On April 17, 2013—for the first time in fifteen years—the U.S. Department of Health and Human Services Office of the Inspector General (OIG) updated the Provider Self-Disclosure Protocol (SDP). The original SDP was issued in 1998 “to establish a process for healthcare providers to voluntarily identify, disclose, and resolve instances of potential fraud involving the Federal health care programs,” according to the OIG. While the new SDP largely reaffirms the OIG’s positions regarding voluntary disclosure, it provides a formal written statement of these positions. The newly-issued SDP supersedes the 1998 version and makes several notable changes.

  • The new SDP (like the 1998 version) includes general requirements applicable to all disclosures. The new SDP also includes specific requirements for disclosure and investigation of conduct involving (1) false billing, (2) employment of, or contracts with, Excluded Individuals or Entities (defined by the OIG), and (3) the anti-kickback statute.

  • The new SDP reflects a “streamlined” process and requires disclosing providers to complete internal investigations and damages assessments within 90 days from the initial submission.

  • The OIG will generally require a minimum multiplier of 1.5 times the single damages as a condition of settlement, although the SDP also addresses providers that are financially unable to pay.

  • It confirms the presumption against a Corporate Integrity Agreement for settlements reached under the SDP.

  • The new SDP reflects changes made by the Affordable Care Act (ACA). For example, the ACA requires that Medicare and Medicaid overpayments be reported and rectified within 60 days after the provider identifies the overpayment. Under the SDP, that 60-day deadline is tolled while a provider is involved in SDP.

  • The SDP addresses overlap with the separate Stark disclosure protocol and provides for coordination with that program as well as with the Department of Justice in both civil and criminal matters.

  • The SDP emphasizes the OIG’s long-standing support for voluntary disclosures. For hospitals, physicians and all healthcare providers, the SDP reinforces the need for a robust compliance program.