§170.315(c)(2) Clinical quality measures (CQMs) — import and calculate

Clarifications:

• The specific version, number, and type of clinical quality measures (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.
• 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).
• 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 tool 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. Note that for this criterion at § 170.315(c)(2), the testing tools are only capable of validating the correct calculation of CQMs for reports submitted in the corresponding QRDA Category III format. 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 2015 Edition certification criterion at § 170.315(c)(2), 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 Programs, 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 Health IT Certification Program Overview] 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.
• Systems that present for certification to § 170.315(c)(1), (c)(2), (c)(3) must explicitly demonstrate this criterion at § 170.315(c)(2). Those systems previously considered “self-contained” according to the 2014 Edition policy will no longer be deemed to meet certification for § 170.315(c)(2). [see also 80 FR 62650]
• 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 – A user can import 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 in order to perform calculations on the CQMs presented for certification.

Clarifications:

• A user of this health IT must be able to import a data file at any time selected without additional assistance from health IT developers. ONC is not prescribing how data is imported into a system (e.g., mapped to backend database or viewable to a provider as part of the patient record) and leaves the determination at the discretion of the developer. [see also 80 FR 62650]
  • Testing and Certification. Successful testing and certification do 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. [see also 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).
• This provision will streamline testing and certification by importing QRDA Category I files avoiding the need for systems to manually enter test patient data. It will also promote quality improvement and data sharing between systems by providing the systems the ability to import CQM data from other systems in a standardized format. [see also 80 FR 62650]
• Providers and health systems should determine the protocols around when and how providers import CQM data. For testing, the health IT would need to demonstrate a user can import data formatted to QRDA Category I for one or more patients without needing additional developer support. [see also 80 FR 62651]
• ONC would expect that health IT must be able to de-duplicate patient records, but do not prescribe how systems would demonstrate de-duplication. Developers have the discretion to determine the most suitable method for de-duplication. [see also 80 FR 62651] De-duplication testing will require systems to identify two files with the same or similar patient identifiers but different QRDA document identifiers and adjudicate information that is identical and combine information that is not.
• Testing will more robustly test the pathways by which a patient is included in the numerator and/or denominator, including exclusions and exceptions, of a measure. [see also 80 FR 62651]

Technical outcome – The health IT must be able to calculate each CQM presented for certification.

Clarifications:

• The testing tools are only capable of validating the correct calculation of CQMs for reports submitted in the QRDA Category III format.