Clinical quality measures (CQMs) — record and export

Clarifications:

• Health IT needs to be able to record all data necessary to successfully calculate selected clinical quality measures (CQMs).
• Health IT developers are permitted to test and certify to the newest versions of the HL7® CDA® R2 Implementation Guide: Quality Reporting Document Architecture - Category I (QRDA I) and Category III (QRDA III) IGs, regardless of the versions approved by the National Coordinator via the Standards Version Advancement Process (SVAP).
• The specific version, number, and type of CQMs presented for certification are determined at the developer’s discretion. ONC recommends developers consult any CMS or other programs’ requirements around the specific version, number, or type of CQMs required for providers in determining the CQMs presented for certification.
• Certain CMS programs require or provide the option for electronic CQM (eCQM) reporting. These programs include the Promoting Interoperability Programs, 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 a specific version of the Quality Reporting Document Architecture (QRDA) Category I standard. Each year’s QRDA Category I standard is referenced in the corresponding CMS QRDA Implementation Guide (IG) associated with that program year and CMS annual measure update. The CMS QRDA IG also contains 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. Thus, health IT developers are permitted to be tested and certified to the applicable CMS annual measure update and use the corresponding version of QRDA Category I standard referenced in the CMS QRDA IG. ONC will evaluate the need for future rulemaking to align the version of QRDA Category I standard required for this certification criterion with the version of QRDA Category I standard in the CMS annual measure update.
• After technology is certified to specific CQMs for this § 170.315(c)(1) criterion, technology is not required to recertify to the annual measure specification updates CMS issues to maintain certification unless that product is relabeled. Said another way, other programs, such as the Promoting Interoperability Programs, may require developers to upgrade their technology to the newest CQM specifications, but the technology is not required to be retested or recertified for eCQMs already certified unless explicitly specified in other program requirements. It is expected that all systems will test all measure 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 for products using eCQMs.
• 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.

Technical outcome – The health IT must be able to record all data necessary to calculate CQMs presented for certification.

Clarifications:

• Providers may employ many methods to capture the information required by CQMs. Information transferred from other systems can meet the requirement for “capture.” [see also 77 FR 54230] ONC recommends developers include functionality that allows users to view any information transferred from other systems.
• ONC-Authorized Testing Labs (ONC-ATLs) are permitted to provide flexibility regarding data elements for manual entry where the measure allows multiple ways to express the same data criteria or alternate data criteria where appropriate.
• Data required for CQM exclusion or exceptions must be codified entries and may include specific terms defined by each CQM selected. Free text is permitted to be captured in addition to the minimum requirement to capture data as a codified entry.
• Specific reasons why an action was performed or not performed to determine whether the patient meets an exclusion or exception should be recorded as part of the generated QRDA Category I file.

Technical outcome – A user can export a data file formatted in accordance with HL7® QRDA Category I Release 3 or the corresponding version of the QRDA standard for the CMS annual measure update being certified for one or multiple patients that includes all of the data captured in (c)(1)(i) of this criterion.

Clarifications:

• A user of this health IT must be able to create these reports at any time selected without additional assistance from health IT developers. This will allow a provider or health system to view and verify their CQM results for quality improvement on a near real-time basis. It also gives providers the ability to export their results to multiple programs, such as those run by CMS, states, and private payers, and/or reporting solutions, such as registries or other types of data intermediaries. While a user of this health IT must be able to create these reports at any time selected without additional assistance from health IT developers, health IT developers can claim technology downtime for software upgrades (to accommodate upgrades for the latest QRDA specification, for example). Health IT developers experiencing technology downtime for software upgrades should communicate their reason for technology downtime and when their technology will again be operational. [see also 77 FR 54230 and 80 FR 62650]
  • Testing and Certification. Successful testing and certification does not require the evaluation of the time required to process a CQM data file. To illustrate, a delay between when a user initiates an export and receives the resulting data file would not, by itself, preclude successful testing of the technology or the issuance of a certification on the basis of those successful test results.
  • Surveillance. While the CQM export capability does not require that data be received instantaneously, a non-conformity would exist if surveillance revealed that processing or other delays were likely to substantially interfere with the ability of a provider or health system to view and verify their CQM results for quality improvement on a near real-time basis. [80 FR 62650] Similarly, a non-conformity would exist if delays were causing or contributing to users being presented with data files that no longer contained current, accurate, or valid data. To avoid these implementation issues and ensure that capabilities support all required outcomes, health IT developers should seek to minimize processing times and other delays to the greatest extent possible. ONC notes also that any delays must be disclosed in accordance with § 170.523(k)(1).
• Providers and health systems should determine the protocols around when and how providers export CQM data. As noted above, for testing, the health IT would need to demonstrate a user can export data formatted to QRDA Category I for one or more patients without needing additional developer support. [see also 80 FR 62650]