In May 2017, the U.S. Department of Justice (DOJ) announced a $155 million settlement with one of the nation’s largest electronic health records vendors—eClinicalWorks (ECW). In its complaint, which was initiated by a whistleblower, the government charged ECW with violations of the False Claims Act (FCA) and the federal Anti-Kickback Statute (AKS) (bit.ly/ECWcomplaint).
While the settlement has been newsworthy for its potential impact on the heavily regulated vendor community (bit.ly/ECWimpact), it also serves as a reminder to all physicians that the DOJ is serious about enforcing these statutes. In this article, I will review this settlement, the statutes that formed the basis for the complaint, and its relevance to practicing urologists.
DOJ alleges false statements
In the recently announced settlement, the DOJ alleges that ECW:
- made false statements about compliance with certain certification criteria. Specifically, the DOJ accused ECW of falsely representing that it was compliant with a functionality to implement a drug vocabulary called RxNorm into its prescribing software. The DOJ further alleged that ECW “hardcoded” the software specifically to pass that portion of the certification test pertaining to RxNorm functionality.
- failed to properly satisfy other certification criteria including data portability, audit logs, imaging orders, and drug interaction checking
- made payments to referral sources and consultants that violate the AKS. Allegations include:
Practices were paid up to $500 for a referral that executed a contract with ECW.
Practices were paid to host site visits based upon the number of potential prospects.
Users were paid up to $250 to be references and a bonus if a purchase was executed.
Fees were paid for promotion of ECW products.
Off-the-books fees were paid to a consultant for sourcing new customers.
ECW, for its part, admitted no wrongdoing under the settlement, and will be subject to further scrutiny under a Corporate Integrity Agreement with the Office of Inspector General (OIG) at the Department of Health and Human Services (bit.ly/ECWsettlement). The whistleblower in the case stands to profit handsomely—by some reports up to $30 million (bit.ly/ECWwhistleblower).