In April of 2023, the Office of the National Coordinator for Health Information Technology (“ONC”) released another proposed update to the 21st Cures Act that established not only new conditions and requirements for certified health IT under the ONC’s Health IT Certification Program but also updated certain existing certification criteria, and more notably for the purposes of this blog post, established a new baseline version for the United States Care Data for Interoperability (“USCDI”).
The USCDI is a standardized set of health data classes and corresponding elements established by the ONC’s Interoperability Standards Advisory (“ISA”) to streamline and normalize the data standards and implementation specification for healthcare data used for any clinical health IT interoperability purposes. While the USCDI standards are leveraged primarily by ONC to further its certified health IT program requirements, they are also utilized in other interoperability regulations. For example, in December of 2022, the Center for Medicare and Medicaid Services (“CMS”), in an update to its Interoperability and Patient Access regulation, re-defined “clinical” data required to be made available via the mandated Patient Access and Payer to Payer APIs to align to those data elements outlined in the then current USCDI standard. Today, the current USCDI standard mandated by regulation is Version 1, but per the terms of the most recent ONC proposed update, as of January 1, 2025, the required standard is not just for certified health IT but also for the CMS-mandated patient access, provider access, and payer to payer on FHIR exchange APIs, respectively, will be Version 3.
The following list provides a high-level summary of the changes:
- Expansion of the Assessment and Plan of Treatment, Goals, Problems, and Procedures data classes to include Social Determinants of Health (“SDOH”) elements that collectively identify the conditions in which people live, learn, work, and play and the impact of those conditions on the individual’s health. The following data elements are added to each of the aforementioned classes: SDOH Assessment; SDOH Goals; SDOH Problems/Health Concerns; and SDOH Interventions.
- Expansion of the Care Team Member class to include additional elements that provide more information concerning each person who participates, or is expected to participate, in the care of an individual and has a name, identifier, role, location, and phone number.
- Expansion of the required data under the Discharge Summary Note element under the Clinical Notes data class to include admission and discharge dates and locations, discharge instructions, and reasons for hospitalization. In addition, the Imagining Narrative, Laboratory Report Narrative, and Pathology Report Narrative data elements have been removed from the Clinical Notes class.
- Creation of a new Clinical Tests data class to enable the capture and exchange of non-imaging, non-laboratory clinical tests. The Clinical Tests data class contains two elements – Clinical Tests and Clinical Tests Results/Report
- Creation of a new Diagnostic Imaging data class to enable the capture and exchange of structured and unstructured imaging test and report data. The Diagnostic Imaging data class contains two elements – Diagnostic Imaging Tests and Diagnostic Imaging Reports.
- Creation of a new Encounter Information data class to provide additional information on interactions between a provider and the individual and includes the following information for each encounter – Type, Diagnosis, Time, Location, and Disposition
- Creation of a new Health Insurance Information data class to allow for the capture and exchange of relevant insurance coverage information in support of a variety of purposes including, but not limited to, patient matching and record linkage, coverage determination, prior authorization; price transparency; and improving claim reimbursement efficiency. Data elements covered under this class include Coverage Status, Coverage Type, Relationship to Subscriber, Member Identifier, Subscriber Identifier, Group Identifier, and Payer Identifier.
- Creation of a new Health Status Assessments data class to allow for the capture and exchange of data related to assessments of health-related matters that better enable the individual’s healthcare providers to identify and address certain conditions readily. Data elements under this class include Disability Status; Mental and Cognitive Status; Functional Status; Pregnancy Status; Health Concerns; and Smoking Status.
- Expansion of the Laboratory data class to include the following data elements in support of ongoing public health needs – Specimen Type and Results Status.
- Expansion of the Medication data class to include the following data elements supporting CMS reporting requirements: ONC Certification criteria – Dose; Dose Units of Measure, Indication, and Fill Status.
- Expansion of the Patient Demographics and Information class to include net new data elements to support public health use cases and care coordination efforts. Such new data elements include Sexual Orientation and Gender Identity, designed to standardize data exchange and ensure more inclusivity; Related Person’s Name and Related Person’s Relationship, added to enable linkages between maternal and children records and linking other related persons; Date of Death, added to support patient matching, adverse events, public health, and additional vital reporting; Occupation and Occupation Industry, added to support public health initiatives and to effectively capture military service; and lastly, Tribal Affiliation, added to aid in determinations of eligibility, care coordination efforts across non-tribal facilities, and identification of disparities in healthcare across American Indian and Alaska Native populations.
- Expansion of the Problems data class to include Date of Diagnosis and Date of Resolution data elements to support timing for recorded and maintained problem lists within the provider’s electronic health record or other similar tools.
- In addition to as set forth above for SDOH data elements, expansion of the Problems data class to include the Reason for Referral data element in support of the care certification criterion under the ONC’s health certification process.
As evidenced by the preceding list, a majority of the changes can be bucketed into two broader categories – additional classes or elements to support improved care coordination across providers, payers, and other organizations or persons involved in the care of individuals and additional classes or elements to support public health related purposes and initiatives – with many of the additional classes and elements falling into both. For example, the addition of SDOH data elements across multiple data classes, the expansion of the data elements in the Patient Demographics and Information data class, and the inclusion of the Health Assessment data class provide a more robust emphasis on data elements that relate to situations or circumstances that while not be directly related to an individual’s physical health, could have a material impact or be a contributing factor, to an existing or future condition. Similarly, the additional elements to the Care Team data class, along with the addition of the Encounter Information and Health Insurance Information data classes, respectively, when viewed in conjunction with existing elements further support more effective care coordination by ensuring that each member of the individual’s care team is identified and that any relevant information regarding the individuals care, or payment thereof, is made accessible.
While the USCDI standard is inherently designed to evolve with the industry and its needs, an interesting question arises with respect to what is actually triggering the evolution – the standard or the industry. For example, many of the SDOH data elements referenced above were added in the Version 2 draft released in July 2021. Since then, we have seen more emphasis on SDOH elements in other contexts, such as in the Request for Information in the updated CMS proposed rule in December of 2022, which sought input on how best practices for collecting and exchanging SDOH data, as well as in the new ACO Reach Program that officially replaced the current Global and Professional Direct Contracting (“GPDC”) model in January of 2023, which has a targeted focus on bringing the benefits of accountable care to underserved communities by advancing health equity. While it’s unclear which of the previous came first, it is evident that proposed updates to the USCDI standard are excellent indicators of what is to come from a regulatory perspective and are worth paying attention to. The next proposed update is slated for July 2023 and should hopefully provide some insight into what is on the regulatory docket for 2023 and 2024.