Millennium Settles False Claims Allegations for $256 Million

After winning a procedural victory on appeal in litigation brought by Ameritox claiming unfair competition based on alleged violations of the Anti-kickback statute (AKS) and Stark Law Millennium Health has confirmed it will be paying out three settlements totaling $256 million to resolve False Claims Act and Anti-kickback allegations. It will be paying an aggregate $256 million settlement as follows:

• $227 million settling False Claims allegations of unnecessary urine drug testing between Jan. 1, 2008 and May 20, 2015 through use of custom profiles and standing orders rather than individualized assessment of patient testing needs. The allegations also included claims that free point of care testing cups were provided to physicians in violation of the AKS and Stark Law.
• $10 million for False Claims allegations that genetic testing between Jan. 2012 and May 20, 2015 was routinely performed without regard to individualized need assessment.
• $19.2 million to Centers for Medicare and Medicaid Services with regard to urine drug test billing.

Millennium has also agreed to enter into a five-year Corporate Integrity Agreement with the Office of Inspector General. The settlement of the claims, however, involves no determination of liability and Millennium's Chief Executive Officer Brock Hardaway indicated in a statement the company "may debate some of the merits of the DOJ's allegations" but respects the government's enforcement role and sought closure to a lengthy investigation. Hardaway also stressed the company is a "very different organization" than in the past and the DOJ's settlement announcement acknowledges the company has overhauled its board of directors with mostly new independent members. The company also indicated intentions to pursue restructuring.