U.S. Renal Care recently agreed to pay $7.3 million to resolve allegations that Dialysis Corporation of America (DCA) – which the company had acquired in June 2010 – violated the False Claims Act by submitting false claims to Medicare. U.S. Renal Care owns and operates more than 100 freestanding outpatient dialysis facilities throughout the United States.
The settlement resolves allegations that DCA submitted Medicare claims for more Epogen (an intravenous medication that is used to treat anemia, a common condition afflicting patients with end-stage renal disease) than was actually administered to dialysis patients at DCA facilities. Epogen vials contain a small amount of medication in excess of the labeled amount, known as “overfill,” which compensates for medication that might remain in the vial after extraction. According to the U.S. Department of Justice, from January 2004 through May 2011, DCA billed Medicare for 10-11% overfill whenever it administered Epogen.
The whistleblower in the case, Laura Davis, will receive $1,314,000 of the settlement.
Johnson & Johnson’s latest scandal involves international criminal charges in South Korea. Two weeks after Johnson & Johnson was ordered to stop production of two types of Children’s Tylenol syrup because some bottles contained higher amounts of the active ingredient, regulators say that they plan to bring criminal charges against the Janssen unit in South Korea and ban production of five products over the next few months. Further, Jannsen’s Korean CEO Kim Oak-Yeon could face up to three years behind bars.
The charges stem from allegations that when Janssen employees manually placed Tylenol syrup into bottles as new automated facilities were installed in May 2011, they did not completely fill the bottles toward the end of the manufacturing process at the Hyang Nam facility, according to the Yon Hap News Agency. Yet, despite its knowledge of the underfilling problem, Janssen Korea did not notify regulators of the problem until a month later, during which time the company sold about 38,000 bottles of Children’s Tylenol Suspension 100ml and 500ml.
Acting Associate Attorney General Tony West recently defended the U.S. Department of Justice’s track record with whistleblowers during his confirmation hearing before Congress on May 23. “The fact is that whistleblowers have a friend in this Justice Department,” he said, pointing out that the Justice Department has recovered more than $11 billion in taxpayer funds during his 3½ years as the chief of the Civil Division.
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