On behalf of the CARIN Alliance, we want to thank the Office of the National Coordinator for Health Information Technology (ONC) staff for the opportunity to comment on the United States Core Data for Interoperability Plus (USCDI+) Quality - Draft Data Element List.

As you are aware, the CARIN Alliance is a multi-sector group of stakeholders representing numerous hospitals, thousands of physicians, and millions of consumers and caregivers and an HL7 FHIR Accelerator program. We are committed to providing consumers and their authorized caregivers access to health information. Specifically, we are promoting the ability for consumers and their authorized caregivers to gain digital access to their health information via the open APIs and the ability to use that information in any third-party application they choose. 

The CARIN Alliance developed the Common Payer Consumer Data Set (CPCDS) an agreed upon set of data fields to exchange with consumers (similar to ONC 2015 Edition Common Clinical Data Set) and the CARIN IG for Blue Button, a FHIR-based implementation guide for health plans and consumer facing applications to use to implement the API to answer the challenge for health plans to ‘meet or exceed’ the CMS Blue Button 2.0 capabilities. The STU1 version of the IG was published in November 2020 and the STU2 version was published in November 2022.

The CARIN Alliance previously submitted new Data Class and Element recommendations for USCDI version 2, 3, and 4 suggesting the inclusion of core administrative data found in the CPCDS and CARIN IG for Blue Button that did not exist in the USCDI, but are necessary to further the ONC’s mission of “a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange.” Many of the submitted Data Element recommendations have been included within the Health Insurance Information and Patient Demographics/Information Data Classes in USCDI v3 or v4, however the Explanation of Benefits (EOB) Data Class and Data Elements associated with the CARIN IG for Blue Button were not included as part of USCDI v3 and were instead added to the ONC USCDI Comment level.

As we suggested in September 2021, April 2022, and September 2022 these Data Elements are required to meet the CMS Advancing Interoperability and Improving Prior Authorization Processes Rule.[1] In fact, CMS Blue Button has adopted the CARIN IG for Blue Button for all Medicare FFS beneficiaries[2] and so have more than 90 percent of all CMS payers across the country (https://www.cmscompliancetracker.com/).

These Data Elements are critical to the implementation of the CARIN IG for Blue Button. Furthermore, adding the Data Elements associated with the CARIN IG for Blue Button to the USCDI and to USCDI+ will provide the much-needed direction everyone in the health care ecosystem needs to include financial and administrative data in their technology roadmaps to support multi-sector interoperability. Moreover, these Data Elements are already made available by electronic health record vendors[ including Epic (see https://fhir.epic.com/Specifications?api=1072|https://fhir.epic.com/Specifications?api=1072] and https://fhir.epic.com/Specifications?api=1073) as early as May 2020 and as part of the CMS data at the point of care pilot (https://dpc.cms.gov/) that was launched in July 2019.

We recommend that USCDI+ Quality adopt many of the Data Elements that are required by the CARIN IG for Blue Button including the Explanation of Benefits (EOB) Data Class and Data Elements included at the USCDI Comment Level. We believe these Data Elements demonstrate extensive existing use in systems and exchange between systems and as part of multiple use cases that show significant value to current and potential users and should be included in both USCDI and USCDI+.

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Level of Completeness

In reviewing the USCDI+ Quality Data Element List, we found several discrepancies that we wanted to highlight for ONC. We believe that for a mapping tool to be useful, they need to be very accurate and hope that by bringing these to the attention of ONC, they might be helpful.

As an example, the current USCDI+ Quality Data Element List has several discrepancies as to which version of USCDI is used, which could result in challenges for implementers trying to identify which version to use. We recommend that the USCDI+ Quality Data Element List point to the most recent version of USCDI to reduce the burden of reviewing multiple versions of USCDI.

Note: The recommendations below are not an exhaustive list and do not include all Data Classes or Data Elements.

 

Health Insurance Information

1. The Draft USCDI+ Quality Data Class is listed as both Health Insurance and Health Insurance Information. We recommend that the USCDI+ Quality Data Element List be updated to use Health Insurance Information to mirror the name in USCDI v4.
2. For Data Elements that have already been included in a published version of USCDI, we recommend that USCDI+ point to the latest version of USCDI, as appropriate. As an example, the Payer Identifier and Coverage Status Data Elements point to USCDI v3. While this was the first version of USCDI where these profiles were added, we believe that USCDI should point to the latest version, which in this case is draft USCDI v4 version. One reason this is helpful is that Data Element names can change between versions (e.g. Birth Sex USCDI v1, Sex (Assigned at Birth) v2, Sex v3 and v4).

 

Patient Demographics/Information

1. The Data Element Deceased does not appear in Level 2 of USCDI.
2. The Data Element Zip Code is included, but no other address information is included. We recommend that Current Address or Previous Address be added and that it reflects the latest version USCDI v4, which references US@ Technical Specification for Patient Addresses, Final Version 1.0.
3. The Data Element Birth Sex is included and referenced as USCDI v3, however the Data Element in USCDI v3 is Sex. The Data Element was named Birth Sex in USCDI v1, then modified to Sex (Assigned at Birth) in USCDI v2 and finally changed to its current name Sex in USCDI v3. We recommend that ONC modify the Data Element to Sex to correspond to the name in USCDI v4.
4. The Data Element Race in USCDI+ references USCDI v3, but this has been a Data Element since USCDI v1. We recommend that ONC modify the USCDI+ Quality Data Element List reflect the latest version USCDI v4.
5. The Data Element Ethnicity in USCDI+ references USCDI v3, but this has been a Data Element since USCDI v1. We recommend that ONC modify the USCDI+ Quality Data Element List reflect the latest version USCDI v4.
6. The Data Element Gender in USCDI+ references USCDI v3, but this has been a Data Element since USCDI v2 and is named Gender Identity. We recommend that ONC modify the USCDI+ Quality Data Element List to Gender Identity and the USCDI version to reflect the latest version USCDI v4.

 

Procedures

1. The Data Element Procedure Type points to USCDI v1 within the Procedures Data Class. We recommend that this Data Element refer to the Comment section of USCDI v3 under the Explanation of Benefit Data Class.
2. We recommend that ONC modify the USCDI+ Quality Data Element from Status to Procedure Status to reflect the name in the Comment.
3. We recommend that ONC modify the USCDI+ Quality Data Element from Location to Location of Procedure to reflect the name in the Level 2.

 

Encounter Information

1. We recommend that ONC modify the USCDI+ Quality Data Element from Time to Encounter Time to reflect the name in the latest version USCDI v4.
2. We recommend that ONC modify the USCDI+ Quality Data Element from Type to Encounter Type to reflect the name in the latest version USCDI v4.
3. We recommend that ONC modify the USCDI+ Quality Data Element from Diagnosis to Encounter Diagnosis to reflect the name in the latest version USCDI v4.
4. We recommend that ONC modify the USCDI+ Quality Data Element from Location to Encounter Location to reflect the name in the latest version USCDI v4.
5. We recommend that ONC modify the USCDI+ Quality Data Element from Disposition to Encounter Disposition to reflect the name in the latest version USCDI v4.
6. We recommend that ONC modify the USCDI+ Quality Data Element from Identifier to Encounter Identifier to reflect the name in the latest version USCDI v4.
7. We recommend that ONC modify the USCDI+ Quality Data Element from Status to Encounter Status to reflect the name in the latest version USCDI v4.

 

Explanation of Benefits

We recommend that USCDI+ Quality include the Explanation of Benefits (EOB) Data Class and Data Elements from the USCDI Comment Level as many are required by the CARIN IG for Blue Button. We believe these EOBs demonstrate extensive existing use in systems and exchange between systems and as part of multiple use cases that show significant value to current and potential users.

 

Additional Data Elements

There are important gaps in content for future measures, such as the ability to track longitudinal improvement.  This likely reflects the limitations in existing measures; however, creating a process for incorporating greater specificity to data elements as new FHIR IGs for quality measurement are available will be important for rapid uptake.

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Level of Specificity

Some areas need greater specificity (e.g., Care experiences and outcomes).  Areas like the cancer elements from mCode appear to have more specificity.  

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Usefulness of Companion Guidance

The crosswalk between USCDI+QM and the CMS eCQMs is very helpful.

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Frequency of Updates

Given the national strategy to move to digital measures and to incorporate more measures based on patient-reported outcomes, ONC should consider ways to align the process for updating USCDI and USCDI+QM in ways as new FHIR-specified measures and implementation guides become available. This will supports faster vendor adoption of data capabilities for quality activities.

In 2023, ONC accepted feedback on USCDI until April 17, 2023 and stated that they expect to release a final USCDI v4 in July 2023. The CARIN Alliance recommends that the USCDI+ comment period follow a similar pattern to USCDI and be consistent each year. In addition, CARIN recommends that the comment period not overlap with the USCDI comment period and could instead follow the USCDI comment period as it did this year (June, 30 2023).

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In the attachments, we included a CPCDS - USCDI - USCDI+ Class and Data Element crosswalk that maps the various Data Classes and Data Elements between CPCDS - USCDI - USCDI+. Of note, it does not map to all the USCDI and USCDI+ Classes and Data Elements, only to those related to CPCDS. We hope this is helpful and are happy to provide a walk through of the crosswalk, if helpful.

Thank you again for providing the opportunity to comment on these data elements. We appreciate your consideration and if you have any questions or additional follow-up, please contact a member of our administrative team at mark.roberts@leavittpartners.com or ryan.howells@leavittpartners.com.  

Thank you for considering our recommendations.

 

Sincerely,

The CARIN Alliance

 

 

 

[1] https://www.cms.gov/Regulations-and-Guidance/Guidance/Interoperability/index

[2] https://bluebutton.cms.gov/developers/