Public Health and Clinical Data Exchange
Clinical Data Registry Reporting
Definition of Terms
The MIPS eligible clinician is in the process of moving towards sending "production data" to a public health agency or clinical data registry, or is sending production data to a public health agency (PHA) or clinical data registry (CDR).
Active engagement may be demonstrated in one of the following ways:
- Option 1 – Pre-Production and Validation: The MIPS eligible clinician must first register to submit data with the PHA or, where applicable, the clinical data registry (CDR) to which the information is being submitted. Registration must be completed within 60 days after the start of the performance period, while awaiting an invitation from the PHA or CDR to begin testing and validation. MIPS eligible clinicians that have registered in previous years do not need to submit an additional registration for subsequent performance periods. Upon completion of the initial registration, the MIPS eligible clinician must begin the process of testing and validation of the electronic submission of data. The MIPS eligible clinician must respond to requests from the PHA or, where applicable, the CDR within 30 days; failure to respond twice within a performance period would result in the MIPS eligible clinician not meeting the measure.
- Option 2 – Validated Data Production: The MIPS eligible clinician has completed testing and validation of the electronic submission and is electronically submitting production data to the PHA or CDR.
Refers to data generated through clinical processes involving patient care, and it is used to distinguish between data and “test data” which may be submitted for the purposes of enrolling in and testing electronic data transfers.
The MIPS eligible clinician must attest YES to being in active engagement to submit data to a clinical data registry.
- Required for Promoting Interoperability Performance Category Score: No
- Measure Score: N/A
- Eligible for Bonus Score: Yes, 5 points
Note:The following measures are included in the Public Health and Clinical Data Exchange objective: Immunization Registry Reporting (required), Electronic Case Reporting (required), Public Health Registry Reporting (optional), Clinical Data Registry Reporting (optional), and Syndromic Surveillance Reporting (optional).
In order to earn a score greater than zero for the Promoting Interoperability performance category, MIPS eligible clinicians must:
- Complete the Security Risk Analysis measure
- Review the High Priority Practices SAFER Guide1
- Complete the ONC Direct Review attestation
- Attest to the Actions to limit or restrict compatibility or interoperability of CEHRT statement
- Submit their complete numerator and denominator or Yes/No data for all required measures
- Submit their CMS certification identification number
- Submit their level of active engagement for the Public Health and Clinical Data Exchange measures
- Failure to report at least a “1” in all required measures with a numerator or reporting a “No” for a Yes/No response measure (except for the SAFER Guides measure2 ) will result in a total score of 0 points for the Promoting Interoperability performance category.
- In 2023, MIPS eligible clinicians must use technology certified to the 2015 Edition of health IT certification criteria and updated to the 2015 Edition Cures Update to meet the CEHRT definition. (85 FR 84472)
- To learn more about the 2015 Edition Cures Update and the changes to 2015 Edition certification criteria finalized in the 21st Century Cures Act final rule (85 FR 25642), we encourage MIPS eligible clinicians to visit https://www.healthit.gov/curesrule/final-rulepolicy/2015-edition-cures-update.
- To check whether a health IT product has been certified to criteria updated for the 2015 Edition Cures Update, visit the Certified Health IT Product List (CHPL) at https://chpl.healthit.gov/.
- Certified functionality must be used as needed for a measure action to count in the numerator during a performance period. However, in some situations the product may be deployed during the performance period, but pending certification. In such cases, the product must be certified by the last day of the performance period.
- The measures under the Public Health and Clinical Data Exchange objective are reported using “yes or no” responses. The MIPS eligible clinician will receive the full 25 points for reporting two “yes” responses for the two required measures, or for submitting a “yes” for one measure and claiming an exclusion for another. If there are no “yes” responses and two exclusions are claimed, the 25 points will be redistributed to the Provide Patients Electronic Access to Their Health Information measure.
- Reporting on more than one of the three optional measures for this objective will not result in more than 5 bonus points.
- The definition of jurisdiction is general, and the scope may be local, state, regional or at the national level. The definition will be dependent on the type of registry to which the clinician is reporting. A registry that is ‘‘borderless’’ would be considered a registry at the national level and would be included for purposes of this measure.
- If the CDR does not use a specified standard, it must use another standard specified in 170.205 to meet the measure. For example, the transmission could be in the form of a Consolidated Clinical Document Architecture (C-CDA) per 170.205(a)(4), or Quality Reporting Document Architecture (QRDA) per 170.205(h)(2).
- Beginning with the performance period in CY 2024, MIPS eligible clinicians may spend only one performance period at the Pre-production and Validation level of active engagement per measure, and must progress to the Validated Data Production level in the next performance period for which they report a particular measure.
- MIPS eligible clinicians who have previously registered, tested, or begun ongoing submission of data to a registry do not need to “restart” the process.
- MIPS eligible clinicians may claim the exclusions if they are reporting as a group.
- When MIPS eligible clinicians choose to report as a group, data should be aggregated for all MIPS eligible clinicians under one Taxpayer Identification Number (TIN). This includes those MIPS eligible clinicians who may qualify for reweighting through an approved Promoting Interoperability hardship exception, hospital or ASC-based status, or in a specialty which is not required to report data to the Promoting Interoperability performance category.
- For further discussion, please see the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) final rule: 81 FR 77229.
- For additional discussion, please see the 2022 and 2023 Physician Fee Schedule final rules.
- • No 2015 Edition health IT certification criteria are required at this time.
1 The SAFER, or Safety Assurance Factors for EHR Resilience, Guides measure was added in the CY 2022 Physician Fee Schedule Final Rule.
2 In 2023, eligible clinicians will be required to submit one “yes/no” attestation statement for completing an annual self-assessment of the High Priority Practices SAFER Guide, but the “yes” or “no” attestation response will fulfill the measures.