EHRA has complaints about 2015 criteria

'We have much less than a year to design and develop software ... and for our customers to install and test it, and train users'
By Mike Miliard
07:34 AM
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In a letter to National Coordinator for Healthcare Information Technology Karen DeSalvo, MD, the Electronic Health Record Association argues that ONC's proposed Voluntary 2015 Edition Electronic Health Record Certification Criteria rule will cost too much, will disrupt progress and simply isn't "necessary or workable."

[See also: ONC proposes 2015 certification criteria]

Responding to ONC's notice of proposed rulemaking, first announced back in February, the EHR trade association, representing some three-dozen companies, offered its thoughts on both the substance of the proposed 2015 rules and the first hints of potential certification criteria for 2017.

The thrust of the vendors' concerns: "More frequent certification is not desirable and would be costly."

[See also: EHR Association weighs in on Stage 2]

When the rules were first proposed, ONC touted them as a new way of doing things – ostensibly a more nimble approach, characterized by more frequent, but more incremental, rulemaking. The certification criteria reflected the agency's commitment to "efficiently responding to stakeholder feedback," said DeSalvo in a press statement.

Since compliance with the 2015 Edition criteria would be voluntary, EHR vendors with technology certified to the 2014 Edition would not need to re-certify to the new rule set for their customers to be eligible for meaningful use dollars. Likewise, providers would not need to upgrade to 2015 criteria to have systems that qualify as certified EHRs.

"This provides the opportunity for developers and healthcare providers to move to the 2015 edition on their own terms and at their own pace," said DeSalvo at the time.

But the EHR Association doesn't see it that way.

"While framed in the NPRM preamble as being responsive to and addressing EHR developers’ challenges created by uncertain regulatory timelines, this proposed rule focused on a 2015 certification edition and proposing a more frequent certification cadence does not in fact address this issue," wrote Siemens' Michele McGlynn and Allscripts' Leigh Burchell in the letter, also signed by six other executives from companies such as Cerner and McKesson.

"In particular, the proposed rule specifically does not respond to our repeated requests for final rules and all supporting materials and tools at least 18months in advance of when providers and others expect certified products to be available," they write.

Recognizing the voluntary nature of the 2015 requirements, EHR Association members still say they "remain very concerned about market expectations of availability of certified electronic health record technology in an unrealistic timeframe, possibly driven by other government programs that point to the 2015 certification."

They point out that, with the final rule slated for release this summer and with an effective date of 2015, "we have much less than a year to design and develop software that has been designated as a '2015 edition,' and for our customers to install and test it, and train users.

"Knowing that final specifications, test scripts and tools likely will not be available until months after the final rule comes out, we and our customers actually have even less time for all this work," they add.

On top of it all, many of the new criteria are complex, representing a "high development burden (with) minimal evidence of provider demand," the EHR Association argues.

These include changes related to unique device identifier data, new and more complex clinical decision support changes and more "burdensome" drug/drug and drug/allergy interaction tracking.

ONC's plans to move to more frequent certification is counterproductive, says EHRA, moving "in the opposite direction from our request for adequate time to deliver high quality software, and for our customers to prepare to use it in a meaningful and safe way."

Moreover, "it also runs counter to our strong belief that post-2014 certification should be highly focused on interoperability and build on Stage 2," instead of introducing new functionalities.

"We simply do not believe that it is necessary or workable" to continue issuing new certification criteria with more frequent updates, the EHR Association argues.

"We also want to emphasize that, contrary to the notion that this approach of more frequent certification editions 'smooths out' peaks and valleys, we have many other sources of requirements for product functionality, most notably what our customers ask for, as well as other state and federal regulatory requirements," the trade group points out. "We need time and space to work on these, without the need to annually review, comment on and implement ONC certification priorities."

The 2015 Edition criteria are described here.

Read the EHR Association's reponse here.