§170.315(c)(3) Clinical quality measures (CQMs) — report

Technical outcome – Enable a user to electronically create a data file for transmission of CQM data in accordance with the CMS Quality Reporting Document Architecture (QRDA) Category I Implementation Guide (IG) for inpatient measures as adopted in § 170.205(h)(3) and CMS QRDA Category III IG for ambulatory measures as adopted in § 170.205(k)(3).

Clarifications:

• The specific version, number, and type of clinical quality measures (CQMs) presented for certification are determined at the developer’s discretion. We recommend developers consult any Centers for Medicare and Medicaid Services (CMS) or other programs’ requirements around the specific version, number, or type of CQMs required for providers in determining the CQMs presented for certification.
• Health IT developers are permitted to test and certify to the newest CMS QRDA Category I and Category III IGs, regardless of the versions approved by the National Coordinator via the Standards Version Advancement Process (SVAP).
• Certain CMS programs require or provide the option for electronic CQM (eCQM) reporting. These programs include the Promoting Interoperability Program, the Physician Quality Reporting System, the Hospital Inpatient Quality Reporting Program, the Comprehensive Primary Care (CPC) initiative, CPC Plus, and the Value-Based Payment Modifier Program. Each year, CMS issues annual updates to eCQMs (herein referred to as the “CMS annual measure update(s)”) which are published on the Electronic Clinical Quality Improvement (eCQI) Resource Center. The CMS annual measure updates rely upon specific versions of the HL7® Quality Reporting Document Architecture (QRDA) Category I and Category III standards. Each year’s HL7® QRDA Category I and Category III standards are referenced in the corresponding CMS QRDA Implementation Guides (IGs) associated with that program year and CMS annual measure update. The CMS QRDA Category I and Category III IGs also contain additional programmatic form and manner requirements necessary for reporting to CMS programs, which make it necessary for the corresponding testing tools to keep pace with these measure updates and CMS reporting requirements.
• Compliance with this certification criterion is dependent on the update to the CMS QRDA Category I and Category III IGs. It is ONC's expectation that health IT developers will update Health IT Modules to align with the 2020 CMS QRDA Category I and Category III IGs in a timely fashion that allows users to report eCQMs to CMS in early 2021. Health IT developers should continue to update Health IT Modules to align with the CMS annual update to the CMS QRDA Category I and Category III IGs for continued compliance with this certification criterion.
• For details on the latest CMS QRDA Category I and Category III IGs, ONC refers readers to the eCQI Resource Center website.
• After technology is certified to specific CQMs for this 2015 Edition certification criterion at § 170.315(c)(3), technology is not required to recertify to the annual measure specification updates CMS issues to maintain 2015 Edition certification unless that product is relabeled. Said another way, other programs, such as the Promoting Interoperability Program, may require developers upgrade their technology to the newest CQM specifications, but the technology is not required to be retested or recertified unless explicitly specified in other program requirements. [see also the ONC Health IT Certification Program Overview] It is expected that all systems will test all measures and standards updates as a best practice. The testing tools are available for each CMS annual measure update and when there are late standards errata or CMS requirement changes to facilitate additional testing.
• While health IT developers are not required to re-certify to updated versions of CQMs, they must test and certify to newly added CQMs. 
• For the purposes of automated testing to meet certification requirements, only errors (but not warnings) generated during testing would constitute a failure to meet certification requirements.
• In order to prevent unintended burden by tailoring the requirements to the type of measures being tested ONC has provided the following clarifications:  For the updated certification criterion “CQMs—report” in § 170.315(c)(3) a Health IT Module testing only inpatient measures would test only with the CMS QRDA Category I IG and a Health IT Module testing only ambulatory measures would test only with the CMS QRDA Category III IG. A Health IT Module supporting both inpatient and ambulatory measures would be required to test to both the CMS QRDA Category I and Category III IGs.
• The following links are references to CMS CQM reporting resources:
  • CMS and ONC eCQI Resource Center
  • CMS Quality Measure Basics
  • CMS Promoting Interoperability Program Resource Page (contains program requirements, reporting requirements, and other resources for each program year).
• Compliance date updated to December 31, 2022, per IFR.
• Health IT developers can choose to use the flexibility of the SVAP to use more advanced version(s) of standards than the version(s) incorporated by reference in the regulation for this certification criterion.  To comply with the Maintenance of Certification requirement in §170.405(b), a developer that chooses to pursue such updates must include in their Real World Testing plan each Certified Health IT Module updated to newer version(s) of any standard(s) prior to August 31 of the year in which their updates were made and test each Module the following calendar year for conformance to all applicable criteria within its scope, including the newer version(s) of any standard(s).
• Health IT developers updating their already Certified Health IT Modules who choose to leverage the SVAP flexibility will be required to provide advance notice to all affected customers and its ONC-ACB. To be open and transparent to the public, health IT developers must also provide its ONC-ACB with a publicly accessible hyperlink to the SVAP Notice to be published with the Module on the ONC Certified Health IT Product List (CHPL).