Life Sciences

OIG addresses self-disclosure protocol

Device Regulation Alert: Safety, Compliance and Reimbursement News, May 19, 2008

A new Open Letter from the OIG provides additional requirements for self-disclosure reports that will streamline the reporting process.
 
In addition to the Basic Information, self-disclosure protocols should include:
  • A description of conduct
  • An explanation of internal investigation or promise of when it will be completed
  • An estimate of damages and how they were calculated
  • What laws potentially were broken
The OIG requires entities complete an assessment of damages within three months after beginning participation in the protocol and the OIG has revamped its processes to speed resolution of disclosure reports. Billing errors or overpayments should not be reported through the self-disclosure protocol but rather to the Medicare contractor.  

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