The undersigned members of the Physician Clinical Registry Coalition (“Coalition”) appreciate the opportunity to provide feedback on the draft data element list for United States Core Data for Interoperability Plus (“USCDI+”) Quality. The Coalition is a group of medical society-sponsored clinical data registries that collect and analyze clinical outcomes data to identify best practices and improve patient care. We are committed to advocating for policies that encourage and enable the development of clinical data registries and enhance their ability to improve quality of care through the analysis and reporting of clinical outcomes.

We applaud the Office of the National Coordinator for Health Information Technology (“ONC”) for taking steps to develop a framework to provide a predictable, transparent process for evaluating and categorizing data elements for the purpose of exchanging and using data for quality measurement and measure development. To further promote transparency, we encourage ONC to clarify how it selected the data elements under consideration. This information would aid registries in better understanding ONC’s data element priorities.

We also encourage ONC to view specialty societies and their registries as valuable, collaborative partners when refining and implementing USCDI+ Quality. Registries can facilitate the purpose USCDI+ Quality by highlighting core data elements that must be evaluated in order to improve the quality of care. As federal agencies increasingly rely upon specialty-specific quality reporting, ONC must ensure that its data elements and classes reflect quality metrics relevant to clinical data registries and their associated specialties. To that end, we offer the following comments and recommendations.

Level of Completeness and Specificity

The Coalition urges ONC to expand the draft data element list to ensure that it contains data elements that are relevant to measuring quality for health processes and outcomes. As a general matter, the draft data element list for USCDI+ Quality does not contain a sufficient number of specialty-specific data elements. For instance, the draft list does not include any data elements regarding the mental health of the patient. Even in the existing data classes that are specialty-specific (e.g., Cancer Care), the draft data elements do not fully capture the nuances involved with this specialty practice. As an example, the Cancer Care data class does not contain the entire Minimal Common Oncology Data Elements (“mCODE”) Primary Cancer profile with all its corresponding data elements, including Histology/Morphology/Behavior data element that describes the morphologic and behavioral characteristics of the cancer to accurately capture the complete cancer diagnosis. We encourage ONC to work with specialty societies that sponsor clinical data registries to identify core data elements that are meaningful for each specialty.

Further, there is a dearth of patient-reported data elements currently in the draft list. For example, only two of the five EuroQol-5D (“EQ-5D”) health-related quality of life measures are included in the draft data element list. It is unclear why ONC included mobility and self-care in the draft list but excluded the usual data elements of pain/discomfort and anxiety/depression measures.

We urge ONC to consider the following data elements for inclusion in the data element list for USCDI+ Quality:

• Medication Treatment Intent: Under the Medications data class, ONC should consider adding a data element to describe the overall intention of the treatment (e.g., prophylactic, supportive, curative, etc.).
• Medication Order: This data element would be useful to specialties such as emergency medicine that may employ various testing to screen patients for conditions.
• Medication Termination Date: This data element would allow for the reporting the date of an unplanned or premature medication termination.
• Medication Termination Reason: This data element would provide the reasons for terminating a course of medication.
• Unique Device Identifier - Implantable: To aid in the monitoring and evaluation of devices, it is critical to include the device identifier. It appears the device identifier was included in USCDI v.4, but it was not selected for USCDI+.
• Medical Specialty: It is critically important to easily identify the specialty of the treating physician. This data element under the Encounter Information data class would allow quality metrics specific to a specialty to be extracted accurately and consistently across platforms.
• Asserted Date: Under the Problems data class, ONC should add a data element to record the date on which the existence of the condition was first asserted or acknowledged.
• Verification Status: ONC should add a data element to record the verification status of a clinical condition. This data element would fall under the Problems data class.
• Date of Death: To facilitate the end-of-life measures in federal programs, we urge ONC to add a data element under the Patient Demographics data class that records the patient’s date of death.

Lastly, ONC should publish a comprehensive list of data elements, referencing both the data elements’ technical specifications and instructions for their implementation.

Usefulness of Companion Guidance

The crosswalk specific to the quality reporting use case assists measure developers in understanding how a particular data element is used in a measure within a reporting program administrated by the Centers for Medicare and Medicaid Services (“CMS”). However, we encourage ONC to work with stakeholders to provide less prescriptive examples of how the data elements are used.

Frequency of Update

To ensure optimal utilization of the revised data elements, we recommend that ONC organize its annual USCDI updates schedule in conjunction with the release of updated electronic clinical quality measures specifications for CMS programs.

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The Coalition appreciates your consideration of our concerns and recommendations. If you have any questions, please contact Rob Portman or Leela Baggett at Powers Pyles Sutter & Verville, PC (Rob.Portman@PowersLaw.com or Leela.Baggett@PowersLaw.com).

Respectfully submitted,

American Academy of Ophthalmology
American Academy of Otolaryngology–Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association of Neurological Surgeons
American College of Emergency Physicians
American College of Gastroenterology
American Psychiatric Association
American Society for Gastrointestinal Endoscopy
American Society of Anesthesiologists
American Society of Plastic Surgeons
American Urological Association
College of American Pathologists
Congress of Neurological Surgeons
Society of Interventional Radiology
Society of NeuroInterventional Surgery
The Center for Professionalism and Value in Health Care
The Society of Thoracic Surgeons