EHRA takes issue with HTI-1’s burdensome, competing requirements

During a virtual media briefing this week, the HIMSS Electronic Health Records Association outlined some comments it provided to the Office of the National Coordinator for Health IT regarding its draft Health Data, Technology, and Interoperability: Certification Program Update, Algorithm Transparency, and Information I am planning to send. Sharing Proposed Rules, or HTI-1.

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

“The EHR Association has a number of significant concerns about the ONC HTI-1 proposed rule, particularly regarding the suggested implementation timeline, the burden compliance will place on both provider organizations and health IT developers, and the burden on ONC and (Medicare and Medicaid services) There will be misalignment between the Centre’s) requirements,” the organization said in a statement on Thursday.

Need for “Sufficient Time”

Recognizing that the ONC is under pressure to implement the requirements of the 21st Century Cures Act, the EHRA called for some relaxations.

“In order to do high quality work and to make sure that the work that we’re doing is going to be safe for the users of our systems,” the time frame has to be adjusted, Davide Bucifero said. Foothold Technology-Special Advisor in Radical Health and President of EHR Association.

New versions of health IT software often take at least 18-24 months to develop, test and safely deploy, he said.

“It really looks like the time frame that was drafted last fall was not adjusted, even though we are six to eight months ahead,” he said. Doesn’t give enough time that the development teams would have to do to make this a reality.”

Bucciferro said eight of EHRA’s workgroups are conducting an analysis that will highlight the impact the timeline will have on both software developers and providers.

In a statement, the EHRA said, “We would encourage the ONC to take a closer look at those aspects of the proposed rule that fail to adequately consider the burden compliance will have on both provider organizations and health IT developers, if ultimately Adjustments are not made before shaping.” ,

Data Aggregation Challenges

Maintenance of certification requires software vendors to enroll customers to participate in HTI-1’s insight requirement, said Altera Digital Health VP of Government Affairs and Public Policy Leigh Burchell, an EHR association representative.

“Their impact analysis is not accurate in the rule, and we are doing our best to help them understand why that is.”

Burchell compared the measures suggested by the agency to “the days of meaningful use, where we have all these measures to test people, but in this case, there’s no incentive for providers to support things that We have to get it done.”

This puts vendors in the middle of data aggregation, forcing them to get lots of information from multiple data sources, where agencies “could, in theory, be able to collect that information directly from the ONC or[Health]and other regulatory levers available within the Human Services). If they wanted to,” Burchell said.

For EHRA members who need to collect and submit this insightful data, “Do we have enough customers willing to do it?”

He added that there are also other analytics priorities, such as digital quality measures from the CMS, that will have an impact on provider workflows.

The Medicare and Medicaid electronic health records incentive program and ONC’s Insights program have some duplication, such as certification and real-world testing.

Burchell said that even with real-world testing, customers haven’t been overly enthusiastic about supporting what needs to be done out there.

EHRA will ask the ONC to delay the start of the first measurement period to January 2025 and extend the reporting period by one year, with the first report to be submitted in mid-2026, Burchell said, adding that the proposed reporting deadline will be accommodated by other regulatory timing. Conflict with Seema has to be avoided.

According to a statement from the EHRA, “We continue to encourage ONC and CMS to work together to resolve the disconnect between the requirements being imposed on various stakeholders in healthcare.”

“For example, when ONC expects to deploy new certified software versions and when CMS requires provider organizations to use those new versions, there is insufficient time for CMS to implement and test the new versions. Misalignments are often accompanied. HTI-1 also includes proposals that require healthcare providers to cooperate with us to fully comply, but CMS has not included a requirement that they do so in their own rules. Are.

All-or-Nothing USCDI Requirements

The timeline is aggressive, and United States Core Data’s scope for interoperability is expanding all the time. But the deadline from the final rule to the suggested implementation date of December 2024 doesn’t leave enough time — perhaps 14 or 15 months, Burchell explained.

He added that large organizations take nine months to a year to do their testing and training on the new version of the software.

The EHRA will ask for a two-year time limit and an end to the “all-or-nothing requirement” after the rules are issued.

Not every hospital or care environment needs everything included in the USCDI, Burchell said. And for those who do not need everything in USCDI v3, and that is clinically relevant, “they should be allowed to seek certification by adding only those aspects that are necessary to meet their user’s needs.” are” so as to reduce to software developer and provider. Burden, Burchell said.

Wayne Singer, vice president of regulatory services for Darena Solutions, which provides the FHIR-enabled MeldRx ecosystem, previously reported Healthcare IT News Vendors are concerned about the practicality of the USCDI minimum data set required for interoperability.

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

“Indeed, a significant percentage of clinical documentation is still captured in unstructured data, and many patient records are exchanged by fax. Giving time, money, and resources to such enhancements What providers do not find valuable to their workflows becomes extremely challenging for health IT developers.

Overburdened CDS Rule

HTI-1’s suggestions around prediction rules are vague and confusing, said Dr. Michael Blackman, Chief Medical Officer at Greenway Health and An EHR association representative.

“The current suggestion is too broad. We recommended that definition be narrowed down a bit so that it is clear what is predictable, what is not, and where you would need that additional source attribute,” he said.

“There is a perception that it seems that EHRs create decision support. Often this is not the case,” he said, noting that many customers use third parties or build their own.

There will be a lot of duplication of work due to the reporting burden when sourcing for the same vendors, and the reporting deadline of December 2024 is also very tight.

A better scenario, Blackman suggested, is to have third-party vendors “aggregate the original information and other data requested around the source of the data, as opposed to having each EHR person do it again, where clearly than we often don’t even know the answer.”

While requesting feedback on decision support is a valid request, he pointed out that much of it comes passively, and often there is no mechanism in place to consider it.

Adding additional alerts may impose “additional cognitive load” and burden that is not helpful “when seeing patients”.

The EHRA would suggest limiting the need for that feedback to constrained decision support. The organization would also call for the CDS terminology to be retained, in contrast to the proposed decision support intervention, or DSI.

According to the ONC’s observation in HIMSS23, this change is “really an acknowledgment that decision support is being used in both clinical and non-clinical use cases, and that electronic health records are suitable for these use cases. increasingly central.”

Andrea Fox is a senior editor for Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.

During a virtual media briefing this week, the HIMSS Electronic Health Records Association outlined some comments it provided to the Office of the National Coordinator for Health IT regarding its draft Health Data, Technology, and Interoperability: Certification Program Update, Algorithm Transparency, and Information I am planning to send. Sharing Proposed Rules, or HTI-1.

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

“The EHR Association has a number of significant concerns about the ONC HTI-1 proposed rule, particularly regarding the suggested implementation timeline, the burden compliance will place on both provider organizations and health IT developers, and the burden on ONC and (Medicare and Medicaid services) There will be misalignment between the Centre’s) requirements,” the organization said in a statement on Thursday.

Need for “Sufficient Time”

Recognizing that the ONC is under pressure to implement the requirements of the 21st Century Cures Act, the EHRA called for some relaxations.

“In order to do high quality work and to make sure that the work that we’re doing is going to be safe for the users of our systems,” the time frame has to be adjusted, Davide Bucifero said. Foothold Technology-Special Advisor in Radical Health and President of EHR Association.

New versions of health IT software often take at least 18-24 months to develop, test and safely deploy, he said.

“It really looks like the time frame that was drafted last fall was not adjusted, even though we are six to eight months ahead,” he said. Doesn’t give enough time that the development teams would have to do to make this a reality.”

Bucciferro said eight of EHRA’s workgroups are conducting an analysis that will highlight the impact the timeline will have on both software developers and providers.

In a statement, the EHRA said, “We would encourage the ONC to take a closer look at those aspects of the proposed rule that fail to adequately consider the burden compliance will have on both provider organizations and health IT developers, if ultimately Adjustments are not made before shaping.” ,

Data Aggregation Challenges

Maintenance of certification requires software vendors to enroll customers to participate in HTI-1’s insight requirement, said Altera Digital Health VP of Government Affairs and Public Policy Leigh Burchell, an EHR association representative.

“Their impact analysis is not accurate in the rule, and we are doing our best to help them understand why that is.”

Burchell compared the measures suggested by the agency to “the days of meaningful use, where we have all these measures to test people, but in this case, there’s no incentive for providers to support things that We have to get it done.”

This puts vendors in the middle of data aggregation, forcing them to get lots of information from multiple data sources, where agencies “could, in theory, be able to collect that information directly from the ONC or[Health]and other regulatory levers available within the Human Services). If they wanted to,” Burchell said.

For EHRA members who need to collect and submit this insightful data, “Do we have enough customers willing to do it?”

He added that there are also other analytics priorities, such as digital quality measures from the CMS, that will have an impact on provider workflows.

The Medicare and Medicaid electronic health records incentive program and ONC’s Insights program have some duplication, such as certification and real-world testing.

Burchell said that even with real-world testing, customers haven’t been overly enthusiastic about supporting what needs to be done out there.

EHRA will ask the ONC to delay the start of the first measurement period to January 2025 and extend the reporting period by one year, with the first report to be submitted in mid-2026, Burchell said, adding that the proposed reporting deadline will be accommodated by other regulatory timing. Conflict with Seema has to be avoided.

According to a statement from the EHRA, “We continue to encourage ONC and CMS to work together to resolve the disconnect between the requirements being imposed on various stakeholders in healthcare.”

“For example, when ONC expects to deploy new certified software versions and when CMS requires provider organizations to use those new versions, there is insufficient time for CMS to implement and test the new versions. Misalignments are often accompanied. HTI-1 also includes proposals that require healthcare providers to cooperate with us to fully comply, but CMS has not included a requirement that they do so in their own rules. Are.

All-or-Nothing USCDI Requirements

The timeline is aggressive, and United States Core Data’s scope for interoperability is expanding all the time. But the deadline from the final rule to the suggested implementation date of December 2024 doesn’t leave enough time — perhaps 14 or 15 months, Burchell explained.

He added that large organizations take nine months to a year to do their testing and training on the new version of the software.

The EHRA will ask for a two-year time limit and an end to the “all-or-nothing requirement” after the rules are issued.

Not every hospital or care environment needs everything included in the USCDI, Burchell said. And for those who do not need everything in USCDI v3, and that is clinically relevant, “they should be allowed to seek certification by adding only those aspects that are necessary to meet their user’s needs.” are” so as to reduce to software developer and provider. Burden, Burchell said.

Wayne Singer, vice president of regulatory services for Darena Solutions, which provides the FHIR-enabled MeldRx ecosystem, previously reported Healthcare IT News Vendors are concerned about the practicality of the USCDI minimum data set required for interoperability.

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

“Indeed, a significant percentage of clinical documentation is still captured in unstructured data, and many patient records are exchanged by fax. Giving time, money, and resources to such enhancements What providers do not find valuable to their workflows becomes extremely challenging for health IT developers.

Overburdened CDS Rule

HTI-1’s suggestions around prediction rules are vague and confusing, said Dr. Michael Blackman, Chief Medical Officer at Greenway Health and An EHR association representative.

“The current suggestion is too broad. We recommended that definition be narrowed down a bit so that it is clear what is predictable, what is not, and where you would need that additional source attribute,” he said.

“There is a perception that it seems that EHRs create decision support. Often this is not the case,” he said, noting that many customers use third parties or build their own.

There will be a lot of duplication of work due to the reporting burden when sourcing for the same vendors, and the reporting deadline of December 2024 is also very tight.

A better scenario, Blackman suggested, is to have third-party vendors “aggregate the original information and other data requested around the source of the data, as opposed to having each EHR person do it again, where clearly than we often don’t even know the answer.”

While requesting feedback on decision support is a valid request, he pointed out that much of it comes passively, and often there is no mechanism in place to consider it.

Adding additional alerts may impose “additional cognitive load” and burden that is not helpful “when seeing patients”.

The EHRA would suggest limiting the need for that feedback to constrained decision support. The organization would also call for the CDS terminology to be retained, in contrast to the proposed decision support intervention, or DSI.

According to the ONC’s observation in HIMSS23, this change is “really an acknowledgment that decision support is being used in both clinical and non-clinical use cases, and that electronic health records are suitable for these use cases. increasingly central.”

Andrea Fox is a senior editor for Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.