Trending Video: DOJ Enforcement Update: Electronic Health Records

Practices: Government Enforcement / White Collar Criminal Defense, Health Care, Digital Health, False Claims Act

Joshua Levy, co-chair of Ropes & Gray’s litigation & enforcement practice, provides an update on the enforcement of electronic health records by the Department of Justice (DOJ).


My name is Joshua Levy and I'm the co-chair of Ropes & Gray's litigation & enforcement group, and I'm a former federal prosecutor, having spent seven years with the Department of Justice. I want to talk to you today about the emerging trend of enforcement by the Department of Justice in the electronic health records space.

HITECH Act and electronic health records

This actually goes back to 2009, when in the midst of the financial crisis, Congress passed the HITECH Act, which provided for over $30 billion in incentive payments to physicians and hospitals for migrating from paper records to electronic health records entering the digital age. The system set up by Congress provided that tech companies that created electronic health record systems needed to be certified by the federal government for meeting the criteria set forth by Congress. If physicians made meaningful use of their software, the physicians received these incentive payments from the federal government, like I said, totaled several billion dollars. Congress passed that law and then the Department of Justice started enforcing in the False Claims Act space in 2017 around potential misconduct in how these companies were certified.

DOJ’s pursuit of EHR violations

The first case was against a company called eClinicalWorks, which was accused of cheating on the test to get their software certified in allowing these physicians to receive the incentive payments. There was another settlement for about $50 million in 2019. And then just in January 2020, a significant $145 million settlement was announced by the Department of Justice against another electronic health records company. In a new twist in that case, the case involved not only allegations that the company had cheated on the test to get their software certified, but also they had entered an illegal kickback arrangement with a pharmaceutical company in order to promote that company's product on the software platform. That case really takes the enforcement area in electronic health records to a whole new realm, beyond just the tech company and looking into the relationship between pharmaceutical companies, medical device companies and EHR companies.

Looking ahead: continued enforcement

This is going to continue to be a trend, and don't take my word for it – the Assistant Attorney General of the United States for the Civil Division, Jody Hunt, announced in February 2020 that electronic health records enforcement was one of the top three priorities for the Department of Justice in the coming year. So as companies think about value-based health care, data mining, data analytics, they need to be thinking about their relationship with the tech companies that help them further their business goals. 

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