The Case for Federal Oversight of EHR Vendors to Promote Interoperability and Usability

James Hofert

Guest post by James Hofert, Roy Bossen, Linnea Schramm and Michael Dowell of Hinshaw & Culbertson.

In 2013, healthcare industry stakeholders, including associations, EHR vendors, practitioners and providers, raised significant concerns relating to the implementation timing of meaningful use Stage 2 and 3 criteria, including problems with interoperability, usability and regulatory failure to assess “value added” by implementation of meaningful use criteria to date. On December 6, 2013, federal officials announced that Centers for Medicare and Medicaid Services (“CMS”) were proposing a new timeline for the implementation of meaningful use stage criteria for the Medicare and Medicaid Electronic Health Record (“EHR”) incentive programs. The Office of the National Coordinator for Health Information Technology (“ONC”) further proposed a more regular approach for the update of ONC’s certification regulations.

Under the revised timeline, Stage 2 will be extended through 2016 and Stage 3 will begin in 2017 for those providers had completed at least two years in Stage 2. The goal of the proposed changes is twofold; to allow CMS and ONC to focus efforts on the successful implementation of the enhanced patient engagement, interoperability and health information exchange requirements in Stage 2, as well as evaluate data from Stage 1 and Stage 2 compliance, to date, to create and form policy decisions for Stage 3.

Roy Bossen

CMS expects to release proposed rulemaking for Stage 3 in the fall of 2014, which may further define this proposed new timeline. Stage 3 final rules would follow in the first half of 2015.

Despite CMS’s positive response to stakeholders concerns relating to the timeline for implementation of Stage 2 and Stage 3 meaningful use criteria, significant reservations continue to be enunciated, on a monthly basis, by providers at both Health information technology (“HIT”) policy committee and work group meetings. Providers continue to urge rule makers to institute consensus standards that could be adopted broadly across the healthcare industry to ensure both usability and interoperability.

In early 2013, former national coordinate Farzad Mostashar chastised electronic health record vendors for improper behavior in the marketing and sales of systems that continued to frustrate interoperability goals. This frustration with EHR vendors continues to be enunciated in HIT policy committee and work group meetings as recently as January of 2014.

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