EHRA raises concern over regulatory deadlines

During a virtual media briefing this week, the HIMSS Electronic Health Record Association outlined some of the comments it plans to send the Office of the National Coordinator for Health IT about its draft Health Data, Technology and Interoperability: Certification Program Updates, Algorithm Transparency and Information Sharing proposed rule, or HTI-1.

While some of the rule’s details are still being parsed, EHRA said it has reservations about the ability of its member IT companies to balance new regulatory compliance with other HHS requirements – and has questions about a lack of provider incentives, information blocking rule challenges and more.

“The EHR Association has several considerable concerns about the ONC HTI-1 proposed rule, particularly regarding the suggested implementation timeframes, the burden compliance would place on both provider organizations and health IT developers and misalignment between ONC and [Centers for Medicare and Medicaid Services] requirements,” the organization said in a statement Thursday.

Need for “sufficient time”
While recognizing that ONC is under pressure to implement requirements of the 21st Century Cures Act, EHRA called for some leeway.

In order to do “high-quality work and ensure that the work we’re doing is going to be safe to the users of our systems,” time frames must be adjusted, said David Bucciferro, special advisor at Foothold Technology-Radicle Health and chair of the EHR Association.

It often takes at least 18-24 months to develop, test and safely deploy new versions of health IT software, he noted.

“It really seems like the time frames that were drafted last fall were not adjusted, even though we’re six to eight months further along,” he added “It really doesn’t give us sufficient time to complete the sizable work that the development teams have to do to make this a reality.”

Bucciferro said eight of EHRA’s workgroups are putting together an analysis that will highlight the effect those time frames will have on both software developers and providers.

“We will encourage ONC to take a closer look at those aspects of the proposed rule that fail to sufficiently consider the burden compliance would place on both provider organizations and health IT developers if adjustments aren’t made before finalizing,” said EHRA in a statement.

Data aggregation challenges
HTI-1’s insights requirement for maintenance of certification requires software vendors to recruit clients to participate, said Altera Digital Health VP of Government Affairs & Public Policy Leigh Burchell, an EHR Association representative.

“Their impact analysis is not accurate in the rule, and we’re going to be doing our best to help them understand why that’s the case.”

Burchell compared the measures the agency suggested to “the days of meaningful use, where we have all of these measures for people to check off, but in this case, there is no incentive for providers to participate to be supportive of the things we have to get done.”

That puts vendors in the middle of data aggregation, forcing them to get a lot of information from multiple data sources where the agencies “in theory, could use other regulatory levers available either within ONC or [Health and Human Services] to gather that information directly if they wanted to,” said Burchell.

For the EHRA members that need to gather and submit this insights data, “are we going to be able to have enough clients who are willing to do it?”

There are also other analytics priorities, like digital quality measures from CMS, that will have an impact on provider workflows, she noted.

The Medicare and Medicaid Electronic Health Record Incentive Programs and ONC’s insights program have some duplication, like certification and real-world testing.

Even with real-world testing, clients are not overly enthusiastic about supporting what they need to do there, Burchell said.

EHRA will be asking ONC to delay the start of the first measurement period to January 2025 and to extend the reporting period to one year, with the first report to be submitted mid-year 2026, Burchell said, adding that adjusting the proposed reporting time frame will avoid conflict with other regulatory deadlines.

“We continue to encourage ONC and CMS to work together to resolve disconnects between the requirements they are imposing on various stakeholders in healthcare,” according to a statement from EHRA.

“For example, there are frequent misalignments between when ONC expects new certified software versions to be deployed and when CMS requires provider organizations to be using those new versions, with insufficient time allowed by CMS for implementation and testing of new versions. There are also included within HTI-1 proposals that require healthcare providers to collaborate with us in order for us to be able to fully comply, but CMS has not included any requirement that they do so in their own regulations.”

All-or-nothing USCDI requirements
The timeline is aggressive, and the United States Core Data for Interoperability scope is expanding all the time. But the time frame from the final rule to the suggested implementation date of December 2024 does not leave enough time – maybe 14 or 15 months, Burchell explained.

Large institutions want nine months to a year from getting the new version of software to do their own testing and training, she said.

EHRA will be asking for a two year deadline following the release of the rule, and an end to the “all-or-nothing requirement.”

Not every hospital or care environment needs everything that is included in USCDI, said Burchell. And for those who don’t need everything in USCDI v3, and just what is clinically relevant, “they should be allowed to achieve certification by adding only the aspects they need to meet their user needs” in order to reduce the software developer and provider burdens, said Burchell.

Wayne Singer, vice president of regulatory services for the Darena Solutions, which offers the FHIR-enabled MeldRx Ecosystem, previously told Healthcare IT News that vendors are concerned about the practicalities of the USCDI minimum data sets expected for interoperability.

“We are concerned it is hard for providers to embrace the new data elements of the constantly evolving USCDI standards, and adding FHIR further complicates it,” he said.

“In reality, a significant percentage of clinical documentation is still captured in unstructured data, and far too many patient records are exchanged by fax. Committing time, money and resources to enhancements that providers don’t find valuable for their workflows becomes extremely challenging for health IT developers.”

Overly burdensome CDS rules
HTI-1’s suggestions around the predictive rules are unclear and confusing, added Dr. Michael Blackman, chief medical officer at Greenway Health and an EHR Association representative.

“The current suggestion is overly broad. We recommended there be some narrowing of that definition so that it’s quite clear what is predictive, what’s not, and where you would need that additional source attribution,” he said.

“There is an assumption that seems to be that EHRs create the decision support. That is often not the case,” he added, noting that many clients use third parties or create their own.

The burden of reporting would result in a lot of duplicative work when sourcing for the same vendors, and the timeline to report by December 2024 is also too tight.

A better scenario, Blackman suggested, is having the third-party vendors “add the provenance information and the other data requested around the source of the data, as opposed to each EHR individual redoing it, where frankly we often don’t even know the answer.”

While requesting feedback on decision support is a valid request, he pointed out that most of it comes in passively, and there is often no mechanism forcing consideration.

Adding additional alerts could impose “additional cognitive load” and burden that is not helpful “in the course of seeing patients,” he said.

EHRA will be suggesting limiting that feedback requirement to interruptive decision support. The organization will also be asking to maintain CDS terminology, as opposed to the proposed decision support intervention, or DSI.

The change is “really an acknowledgment that decision support is being used across a range of use cases that are both clinical and nonclinical in nature, and the electronic health record is increasingly central to these use cases,” according to ONC’s overview at HIMSS23. Healthcare IT News