OIG Self-Disclosure Protocol Redesign After 14 Years

Agency seeks industry comment on self-disclosure protocol to address issues and provide guidance to healthcare industry.

This week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced that it will update its voluntary Provider Self-Disclosure Protocol (SDP or Protocol) and is soliciting suggestions from the public on potential revisions.1 The agency is seeking suggestions on "how best to revise the Protocol to address relevant issues and to provide useful guidance to the health care industry."2

Background

OIG originally published the SDP3 14 years ago, in 1998. Modeled on the Department of Defense's self-disclosure protocol, the SDP offered healthcare providers the opportunity to self-report potential fraud involving federal healthcare programs to OIG. The protocol was published at the same time as Health Insurance Portability and Accountability Act (HIPAA) healthcare fraud enforcement, False Claims Act investigations, and so-called "national enforcement projects" were getting under way. It also coincided with the beginnings of OIG's compliance program guidances for various industry sectors. It was also at this time that Stark Law compliance emerged as a front-burner issue, even though the Centers for Medicare & Medicaid Services (CMS) had not yet finalized its Stark Law regulations or issued a self-disclosure protocol for Stark Law issues.

SDP Usage

While originally intended to expedite resolution of potential fraud matters by shifting the investigative burden to disclosing providers, self-disclosures under the Protocol often are anything but "speedy," largely due to limited OIG resources or a lack of agency prioritization. Partly as a result of this, other self-disclosure options (such as disclosures to states, U.S. Attorneys' offices, or the Department of Justice) have emerged as more nimble and user-friendly. Further, with the advent of the CMS Self-Referral Disclosure Protocol (SRDP) in 2010, providers also have the option of self-disclosing potential Stark Law violations to CMS, although this mechanism is still new and has resulted in relatively few settlements with hospitals and physician practices thus far.4 Settlements of self-disclosures, many of which are summarized by OIG on its website, indicate that most providers have used the SDP to disclose employment of excluded persons, as well as anti-kickback and/or self-referral (Stark Law) issues related to documentation of physician financial...