Stakeholders unhappy with ONC 2015 rule

Stakeholders unhappy with ONC's 2015 rule
By Mike Miliard
03:51 PM
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Healthcare industry groups are not happy about the Voluntary 2015 Edition Electronic Health Record Certification Criteria rule that's been proposed by the Office of the National Coordinator.

When the criteria were first proposed this past February, 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 National Coordinator for Healthcare Information Technology Karen DeSalvo, MD in a press statement at the time.

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.

One wonders if ONC was taken aback by the volume and vehemence of the opposition, voiced by an array of different constituencies. 

In a letter to DeSalvo, the Electronic Health Record Association argued 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."

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

"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.

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

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 plan to move to more frequent certification is counterproductive, said EHRA members, 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, EHRA argued.

"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 pointed out. "We need time and space to work on these, without the need to annually review, comment on and implement ONC certification priorities."

Writing on his blog back in February, John Halamka, MD, chief information officer of Beth Israel Deaconess Medical Center in Boston echoed those concerns. 

"The logic behind more frequent certification rules is that it enables 'bug fixes' and more rapid adoption of standards. However, we should ask the question – even with a voluntary program, just how fast can we develop software, install upgrades, revise workflow, educate clinicians and support new software versions? My experience is that changes of this nature take three years from regulation to attestation, at a minimum."

'Confusion and … unintended consequences'

Other industry stakeholders had their own sets of concerns about the proposed certification rule.

For its part, the American Medical Association complained to DeSalvo that its membership finds the meaningful use process too "rigid," and argued that the certification process should be more focused on "ensuring interoperable and usable systems." AMA reemphasized its belief that "the MU program and certification process must be substantially overhauled so physicians can leverage technology to help ensure improvements in health care delivery."

The American Hospital Association expressed concerns that this new approach would simply mean more red tape, and argues that the timetable is too short, with the "regulatory pace between final rule publication and start of compliance" not in keeping with "the ability of providers and vendors to adjust.

"The AHA strongly recommends ONC first focus on collaborating with the Centers for Medicare & Medicaid Services to clarify current 2014 edition certification criteria and implementation specifications to ensure that providers will be able to receive and use certified EHRs in a timeframe that enables successful attestation to meaningful use," wrote Linda E. Fishman, AHA's senior vice president of public policy analysis and development.

The Telecommunications Industry Association, meanwhile, requested that ONC remember that health information technology is "not solely EHRs and EHR systems, but also includes mHealth, e-Care, telemedicine and eHealth."

Brian Scarpelli, the TIA's director of government affairs, wrote to DeSalvo that, "In crafting its 2015 certification criteria (and further editions moving forward) as well as its efforts generally to improve the U.S. healthcare system, we urge ONC to fully appreciate the health information technology ecosystem," from remote monitoring devices to smartphones.

One positive note came from the Consumer Partnership for eHealth, which called the draft 2015 Edition a step in the right direction for better, more equitable health outcomes.

"If adopted, the Proposed Rule is an important next step in the ongoing effort to make sure EHR technology includes essential functionalities that will help meet the needs of patients and families," said Debra L. Ness, president, National Partnership for Women & Families, which leads CPeH, in a press statement. "We are pleased the proposed rule advances the goal of leveraging the Meaningful Use Incentive Program to better identify and reduce health disparities, which are a pervasive and costly problem in our country."

CPeH did offer several recommendations to ONC, however, such as requiring EHRs to more granularly collect and filter patients' race and ethnicity and offer patient-specific education resources in that patient's preferred language.

Noting that more than 60 million Americans speak a language other than English at home, CPeH argued that, "at the very least, the 2015 edition should be able to provide 100 percent of education materials in Spanish. By 2017, EHRs should provide education materials in at least the top five national languages."