On April 17, 2013, the Office of Inspector General of the Department of Health and Human Services (“OIG”) released an Updated Provider Self-Disclosure Protocol (“SDP”). The Updated SDP replaces OIG’s original Provider Self-Disclosure Protocol, published in the Federal Register in October 1998, and supersedes OIG’s related open letters from 2006, 2008 and 2009.
The Updated SDP reflects a number of important changes, described below.
Availability of the SDP -
OIG clarified that the SDP is available to drug and device manufacturers, not just health care providers. Consistent with this clarification, throughout the SDP, OIG refers to “disclosing parties” rather than to “providers,” as had been the case in the 1998 Protocol and subsequent open letters.
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