ONC continues to grapple with how to implement Cures Act provisions
The Office of the National Coordinator for Health Information Technology is still deciding how it will approach implementing the 21st Century Cures Act’s wide-ranging interoperability provisions, according to Acting National Coordinator Jon White, MD.
“I know that a lot of folks have questions about the transition to the new Health IT Advisory Committee that is set forth in the 21st Century Cures Act,” White said at last week’s joint meeting of the Health IT Policy and Standards Committees. “While the timing of the transition to the new Health IT Advisory Committee is a bit uncertain, I want to make it clear that the work of the Policy and Standards Committees is important.”
At the same time, White emphasized that “other things have been afoot in Washington” and that he is “not going to speculate about the future or what the new Administration will have in mind” regarding ONC.
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Section 4003 of the 21st Century Cures Act calls for an “orderly and timely transition” in creating a new Health IT Advisory Committee, which will be established and “shall serve to unify the roles of, and replace, the HIT Policy Committee and the HIT Standards Committee.”
According to the law, the HIT Advisory Committee is to make interoperability a priority and to recommend to the National Coordinator “standards, implementation specifications, and certification criteria, relating to the implementation of a health information technology infrastructure, nationally and locally, that advances the electronic access, exchange and use of health information.”
David McCallie, MD, Cerner’s senior vice president of medical informatics, observes that the legislation has “very broad language, and no regulatory work has started on it yet.” As a result, McCallie contends that “it’s pretty hard to be specific about what it means.” Nonetheless, he believes the 21st Century Cures Act has the potential to be “incredibly important,” but there’s “not a whole lot known about exactly how it’s going to be implemented…the details are what matter, of course.”
Passed by Congress and signed into law by President Obama in December, the 21st Century Cures Act contains several interoperability and health information blocking provisions designed to ensure the flow of healthcare data between providers and EHR vendors like Cerner.
The law codifies new authority for ONC to address interoperability through additional conditions of certification for HIT developers related to: access, use, and exchange of electronic information; usability, security, and business practices; real-world testing; as well as publishing application programming interfaces.
In particular, Robert Tennant, director of health IT policy at the Medical Group Management Association, is encouraged by the Cures Act’s “very strong set of provisions” regarding EHR certification. “Let’s have a long, hard look at our certification process to see if we can improve it and make it more physician-centric,” says Tennant.
McCallie offers that Cerner is “supportive of and appreciative of the focus on interoperability” in the Cures Act. “We are happy to see the legislative effort to increase the value interoperability and frankly to increase the stick—the punishment if information blocking exists.”
In that regard, the Cures Act supports interoperability through several provisions including the prohibition of information blocking and authorization of penalties of as much as $1 million per violation.
However, Micky Tripathi, president and CEO of the Massachusetts eHealth Collaborative, worries that this stick approach could be potentially unfair and unjust, based on the way it is implemented.
Tripathi has concerns about the Cures Act’s “draconian” methods of dealing with “information blocking,” which is defined by the law as practices that are “likely to interfere with, prevent or materially discourage access, exchange or use of electronic health information.”
Given that broad definition of information blocking, he fears that competing providers “could behave badly and use the statute as a stick to beat their competitors in malicious ways,” Tripathi says, offering an example where a healthcare organization might ask a competitor to share electronic health information but is turned down for very practical reasons, such as being in the middle of an EHR transition. “In those cases, the Cures Act gives them an opening to complain to regulators about them—it’s just really ill-considered to introduce at this time.”
Nonetheless, from ONC’s perspective, White said the Cures Act provisions are “very much in alignment with the priorities of achieving nationwide interoperability and a learning health data ecosystem,” adding that “we’re still developing our approach to implementing the Cures Act and the Advisory Committee provision in particular—so, we’ll keep you updated with that as we have news for you.”
In related news, White announced at the HIT Policy-Standards meeting that Andrew Gettinger, MD, ONC’s chief medical information officer, will be serving as Acting Deputy National Coordinator and that Lisa Lewis is continuing in her role as Deputy National Coordinator for Operations.
In addition, he said that Deven McGraw, deputy director for health information privacy at the HHS Office for Civil Rights, will continue at OCR in her current capacity but also has agreed to be ONC Chief Privacy Officer during the transition, replacing Lucia Savage in that job.