On November 8, 2021, OIG released an update to the Self-Disclosure Protocol (SDP). The revised SDP includes a name change for the SDP, increased minimum amounts required to settle under the SDP, a requirement that SDP submissions be made through OIG’s website, and additional clarifications. Fundamental elements of the SDP remain unchanged, such as submission timelines, submission content requirements, and approaches to damages calculations.

The OIG first published the SDP in 1998. The SDP established a process for healthcare providers, suppliers, or other individuals or entities subject to Civil Monetary Penalties (CMPs) to voluntarily report and resolve occurrences of potential fraud involving Federal healthcare programs. The SDP provides guidance on how to investigate conduct, quantify damages, and report conduct to OIG to resolve liability under OIG’s CMP authorities. Between 1998 and 2020, OIG resolved over 2,200 disclosures. Prior to the November 2021 update, the SDP was last amended in 2013.

The November 2021 update to the SDP contains a number of changes, including the following:

• OIG renamed the protocol from the OIG Provider Self-Disclosure Protocol to the OIG Health Care Fraud Self-Disclosure Protocol. Similarly, OIG changed references in the SDP from “health care providers” to “persons,” which is now a defined term that means an individual, trust or estate, partnership, corporation, professional association or corporation, or other entity, public or private.

• OIG increased the minimum settlement amounts for the SDP to match statutory minimum penalty amounts. For kickback related submissions accepted into the SDP, OIG increased its minimum settlement amount from $50,000 to $100,000. For all other matters accepted into the SDP, OIG increased its minimum settlement amount from $10,000 to $20,000.

• OIG now requires SDP disclosures be submitted through OIG’s website. Disclosures by mail will no longer be accepted.

• OIG did not change the methodology for calculating damages under the SDP. However, OIG clarified that the damage estimate should identify the total estimated damages amount for each affected Federal healthcare program and the sum of estimated damages for all affected Federal healthcare programs.

• Like in the prior version, OIG reiterated that disclosing parties under Corporate Integrity Agreements (CIAs) may use the SDP. In the updated version, OIG specified that the disclosure must reference the fact the party is subject to a CIA, the disclosing party must send a copy of the disclosure to the disclosing party’s OIG monitor, and disclosures that are Reportable Events under the CIA must also be disclosed separately to OIG.

• OIG also clarified that the SDP is not suitable for disclosures more appropriately disclosed through the OIG’s Grant Self-Disclosure Program or OIG’s Contractor Self-Disclosure Program.

The updated SDP is available here.