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Regulatory Update

Deep Dive: ONC Draft U.S. Core Data for Interoperability

Published on 1/17/2018

On Jan. 5, 2018, the Office of the National Coordinator (ONC) released two draft documents that promise profound impact on the activities and priorities of Health Information Networks (HINs), provider organizations that participate in them and the vendors that work with both to provide health IT (HIT) services. One draft document deals with the Trusted Exchange Framework Cooperative Agreement (TEFCA), which the 21st Century Cures Act (Cures Act) directed ONC to develop as the guardrails for nationwide health information exchange. The other draft document defines the “what” for exchange by laying out the data classes that are to be exchanged. This second document is the U.S. Core Data for Interoperability (USCDI).

These are both important steps in the right direction, and while TEFCA is important and impacts interoperability, the USCDI draft is equally – or perhaps slightly more – compelling.

Here’s why: The Cures Act defined interoperability, but left open the significant question as to the meaning of “all electronically accessible health information” within that definition. The Cures Act also defined information blocking, but without knowing what is expected for interoperability, we cannot fully understand that definition. Knowing the “what” defines the scope of the consequence of failing to enable exchange of the very data that must be exchanged. The USCDI is a ripe answer for both.

ONC connects the USCDI to the term “electronically accessible health information,” which further associates USCDI to the definition of interoperability. The USCDI identifies the data set expected to be available for exchange and standards for the content and format of that data. The initial USCDI Version 1 (USCDI v1) begins with the Common Clinical Data Set (CCDS), as required by the 2015 Certification Criteria Edition created by ONC, and adds two new data classes: Clinical Notes, both structured and unstructured; and Provenance, which, at a high level, is metadata used as an audit trail to identify the source of the data.

The current v1 draft defines what is minimally required for exchange right out of the gate under TEFCA, once finalized. The USCDI outlines a progression in the data set to include more data, categorizing additional data classes being considered as “candidate” and “emerging” data as ONC’s roadmap for future expansion of the USCDI. Based on this, it appears ONC recognizes both the current state of information exchange and electronically accessible health information, and the need to progress over time to a “complete” data set as envisioned in the Cures Act.

What USCDI could mean

The USCDI is currently only in draft state and only connected to TEFCA, so items in this section are potential and probably implications of the USCDI. These projections are not required by the USCDI itself.

As noted above, USCDI is being associated with the term interoperability to define what electronic data should be accessible and able to be exchanged under the Cures Act. Based on this, the USCDI can be considered a floor as to what electronic health data should be accessible and exchangeable and how that should occur. Starting from that point, and an assumption that ONC will utilize resources already available (such as the USCDI) we could connect USCDI to the definition of information blocking. If the USCDI is a floor as to what electronic health data should be available for exchange, then failing to provide that data in the required format upon request through the TEF may be considered information blocking.

The terms “information blocking” and “interoperability” under the Cures Act both apply to all “health care providers.” This pushes the requirement to meet USCDI availability to all providers in all venues of care.

Though the USCDI is rooted to the CCDS in the 2015 certification edition created by ONC, it is not bound by it. The use of CEHRT provides a solid base and will be required by several programs, namely meaningful use (MU) and the Merit-based Incentive Payment System (MIPS), and therefore will be in wide use by participants in those programs. There are new data classes being considered for inclusion in future versions of USCDI, potentially as soon as 2019, that are beyond the realm of the 2015 certification edition, further extending USCDI beyond the scope of CEHRT.

The USCDI should be considered as a potential source of requirements for all health care providers using HIT, their vendors and their HINs. Those participating in the use of CEHRT for specific programs will likely be in the best position to initially meet these requirements. However, TEFCA reaches all provider venues where HIT is in use, and so extends beyond the programs that currently require use of CEHRT for Medicare and Medicaid. There are quite a few health care organizations that use HIT, yet have not been required to be on a certified system to this point. Those organizations may now be required to meet equivalent, or in some cases more stringent, requirements and standards for data availability.

The USCDI does contain a phase-in of data availability, moving from v1 to larger data sets over time, however there is not a phase-in process for the USCDI as a data set for different venues of care as a floor for interoperability. The timing of adoption for USCDI versions, will likely be phased in at the same time for all providers based on the program or rule requiring USCDI. TEFCA does not contain a phase-in for requiring USCDI. Another program or requirement, such as the information blocking rule, could utilize the USCDI data set for its use as well. Since the proposed rule from ONC on defining what makes for information blocking and what constitutes reasonable practices for health information exchange will not be released until later this year, it cannot be definitively said the USCDI will be required.

While this makes sense in the support of interoperability, it begs the question: Will everyone be ready?

What USCDI doesn’t mean

While it is a good compliance practice for health care organizations to take proposed rules and draft requirements to their potential end when considering comment on public policy development and its various impacts and requirements, it is equally important to call out limitations on what the proposals do not do.

USCDI is a standard data set with supporting specifications and standards found within certification and within ONC’s Interoperability Standards Advisory. Though it may be considered a floor and become part of the determination of what operationalizes information blocking, it does not add any requirement to document information in an electronic health record or other HIT product.

The USCDI is built on the presumption that if the information is available in an electronic format, then the USCDI should be available – and if exchanged under TEFCA – in a required standard. These standards may be extended to information blocking, but we will need to see more to know for sure. TEFCA and USCDI contain, in themselves, no requirement for health care organizations to use an electronic system or to use CEHRT. However, programs requiring exchange under TEFCA or use of USCDI may have an equal or larger impact in the long run.

Looking forward

As more health care organizations understand the USCDI’s requirements and implications, their to-do lists will grow. A hospital or health system’s ability to meet the USCDI requirements based on the included data classes should be assessed. Gaps discovered in the assessment process should be evaluated to determine if and how they can be corrected.

Over the course of 2018, the ONC will release more rules impacting interoperability. This will include the information blocking rule and a new certification rule, likely expanding the certification program with new criteria (but not replacing the 2015 edition entirely). This is an exciting time for the industry, where interoperability will not look the same at the end of 2018 as it did at the first of the year.

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