Fresenius Beats FCA Lawsuit: Court Holds That Owner of Renal Dialysis Facilities Never “Knowingly” Submitted False Claims for Drug “Overfill”

American Health Lawyers Association

Daniel C. Fundakowski, an Associate in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an American Health Lawyers Association Email Alert titled “Fresenius Beats FCA Lawsuit: Court Holds That Owner of Renal Dialysis Facilities Never ‘Knowingly’ Submitted False Claims for Drug ‘Overfill.’”

Following is an excerpt:

On October 30, the U.S. District Court for the Northern District of Georgia dismissed a False Claims Act (FCA) case alleging that Fresenius Medical Care Holdings Inc. (Fresenius) submitted false claims for dialysis drugs that the company received for free. …

The case was filed in 2010 by a former employee, alleging that the company unlawfully billed Medicare for “overfill” (the amount of a drug contained in a vial in excess of the labeled amount) of end stage renal disease drugs Epogen and Zemplar from 2006 through 2010. … Fresenius, the country’s largest owner of outpatient renal dialysis facilities, was allegedly extracting not only the entire labeled amount of medicine in a vial, but also the overfill. Fresenius would then allegedly administer the overfill as part of a patient’s treatment and bill payers (including Medicare) for the administration.