he government’s increasing ability to analyze Medicare and Medicaid data is changing the role of large-scale data analysis in healthcare investigations — and forcing pharmaceutical and device companies to reevaluate their own internal data practices in anticipation of potential investigations. Discussing some of the new investigation trends facing the industry are Gejaa Gobena, partner in Hogan Lovells’ DC office; and Maria Durant, partner in Hogan Lovells’ Boston office.
What role is data playing in the government’s changing approach to investigations?
Gejaa: “We’re seeing the government lean much harder on data to prove their cases. Not only do they have access to real time Medicare data, they’re using sophisticated algorithms to mine and analyze that data in order to evaluate claims — whether it’s a whistleblower claim in a false claims act suit or allegations around off label marketing that carries serious public health implications.”
Maria: “Certainly with advances in technology and science comes greater risk of potential fraud, abuse, and waste issues. With more money coming from states and the federal government to fund programs that are reimbursing healthcare companies, new potential risk areas are now coming to light. The government is becoming more aggressive in exploring activities it hadn’t explored before. Its ability to mine critical data is fueling that.”
In respect to data, what do pharmaceutical and device companies need to be thinking about?
Gejaa: “What might surprise [these companies] is the extent to which data is being used by the government and the amount of data that they have access to. Looking at using data in a way that allows a company to evaluate potential high-risk areas in their business is something that can only help them, and I think the government is going to expect that companies are using data on their own side to identify issues early.”
Maria: “The role of data is raising some interesting issues for companies in light of what the government is doing, and the extent to which they’re using data. It’s important for companies to think about how they can mine and analyze their own data to identify potential outliers, identify patterns, and take steps to address potential issues before the government comes knocking.”
In what ways should companies anticipate enforcement actions will change?
Maria: “Thanks to the 2015 Yates Memo (guidelines focused on prosecuting individuals within entities, rather than just the entities themselves), corporations now receive credit for cooperating when they identify individuals involved in misconduct. As a result, we are seeing an increase from the U.S. Attorney’s office and the Department of Justice in the felony prosecution of individuals. Yates is having a really complex impact on how we advise clients and how we present information to (the Department of Justice) during an investigation.”
Gejaa: “Of all the developments shaping life sciences investigations these days, one of the most central is the continued focus on individual culpability, and the Yates memo is playing a major role. Now, when there is an internal investigation, the government is going to evaluate not only what data and information you bring to them, but also what you do with executives who might be involved in wrongdoing.”
For more insights on these investigation trends from Gobena and Durant, watch the video above.
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