Analysis: ONC Interoperability and Information Blocking Final Regulation

Provisions Related to Quality Program Reporting for Certified EHR Technology: A HIMSS Analysis.

What Stakeholders Should Know in Order to Be Compliant with the Final Regulation

ONC’s Final Regulation is intended to allow the flow of critical clinical information from system to system and provider to provider in part to facilitate better decision support and support new alternative payment models for care. To facilitate the flow of critical information, the following changes have been made in the requirements for electronic health records (EHRs) for providers to be compliant with Certified EHR Technology (CEHRT) for the Promoting Interoperability Program.

CEHRT must support the Centers for Medicare & Medicaid Services (CMS) Quality Reporting Document Architecture (QRDA) I and III Implementation Guides.

• QRDA I facilitates the transfer of patient level data and is required for inpatient quality reporting.
• QRDA III facilitates the transfer of aggregate data and is utilized for outpatient quality reporting.

CEHRT can continue to support the Health Level Seven International (HL7) QRDA I and III Implementation Guides. However, CEHRT will not be tested for the HL7 QRDA I and III Standards.

Health IT modules which only support inpatient quality reporting only need to be tested for QRDA I to gain CEHRT certification.

Health IT modules which only support outpatient quality reporting need to be tested for QRDA III to gain CEHRT certification.

Health IT modules which support both inpatient and outpatient quality reporting will need to be tested to both QRDA I and III Standards to gain CEHRT certification.

Outstanding Questions

For a future state where clinical data elements will be utilized to populate quality measures via Fast Healthcare Interoperability Resources (FHIR®)-based application programming interfaces (APIs) for CMS quality reporting, how will CMS ensure that the raw data accurately reflects the quality of care being delivered? Currently, health systems must do data validation on all quality measures before submitting data to CMS.

Summary and Analysis

Background and Relevant Changes Leading Up To the Final Regulation

Interoperability is critical to driving high quality care delivery. Clinical data from other care encounters is necessary to populate decision support and effectively risk adjust patients and inform clinician decision-making at the point of care. The ONC Final Regulation is intended to allow the flow of critical clinical information from system to system and provider to provider in part to facilitate better decision support and support new alternative payment models for care.

For alternative payment models to be effective, electronic clinical quality measures (eCQMs) must provide accurate assessments of the quality of care being delivered to determine payment.

In its Final Regulation, ONC removed the requirement for CEHRT to support the HL7 QRDA I and III Implementation Guides. In recent years, CMS has developed QRDA Implementation Guides, which utilize the HL7 Implementation Guides, with additional functionality required for CMS data collection means.

CMS found that QRDA I and III are used primarily, but not exclusively, to report quality measures for CMS quality programs, most notably the Inpatient Quality Reporting (IQR) program for hospitals, and the Merit-Based Incentive Payment System (MIPS) for ambulatory care. As result, CEHRT will only need to support the CMS QRDA Implementation Guide.

The rulemaking does not preclude developers from continuing to support the HL7 standard, especially where such a standard may support reporting or health information exchange for other quality or public health purposes. CEHRT just will not be tested or certified to the HL7 standard and will not be required to support both QRDA I and III.

To become CEHRT, health IT modules must meet the criteria detailed in “CQM – capture and export” criterion, Health IT modules which only support inpatient quality reporting only need to be tested for QRDA to gain certification. Health IT modules which only support outpatient quality reporting need to be tested for QRDA III. Health IT modules which support both inpatient and outpatient quality reporting will need to be tested to both QRDA I and III standards.

In February, CMS Administrator Seema Verma detailed the future state of electronic clinical quality measurement as part of the new CMS Quality Strategy. As part of this strategy, CMS has stated a goal of clinicians and hospitals leveraging the FHIR-based standards through APIs to submit quality data.

Quality measurement-related clinical data elements will flow to a centralized submission system to perform measure calculations and exchange data and results with several applicable quality programs. CMS has stated “data element reporting” enabled by FHIR would facilitate a real time feedback loop, allowing hospitals and clinicians to be more nimble in addressing care gaps and poor outcomes. CMS has also stated that the seamless transmission of quality measures directly from EHRs will reduce burden.

In its Final Regulation, ONC assessed that quality reporting is not yet ready to transition to FHIR. ONC stated that “more testing and validation of FHIR is needed before requiring a new API-based reporting functionality as a part of the Program.”

Additional Commentary and Analysis

While HIMSS members agreed with CMS assessment that QRDA I and III was being used almost exclusively for reporting to CMS quality programs, members expressed concern with the precedent being set by this action. CMS drove the utilization of a standard, which meets their data collection needs, not necessarily the needs of industry.

The National Technology Transfer and Advancement Act of 1996 dictates that federal agencies are required to use technical standards that are developed by voluntary consensus standards bodies rather than a proprietary standard specific to a federal agency, except when the adoption meets specific criteria.

While CMS consulted with HL7, the CMS QRDA I and III implementation is a proprietary standard specific to a CMS quality reporting program. Public comments were delivered stating that CMS implementation guides should have been vetted, balloted, and approved for inclusion within the HL7 standard.

In addition, HIMSS members have expressed significant concerns regarding direct extraction of quality data for measurement by CMS. Many members state that EHR data must be reviewed and validated currently by hospitals and clinicians before submission to CMS in order to ensure the data accurately reflects the numerators, denominators, clinical exemption criteria, and quality of care being delivered.

Please contact policy@himss.org to find out more ways to become involved with HIMSS’s efforts on this issue.