By David Bucciferro, Chair, EHR Association

In previous installments of this five-part blog series, we examined the EHR Association’s overarching concerns with ONC’s Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Proposed Rule (HTI-1), as well as concerns with the transition to USCDI v3, proposed requirements related to Decision Support Interventions (DSI) and Predictive Models, and Patient Requested Restrictions. In this installment, we focus on our concerns with the HTI-1’s new Insights Condition and Maintenance of Certification Requirements provision.

According to ONC, Insights Condition fulfills a requirement in the 21^st Century Cures Act for transparent reporting by creating a program to measure the performance of certified health IT (CEHRT) under a Condition and Maintenance of Certification. The goals of the EHR reporting program are to 1) address information gaps in the health IT marketplace and 2) provide insights on the use of specific certified health IT functionalities. 

This would be accomplished through semi-annual reporting by CEHRT developers on the following measures for any applicable certified health IT module that has/has had an active certification during the prior six months.

More Time, Incentivized Cooperation Needed

While we support the goals of the Insights Condition program, the proposed timeframe is entirely too short to properly prepare, recruit clients for, execute, and report on the required Insights. In fact, the work entailed is far greater than ONC has suggested in its impact analysis. 

We had made this clear in feedback to ONC’s contractor for this program, in which we also explained why many of the initial ideas were untenable or particularly burdensome. While we appreciate that they have tried to be more pragmatic in the proposed rule, challenges remain. For starters, the proposed Insights measures harken back to the early days of the meaningful use program but without incentives for providers to cooperate. This puts EHR vendors in the middle of data aggregation from multiple sources – and distracts from other analytics initiatives that software developers are expected to support, like CMS’ digital quality measures project. 

Because the work to prepare for the measurement and to convince clients to work with developers on the project will be consequential, we urge ONC to delay the start of the first measurement period until at least CY 2025. We would also like to see it restructured for annual reporting, preferably mid-year to avoid conflict with significant year-end deadlines, development and deployment obligations, and April/October attestations we’re already required to submit. 

Further, given the lack of enthusiasm from healthcare providers when it comes to supporting real-world testing obligations by vendors, it is highly unlikely they will embrace the need to cooperate on Insights Condition reporting, which has a far broader scope. As such, we urge CMS to include a mandate or condition that incentivizes provider organizations using EHRs to work with their health IT partners to address this issue. 

Multiple Concerns

In other blogs in this series, we share our concerns with three additional provisions of HTI-1: the transition to USCDI v3, the proposed requirements related to Decision Support Interventions (DSI) and Predictive Models, and Patient Requested Restrictions. 

In doing so, our hope is that ONC gives full consideration to our concerns – which we share with other impacted stakeholders – as it moves forward with finalizing the rule to ensure its end goals can be achieved without unrealistic deadlines and without placing an undue burden on healthcare providers and health IT developers.