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Gaps in Hospital Recalled Device Reporting a ‘Wake-Up Call

Arent Fox Health Care Partner Linda Baumann discussed the potential compliance risks facing hospitals in connection with recalled medical devices for Bloomberg Law in an article titled, “Gaps in Hospital Recalled Device Reporting a ‘Wake-Up Call.’”

 The article reported that according to a  government watchdog group’s findings, Medicare could be vastly overpaying hospitals for recalled medical devices. Furthermore, the article reports that the system has very few ways to  monitor these types of issues. Ms. Baumann said that, “This is kind of a wake-up call [for the industry]” which could face increased government enforcement as well as whistleblower lawsuits as a result.   

The article also highlighted efforts to address the issue including adding unique device identifiers (UDIs) to claims forms, and the Trump Administration’s stance on the issue. According to the article, “Medicare officials are working to ‘determine whether [this] policy would impose an unnecessary burden on physicians.’” Ms. Baumann noted that, “It could signal that there are going to be some real world effects to the Trump Administration review of regulatory burdens.”

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