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Medical Devices / Regulatory Affairs

HHS OIG Work Plan Focuses on Recalled Devices, Cybersecurity

Dec. 28, 2016

The Department of Health and Human Services’ Office of Inspector General (OIG) next year wants to rein in Medicare costs associated with defective medical devices, examine the FDA’s efforts to improve networked device security and crack down on Medicare payments for devices at high risk of fraud and abuse.

According to its 2017 work plan, the OIG will review Medicare claims to identify how much it costs replace recalled devices, given that medical device recalls nearly doubled from 2003 to 2012. The OIG also wants to look at expenses associated with replacing defective implanted devices, in light of previous findings that Medicare administrative contractors made improper payments for such replacements.

The OIG also said it will examine the FDA’s premarket review of networked device cybersecurity controls, as well as procedures for dealing with the consequences of cyber-attacks. — Jeff Kinney

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