The Sale of Unapproved Medical Devices at Center of $3.3M U.S. False Claims Act Settlement. Exposing Misconduct.

The Sale of Unapproved Medical Devices at Center of $3.3M U.S. False Claims Act Settlement

May 31, 2019

A Federal investigation into alleged false healthcare claims found evidence that New York-based CareFusion Corporation bought and sold “medical devices that were not approved or cleared by the FDA.” CareFusion has agreed to pay the government $3.3 Million after a United States District Attorney for the Southern District of New York announced that the distributor committed civil fraud by violating the False Claims Act.

Medical providers are eligible for federal reimbursement for some of their treatments and services. However, claims made by CareFusion about its medical devices were found to be fraudulent because the medical devices were not approved and uncleared by the FDA. Officials allege False Claims Act violations because the company misrepresented its devices as legal when they were unapproved—allowing other medical providers to seek fraudulent reimbursement claims from Medicare.

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