucker, M.D., said that the rule is "deep in the federal clearance process." And even more recently, a bipartisan amendment to the U.S. Senate's Department of Defense and Labor, Health and Human Services, and Education Appropriations Act for Fiscal Year 2019 includes a requirement for the Trump administration to provide Congress with an update, by September 30.

White, in the STAT piece, noted a June Health Affairs column in which Rucker suggested that implementation of the law’s information blocking provisions would occur “over the next few years.” White wrote that this is “a vague timeline that shows little urgency for combating this pressing threat to consumer safety and stumbling block to interoperability.”

Health IT Now is not alone in its belief that the rule should have been published by now, nor is it the first time the group is bringing it up. Last month

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By the end of this year, ONC’s implementation and interpretation of data blocking will also be published and available for comment, as was the case with the TEFCA proposed rule. The TEFCA final rule is also anticipated by the end of 2018.

HOWEVER…there’s still time to prepare for TEFCA and the data blocking regulation, and final rules for both in the coming months will set concrete timelines, and for TEFCA it will be interesting to see how ONC reacts to stakeholder comments, internal and external.

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