The proposed rules on interoperability released earlier this year by the Office of the National Coordinator (ONC) and Centers for Medicare & Medicaid Services (CMS) have generated a lot of industry chatter.
More than 1,000 organizations submitted comments addressing the draft rules, which many believe are very ambitious in scope. While the two regulatory bodies have much to consider, one thing is certain: the final rules will create a new paradigm for health data management and governance in today’s healthcare organizations that is intended to improve interoperability and empower patients.
A recent webinar hosted by Health Data Management—Investing for the Future: The ONC & CMS Proposed Rules on Interoperability—explored the critical elements in the proposed rule and how they could impact payers, providers, and health IT vendors. Mark Fuchs, director of market research for Wolters Kluwer Health Language Solutions and Bob Hussey, founder and principal of RGH Health Consulting, LLC, reflected on the industry’s goals in advancing access to data and interoperability and the steps payers and providers can take to prepare and invest in their data today.
The proposed interoperability rules: A closer look
Bob explained that the HITECH Act and 21st Century Cures Act provided the backdrop for the proposed rules. Enacted in 2009, the HITECH Act spurred widespread adoption of electronic medical records but failed to promote the widespread interoperability that would enable broad exchange of health data. To remedy this shortfall, Congress passed the 21st Century Cures Act in 2016, which paved the way for the proposed rules implementing the Interoperability, Open API, and Information Blocking provisions of 21st Century Cures.
Within the proposed rules, Bob noted that the provisions most relevant to data management and governance include:
1) open application programming interface (API) criteria for patient and population services
2) United States Care Data for Interoperability Criterion (USCDI)
3) electronic health information (EHI) export criteria.
Bob explained that the ONC draft rule introduces broader API criteria and proposes use of FHIR as the API standard—a move that has broad support across the industry. The proposed ONC rule replaces use of the Common Clinical Data Set with an expanded USCDI and EHI criterion. Bob explained that the broad definition of EHI—relating to the past, present, or future health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual—has received significant pushback from various stakeholder groups concerned about the scope of the definition.
In addition, Bob highlighted the ban on information blocking as a key provision impacting data governance. Information blocking is defined as “a practice by a health care provider, health IT developer, health information exchange, or health information network that, except as required by law or specified by the Secretary as a reasonable and necessary activity, is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” Failure to comply with the ban can result in fines of up to $1 million per incident.
Impact to payers, providers and patients
Mark noted that comments from stakeholders suggest general acceptance of the USCDI, although he believes that many industry groups have missed the significance of the subtle but nuanced definition of EHI and its potential impact. Specifically, Mark noted that one of the two new data elements, clinic notes, will prove to be a game-changer for bringing in more clinical data that can be turned into information that improves quality measures reporting, risk adjustment, and social determinants of health while ensuring context and transfer of care.
In addition, USCDI’s focus on use of specific terminology standards for each data element is expected to improve semantic interoperability across the industry, supporting the highest level of data exchange that is meaningful and actionable to stakeholders. Mark emphasized that payers and providers will need to prepare for greater use of IT standards such as SNOMED CT and LOINC as well as FHIR and open API protocols. From a data governance perspective, this will require the deployment of more comprehensive reference data management strategies, more refined data normalization procedures, and the ability to extract free text.
The impacts of the proposed rules and USCDI on patients is expected to be significant as well. Mark noted that they will gain greater control of their healthcare data and its value, opening new avenues to work with clinical studies and other research outlets and allowing for smoother transitions between providers and payers. He suggested that patients also gain more control over "who is seeing what" when it comes to their health records and information.
Next steps: Improving clinical data management
The industry should begin preparing now for the opportunities and challenges the proposed rules will introduce. The rules will introduce greater possibilities for combining structured and unstructured data and will allow healthcare organizations to draw on the power of advanced technologies like artificial intelligence, machine learning and natural language processing (NLP) to improve clinical data management.
Laying the right foundation for these activities is critical, and clinical and financial leaders should ask key questions such as: Is data normalized to the right industry standards? Can data be accessed via FHIR? Will patients and members be able to use their data? Can our organization fully leverage its information assets?
As part of setting up a comprehensive data governance strategy, it’s also recommended that stakeholders consider the advantages of a third-party partner like Wolters Kluwer to accelerate the generation of accurate data through its Health Language solutions and support team. The Health Language platform comprehensively addresses data quality via a three-pronged approach: a Reference Data Management platform that automates the roadmap to a single source of truth for reference terminologies; Interoperability and Data Normalization Solutions that assist with consolidation and standardization of data; and a Clinical NLP solution for extracting information from unstructured text.
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