On May 31, 2017, the DOJ announced a $155 million settlement with eClinicalWorks (ECW), one of the nation’s largest electronic health records (EHR) vendors, to resolve a False Claims Act lawsuit brought by a whistleblower.  The lawsuit alleged that ECW misrepresented capabilities of its software allowing it to falsely obtain EHR certification.  The settlement also resolves allegations that ECW paid kickbacks to some customers to promote its EHR software.  As part of the settlement, ECW entered into a corporate integrity agreement (CIA).

The Medicare and Medicaid EHR Incentive Programs encourages healthcare providers to adopt and “meaningfully use” certified EHR technology.  Under the program, HHS provides incentive payments to providers that implement certified EHR technology and meet certain requirements.  Software companies certify their EHR software by attesting that their products satisfy criteria promulgated by HHS and by passing a test administered by an accredited independent certifying entity approved by HHS.

In the complaint-in-intervention, available here, the Government alleges that ECW concealed from its independent certifying entity that its EHR software failed to comply with certification requirements.  For example, the government contends that ECW modified its software to “hardcode” only the 16 drug codes required for testing, rather than the software’s complete drug code database.  Additional allegations include that ECW’s software did not accurately record user actions in audit logs, did not meet data portability requirements, failed to perform required drug interaction verification, and did not always accurately record diagnostic imaging orders.

Under the settlement, ECW entered into a CIA, available here, with the HHS OIG.  The five-year CIA requires ECW to retain an Independent Software Quality Oversight Organization to review and assess ECW software and report its findings and recommendations to both ECW leadership and the OIG. ECW must also notify customers, through its online portal, of any safety related issues and procedures customers should undertake to mitigate such risks.  Under the CIA, ECW is obligated to upgrade customer software free of charge and provide customers the option to transfer their data to another EHR vendor without penalty or at any cost to the provider. Finally, ECW must retain an Independent Review Organization to ensure ECW’s provider arrangements comply with the Anti-Kickback Statute.