During the Federal Bar Association’s 2021 Qui Tam Conference, two senior government lawyers—Neeli Ben-David, the Civil Division Deputy Chief and Health Care Fraud Coordinator for the U.S. Attorney’s Office for the Northern District of Georgia and Karen Glassman, Senior Counsel at the U.S. Department of Health and Human Services Office of Inspector General (“HHS-OIG”)—provided insights into how defendants can position themselves for successful engagement with the government and how DOJ and HHS-OIG coordinate behind the scenes to investigate and resolve FCA cases.
Ben-David emphasized the importance of defendants engaging with the government early in an investigation. In order to ensure her office is not pursuing a meritless case, Ben-David encourages defendants to present to the government, particularly where they can articulate, based on a subpoena or CID, the government’s apparent theory of fraud and explain why that theory is “misguided.” Ben-David also finds it helpful when a defendant can demonstrate early on that the company has structured its compliance program so it is consistent with DOJ’s compliance guidance (discussed further here).
Glassman and Ben-David also described how DOJ and HHS-OIG cooperate throughout the life of a healthcare qui tam case. When DOJ’s Civil Division first receives a complaint under seal, they share that complaint with DOJ’s Criminal Division and HHS-OIG. As the investigation proceeds, attorneys from HHS, HHS-OIG, and DOJ often discuss whether the conduct at issue would meet the FCA’s materiality and scienter requirements. In particular, Ben-David noted that her office would not pursue a case based on a violation of the Anti-Kickback Statute or the Stark Law unless HHS-OIG or the Centers for Medicare & Medicaid Services, respectively, are supportive. She further explained that the scienter requirement is particularly important in these cases, and DOJ carefully assess emails or texts associated with the contracts or other formal documentation at issue. Often, just “a dozen documents convince” DOJ to invest further resources in a case. This underscores the importance both of a strong compliance monitoring and auditing function and a robust internal investigation of concerns raised by whistleblowers or the government.
This close inter-agency collaboration may have been strengthened by the False Claims Act Working Group recently announced by HHS. As previously discussed here, the Working Group allows DOJ and various components of HHS to closely coordinate their efforts to focus resources on meritorious FCA cases and avoid burdening companies who have acted in good faith to comply with the law.