Monday, July 18, 2016

Solving 2015 Edition Certification: CCDA and Common Clinical Data Set

ONC's 2015 Edition Health IT Certification Criteria mark the latest chapter in the certification process for health information technology. The roster of measures was made effective on January 14, 2016, and the certification testing process has begun in earnest. 

Despite the flurry of activity around 2015 Edition, it should be noted that there is not yet an expiration date for 2014 Edition testing, which is expected to continue through the end of FY 2017. 

While vendors are not under immediate deadline, it is highly useful to adopt and certify, at minimum, the functionality that is relevant to your user base. There are a number of early adopter advantages, including the delivery of more interoperable software to users. Now that the all-or-nothing "Complete EHR" certification is gone, developers may choose to focus "Base EHR" measures and/or those needed for their uses to meet Meaningful Use and/or other user objectives.

The 2015 measures mark a significant overhaul to the previous 2014 Edition regulations. A look at some of the major changes in the 2015 measures gives us a signal of where the industry is headed (or at least where it thinks it's going).

General themes
As Keith Boone pointed out, 2015 Edition represents a pivot “from EHR focus to Health IT focus.” ONC intends to make its Certification accessible to a broader range of health IT applications than simply those directly in line with the CMS EHR Incentive Programs, while attempting to galvanize broader interoperability.

This rationale is behind retiring the “Complete EHR” certification in 2015 Edition. It’s also why ONC has swapped out the term “EMR” for “health IT,” renamed the Common MU Data set the “Common Clinical Data Set” and provided more incentives for vendors to give patients access to their data using methods outside the traditional medical record, such as APIs and non-encrypted email.

ONC is also attempting to address health disparities by capturing more categories of race and ethnicity in EMR systems and there has been reaffirmation of the importance of privacy and security in the updated measures.

The Consolidated Clinical Document Architecture (C-CDA) format remains vital to ONC's efforts to foster interoperability and data integrity. 

To that end, C-CDA requirements have seen a major update in 2015 Edition. Vendors must support both v1.1 and v2.1 releases – and the latter must be backwards compatible. ONC is providing a “gold standard sample document” available to assist with adoption and has provided a "sandbox" of C-CDA resources, including a tool for vendors can test against the standard with a web-based scorecard

There are 3 C-CDA templates that must be supported for transition of care:
  • CCD
  • Referral Note
  • Discharge Summary (Inpatient Only)
Health IT must also support the number of preferences for display and usage of CCDA, including:
  • Display only a particular section (or sections) at a time
  • Display order
  • Number of initial sections to display
Common Clinical Data Set (CCDS)
Formerly known as the Common MU Data Set, the CCDS is a series of data stipulated for use across the 2015 Edition measures. ONC has provided a useful crosswalk, comparing the 2014 Common MU Data Set with its new incarnation.

Common Clinical Data Set is comprised of data from standards adopted by ONC, such as the CDC Race and Ethnicity Code Set Version. It is explicitly referenced in the following measures, often as a baseline that the certifying technology must receive, send out and/or make viewable:
  • § 170.315(b)(1): Transitions of Care
  • § 170.315(b)(4): Common Clinical Data Set summary record – create
  • § 170.315(b)(5): Common Clinical Data Set summary record – receive
  • § 170.315(b)(6): Data export
  • § 170.315(e)(1): View, download, and transmit to 3rd party
  • § 170.315(f)(5): Transmission to public health agencies – electronic case reporting
  • § 170.315(g)(6): Consolidated CDA creation performance
  • § 170.315(g)(8): Application access – data category request
  • § 170.315(g)(9): Application access – all data request

Stay tuned for more information on new CQM requirements and their implications for population health monitoring!

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