On May 31, 2017 the Department of Justice announced that EHR vendor eClinicalWorks (ECW) has agreed to settle a whistleblower suit brought under the False Claims Act (FCA) for $155 million. The complaint alleged that ECW’s software did not comply with the government–mandated requirements necessary for it to have received the certification needed under the American Recovery and Reinvestment Act of 2009. Such certification is needed in order to make EHR software eligible for a program allowing its users to receive government subsidies to implement electronic medical records. The government also alleged that ECW paid referral fees to its customers for recommending its software to others in violation of the Anti-Kickback Statute.
This is an unusual example of a FCA case brought against a healthcare information technology company, particularly because the government took over the case, signaling that it wants the industry to take notice. This should serve as a reminder to HIT vendors that when government-certification is necessary for a product, it comes with compliance and enforcement risks and must be taken very seriously.