DOJ: Alere Unit Billed Medicare For Diabetic Testing Supplies For The Dead
Alere Medical and its now-defunct subsidiary Arriva Medical will pay the US government $160m to settle allegations that they violated the False Claims Act. It’s the second settlement that Alere has entered into with the Department of Justice in recent weeks.
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The settlements resolve False Claims Act allegations against St. Jude and Alere, as well as misbranding allegations against Avanos Medical.
Alere subsidiary Arriva Medical routinely gave Medicare beneficiaries glucometers they didn’t need and billed the government for them, a recently unsealed lawsuit claims.
In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down.