Vendors air reservations about Stage 2

By Mike Miliard
10:58 AM

They're not the only ones.

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Specifically, EHRA is seeking to ensure that the committee's regulatory schedule for Stage 2 meaningful use allows sufficient time for its member companies to develop, implement and train users on new software releases. In its letter, the trade group said "the timeline for regulations and adoption" represented a "key risk" and urged a "focus in Stage 2 on building on Stage 1 capabilities and lessons learned" rather than charging ahead with new criteria and rapid-fire implementation timeframes.

"With the time required to develop software, perform adequate quality assurance, obtain ONCATCB certification and deploy the software in provider organizations (including internal testing, implementation of new features and enduser training), currently proposed timelines are simply not sufficient," EHRA officials wrote, "particularly as regulatory pressures on providers are exacerbated by 5010, ICD10 and other regulations that will go into effect in the next 24 months."

The group offered some suggestions, such as defining Stage 2, with an appropriate level of detailed requirements and technical specs, 18 months in advance, and even limiting Stage 2 to increased adoption of Stage 1 measures.

The letter also floated delaying Stage 2 and the expiration of the first certifications, suggesting launching Stage 2 in 2014 "for the earliest group of adopters while maintaining the current schedule of publishing specifications to allow for safe development and implementation."

"We expect that, given the lack of sufficient detail in this preliminary proposal and the experience of Stage 1 regulation, there will again not be sufficient detail to begin software development until the publication of proposed rules for Stage 2 meaningful use and 20132014 certification," the letter read.

"Final development would again have to be completed after the publication of the final rules, which we understand to be planned for the summer of 2012 clearly allowing insufficient time for eligible hospitals (EHs) to implement 20132014 certified software before Oct. 1, 2012 and eligible providers (EPs) by Jan. 1, 2013."

"We hope that the policy committee will consider our suggestions in this broader context as we work together to establish achievable objectives and measures that truly encourage adoption and use of interoperable EHRs," said Charlene Underwood, director of government and industry affairs at Siemens Medical Solutions and chairwoman of the EHRA workgroup.

Epic Executive Vice President Carl Dvorak, chairman of the EHRA, said the trade group, having shared its concerns, was initially "encouraged" by the ONC’s indication that it is "considering how to correct the timing issue.”

"We believe that a successful Stage 2 will focus on building on Stage 1 capabilities and lessons learned," he added, "and recommend that we all concentrate on those key initiatives that can be implemented broadly and deliver the most benefit for taxpayers' investment in health IT."

"We clearly recognize the critical importance of getting this right – not only for software developers but, more importantly, for the thousands of provider organizations that are working to achieve meaningful use," said the EHRA's vice chairman, Charlie Jarvis, vice president of healthcare services and government relations at NextGen.

Meanwhile, the Certification Commission for Health Information Technology also has concerns. The CCHIT polled nearly 500 healthcare professionals, 29 percent of whom were EHR vendors, in March and found significant numbers who felt Stage 2 measures and objectives "were considered to be too aggressive," wrote Karen Bell, MD, the commission's chairwoman, on the blog EHR Decisions.

Among them? Syndromic surveillance (40 percent of vendors say it’s too soon for this to be a core measure for Stage 2), drug formulary checks, medication reconciliation and clinical decision support.

In general, Bell said, respondents indicated they believe the proposed Stage 2 objectives and measures "could be accomplished by 2012," noting that "many of the features necessary to meet some of these new objectives and measures were already included in EHRs as part of the pre-HITECH EHR certification process."

But she noted "concerns" – especially comments reflecting a "need for further maturation that would take longer than the implementation timeline necessary to have them included in EHR technology by 2014."

"Having these comments is very helpful and is part of the process," said David Blumenthal, MD, the outgoing national coordinator for health IT. "It shows our commitment to continued openness and transparency and making sure that we listen to all points of view.”

He said ONC believes "we have to do everything within our authority to make sure that EHRs and other technologies that we certified and for which we set standards are as user-friendly as possible."

Still, he said: “We’re on track for meaningful use Stage 2."

Senior Editor Patty Enrado contributed to this story.

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