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US WorldMeds LLC, Medicare Kickback Scheme, USA 2023

Pharmaceutical behemoth US WorldMeds LLC has copped to a massive $17.5 million fine in a landmark fraud settlement with the Department of Justice (DOJ). The company stands accused of doling out illegal kickbacks to Medicare patients and physicians, a brazen move aimed at boosting sales for its drugs Apokyn® and Myobloc®.

Assistant Attorney General Jody Hunt from the DOJ’s Civil Division was unambiguous in her statement: “The Department of Justice is committed to ensuring that physicians’ and patients’ selection of medications is not influenced by improper financial considerations.” She emphasized that health care companies must adhere to the rulebook, especially the Anti-Kickback Statute.

“Pharmaceutical companies that pay kickbacks to improperly induce drug prescriptions drive up the costs of health care,” said U.S. Attorney John H. Durham for the District of Connecticut. “The whistleblowers who exposed this scheme will be rewarded, and we encourage others to come forward.”

The settlement centers on allegations that USWM hiked the price of Apokyn in 2012, leading to skyrocketing copays for many patients. It’s claimed the company then illegally paid these copays through a third-party foundation, knowing it was the sole donor and that nearly all funds went to Medicare Apokyn patients.

Furthermore, the U.S. government accused USWM of paying kickbacks to physicians in the form of excessive speaking fees and lavish entertainment, including private plane rides and trips to high-profile events like the Kentucky Derby.

In parallel with the False Claims Act settlement, USWM has signed a Corporate Integrity Agreement with the Department of Health and Human Services, Office of Inspector General. This five-year agreement mandates stringent compliance measures, including independent reviews, executive certifications, and a risk assessment and mitigation process.

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