June 30, 2023
Micky Tripathi, PhD, MPP
National Coordinator for Health Information Technology
Office of the National Coordinator for Health Information Technology
U.S. Department of Health and Human Services
330 C Street SW
Washington, DC 20201
Dear Dr. Tripathi,
The National Committee for Quality Assurance (NCQA) thanks ONC for the opportunity to provide feedback on the draft USCDI+ Quality Dataset.
NCQA is a private, 501(c)(3) not-for-profit, independent organization dedicated to improving health care quality through our Accreditation, clinician quality and measurement programs. We are a national leader in quality oversight and a pioneer in digital quality measurement. Leveraging our strengths as a trusted third party, we are committed to helping organizations navigate their journey toward an equitable, digitally enabled health care system. Our mission is to improve the quality of health for all Americans, with an intentional focus on health equity and support for meaningful value-based payment models, propels our daily work.
NCQA agrees with ONC’s goal to create a harmonized dataset for quality-specific data elements to streamline the development and reporting of quality measures and quality-related activities. NCQA intends to leverage the USCDI and USCDI+ Quality datasets in our digital future. The USCDI+ Quality dataset offers the ability to define critical data classes and elements that are being developed for important quality measurement and quality activity domains that are not included in the base USCDI dataset and enhance other data classes for quality use cases; This is essential to NCQA’s work. We believe it is critical to keep USCDI+ Quality dataset consistent and coordinated with the USCDI to ensure alignment of efforts and successful use of the datasets.
We look forward to supporting this important initiative and offer the below comments.
- Level of Completeness: To what extent does the data element list contain a comprehensive list of data elements relevant to measuring quality for important health processes and outcomes? Are there additional data classes and/or elements ONC should consider for inclusion?
- NCQA recommends the USCDI+ Quality dataset builds on the USCDI but does not include duplicative elements that are already in USCDI. Duplication of elements between USCDI and USCDI+ Quality may lead to difficulty keeping datasets aligned as updates are made, and can cause confusion between datasets if there are periods of time with discrepancies. We believe creating the USCDI+ Quality dataset as a parsimonious set of elements critical for quality measurement that build on the USCDI will be most useful for the quality community.
- NCQA also seeks clarification and guidance on if and how the USCDI+ Quality dataset will intersect with regulation. Will ONC define a path for USCDI+ Quality data elements to transition to USCDI, or will there be other regulation associated with the USCDI+ Quality dataset? This pathway will support unlocking true interoperability of quality data.
Data Class Recommendations
- Medication Data Class: NCQA recommends further clarification of data elements to ensure all medication-related elements necessary for quality measurement are included in USCDI+ Quality. Two concepts NCQA believes are critical to clearly define in the USCDI+ Quality dataset are details around Medication Administration and Medication Dispensing. Based on the provided CMS eCQM Use Case mapping, the below identified elements appear to also be CMS needs. NCQA recommends adding these additional elements or clarifying if these concepts are already included in the dataset:
- Medication Dispensing elements:
- Add Medication that was dispensed
- Add date/time medication handed over (When product was given out)
- Medication Administration elements:
- Clarify that the ‘medication administration’ data element is intended to indicate the medication (code) administered
- Add medication administration status data element
- Medication Dispensing elements:
- Cancer Care Data Class: NCQA recommends additional elements in the Cancer Care Data Class related to tumor and genetic testing that are necessary for NCQA measurement use cases. These elements are specified by mCode.
- Add Tumor Marker Test date/time
- Add Tumor Marker Test result (value)
- Add Tumor Marker Test data absent reason
- Add Genomics Report, date/time version made available (Issued)
- Add Genomics Report result, including the genomic variant and genomic region studied
- Care Experience and Outcomes Data Class: Person-centered measurement is a key priority for NCQA. We appreciate the addition of a Care Experience and Outcomes data class. In order to fully leverage person-reported outcome data for quality measurement, we recommend the following:
- Clarify the intent of the data class and constituent data elements. Often, “care experience” refers to survey-generated data, which is distinct from “outcomes data” that is often generated directly from the patient using a standardized instrument or derived from personal medical devices. Therefore, NCQA suggests breaking this data class into three distinct concepts: Care Experience, Patient-Generated Health Data (PGHD) and Patient-Reported Outcomes (PROs). While these concepts often have overlap, in quality there is a need to be able to distinguish between them when necessary or appropriate.
- For a Patient-Reported Outcomes class, we recommend the following specific data elements be added to USCDI+ Quality based on the Patient-Centered Outcomes Research Institute (PCORI) definitions to support person-centered measurement:
- PRO Mode: the person who responded, including the patient (self) or a proxy (for example a parent responding for a child)
- PRO Computer Adaptive Testing (CAT): indicating whether CAT was used to administer the survey or instrument
- PRO Source: Source of the information for the PRO result (for example EHR, claim, survey system)
- Substance Use Data Class: Smoking-related data elements are critical to being able to measure tobacco-use, cessation interventions, and lung cancer screening utilization. The inclusion of smoking status in the USCDI is insufficient for these quality-related activities. We recommend the following are added to the USCDI+ Quality dataset:
- Add pack-years and tobacco quit date
- Procedure Data Class
- Add body site. NCQA leverages this element to support appropriate identification of procedures for quality measurement; based on the provided CMS eCQM Use Case mapping, it appears to also be a CMS need.
- Encounter Data Class: NCQA recommends adding additional data elements to the Encounter Data Class for complete identification of care provided during a specific encounter.
- Add encounter diagnosis elements: clinical status, onset, abatement (resolution)
- Add encounter class element
- Health Insurance Data Class
- Add coverage period. This data element is critical to NCQA identifying appropriate members to be included across all HEDIS quality measures.
- Vital signs Data Class: NCQA recommends expanding this data class to ensure all appropriate vital sign data necessary for quality measurement are available. In addition to each vital sign code, NCQA recommends the following are included for each element:
- Add the result/value
- Add the status
- NCQA also recommends adding Average Blood Pressure data element to USCDI+ Quality if it is not included in the final USCDI v4. Quality measures using blood pressure are considered a high-priority measurement area in many quality and accountability programs, and average blood pressure is important for diagnosing and treating hypertension. It is also recommended for clinical decision making over single readings. We encourage ONC to clarify a standard for calculation. A taskforce led by the American College of Cardiologists and American Heart Association provides guidance for calculating clinician- and self-measured average blood pressure. An average of readings on separate occasions minimizes random error and provides a more accurate basis for estimating blood pressure than individual readings. Average blood pressure is not equivalent to, nor a replacement for, mean arterial pressure. Both are needed to guide clinical care and quality measurement.
- Level of Specificity: Are the data classes and data elements listed in sufficient detail to result in adoption in electronic systems that would make data available for use in quality measures?
- NCQA agrees with the stated concept that the USCDI+ Quality dataset should provide enough detail to explicitly describe priority data structures relevant to quality. We do recommend expanding the descriptions to include data element definitions, similar to what is provided for USCDI elements, to ensure shared understanding of why those elements are included in the USCDI+ Quality realm.
- Usefulness of companion guidance: ONC published the data element list with a complementary crosswalk specific to the CMS quality reporting use case. How useful is this information to individuals who develop and implement measures and FHIR IGs?
- The companion guide provides a useful example of crosswalking data needs for a specific use case. Continued coordination between ONC and HL7, alike to the USCDI and US Core alignment, will support utility of the USCDI+ Quality dataset. ONC may also consider expanding the crosswalk to include other measure concepts beside CMS eCQMs in the future. NCQA has undertaken a similar exercise to identify additional quality measure data elements needs.
- While the companion guide is a useful example of crosswalking data needs, companion guides alone will not propel the quality community to develop and implement aligned and streamlined quality measures referencing FHIR implementation guides. We believe interactive communities that provide space to collaborate, share experiences, and identify best practice can support the overall mission of ONC’s USCDI+ Quality. NCQA is creating a Digital Quality Community for all stakeholders in Digital Measures to have interactive engagement and communication on needs for digital measures. This could include Providers, Health Care Organizations, Health Care IT, Population Health Analytics & Platforms, EHRs and Payers and regulatory organizations.
- Frequency of updates: ONC’s updates to the USCDI and standards advisories typically occur once a year. One goal for USCDI+ is to help stakeholders with tailored needs to establish standardized data sets in a more flexible manner. What frequency of updates to USCDI+ Quality would be useful for achieving this objective?
- NCQA recommends an iterative (more than once a year) initial build phase to develop a robust quality-focused dictionary of elements. Once established, we recommend the update cycle be very closely tied to the USCDI cycle to ensure the two standards remain closely synchronized. The updates should be informed by real-world testing in the community, including Connectathon testing, and the update schedule should be published well in advance to avoid discrepancies between the USCDI/USCDI+ dataset versions as they are concurrently updated.
NCQA thanks ONC for the opportunity to comment on the draft USCDI+ Quality dataset and look forward to continued collaboration on this important effort.
Margaret E. O’Kane