The Office of the National Coordinator for Health Information Technology on Thursday announced two major changes to its Health IT Certification Program aimed at improving efficiency and reducing burdens on HIT developers and users.
Under its revisions to the program, ONC has approved developer self-declaration for more than 50 percent of test procedures and has exercised enforcement discretion for randomized surveillance of certified HIT products.
Developers will now self-declare their products’ conformance to ONC-approved test procedures for 30 out of 55 certification criteria, so that they will not have to “spend valuable time testing” with an ONC-Authorized Testing Laboratory, according to the agency.
“By making this change, ONC enables ONC-ATLs and health IT developers to devote more of their resources and focus on the remaining interoperability-oriented criteria, aligning with the tenets of the 21st Century Cures Act,” the agency’ noted in its September 21 blog. “In addition, health IT developers are still required to meet certification criteria requirements and maintain their products’ conformance to the full scope of the criteria.”
At the same time, the agency emphasized that “any non-conformity complaints received and associated with these certification criteria would continue to be reviewed and investigated” by ONC-Authorized Certification Bodies.
When it comes to ONC-ACBs conducting randomized surveillance of certified HIT products, the agency said that it was exercising enforcement discretion and will not—until further notice—audit ONC-ACBs for compliance with randomized surveillance requirements or otherwise take administrative or other action to enforce such requirements.
“This exercise of enforcement discretion will permit ONC-ACBs to prioritize complaint-driven, or reactive, surveillance and allow them to devote their resources to certifying health IT to the 2015 Edition,” according to the agency.
In a conference call, National Coordinator for HIT Donald Rucker, MD, said the changes to the certification program were made “in the spirit of the administration’s review of regulations and reductions.”
Rucker noted that the agency’s two revisions to the program will “reduce the vendor burden” and “hopefully—in part—reduce the vendors’ costs,” which will ultimately trickle down to providers buying their products. He also said the changes will support greater availability of certified HIT for providers participating in the Centers for Medicare and Medicaid Services’ new Quality Payment Program.
However, Karen DeSalvo, MD, former National Coordinator for HIT, was more tepid in her response to ONC’s announcement.
“The certification is relatively young and, just as we did during my tenure as National Coordinator, should be subject to ongoing improvements and modifications,” observed DeSalvo. “That said, our experience and feedback from stakeholders drove us to provide more oversight so we could better protect the safety of care and the financial investments of providers.”
The ONC announcement comes just four months after eClinicalWorks, one of the nation’s largest electronic health record vendors, agreed to pay $155 million as part of a settlement with the Department of Justice for allegedly misrepresenting the capabilities of its software—a charge that has jolted provider confidence.
According to the DOJ allegation, eClinicalWorks falsely obtained certification for its EHR software when it concealed from its certifying entity that its software did not comply with requirements. Likewise, DOJ alleged that because providers used software that did not meet certification requirements, they unknowingly submitted false claims to the Medicare and Medicaid EHR Incentive Program.
The company has denied any wrongdoing. However, with ONC now making the majority of test procedures for health IT products subject to “self-declaration” by developers, it calls into question whether they can be counted on to be truthful about achieving certification for their software.
Nonetheless, Rucker downplayed these concerns. “The reality is these are very public products,” he said. “They have user bases who immediately know if something is working or not working. Let’s say, for example, with CPOE and an order didn’t go through. These things are known almost instantaneously, so that the true bulk of the oversight is provided by the users using the product.”
Rucker pointed out that in the case of DOJ’s settlement with eClinicalWorks the allegation was based on user complaints about the software through complaint-driven, or reactive, surveillance. “It’s what brought the eCW case to light,” added an ONC official. In addition, they noted that self-declaration is not a new approach to certification and is used among other industry testing programs, and that the test procedures for HIT products now designated for self-declaration are for functionality-based certification criteria.
Not surprisingly, reactions from the health IT vendor community to ONC’s revisions to the certification program were overwhelmingly upbeat, praising the agency actions.
“This a positive program change, especially if it forms the foundation of the future testing approach for ONC’s program,” said John Travis, vice president of regulatory and compliance strategy at Cerner. “And, the measures taken to reduce burden in the surveillance program work to appropriately focus the oversight of the ONC-Authorized Certification Bodies to give priority to complaint-driven surveillance.”
Likewise, Sasha TerMaat, chair of EHR Association and director at Epic Systems, expressed support for ONC’s program changes.
“We have encouraged ONC to look for ways to make the certification process less expensive and more efficient,” said TerMaat. “We therefore appreciate the direction and intent of the proposed changes, and look forward to reviewing the details of this new approach.”
However, while Stephanie Zaremba, director of government and regulatory affairs at athenahealth, applauded the move, she contends that the agency did not go far enough in its changes.
“We’re glad to see ONC taking a step to reduce the burden certification places on developers and providers, and look towards a broader reform of the certification program,” said Zaremba. “ONC has an opportunity to go further by supporting and incenting business processes and technology that not only align with government programs, but foster and encourage innovation in service to patient and provider needs.”
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