OIG Updates Self-Disclosure Protocol | King and Spalding
On November 8, 2021, OIG released an update to the Self-Disclosure Protocol (SDP). The revised SDP includes a name change for the SDP, an increase in the minimum amounts required to pay under the SDP, a requirement that SDP submissions be made through the OIG website, and additional clarifications. The fundamentals of the SDP remain unchanged, such as submission deadlines, submission content requirements, and damage calculation approaches.
The OIG first published the SDP in 1998. The SDP established a process for healthcare providers, providers, or other persons or entities subject to Civil Monetary Penalties (CMPs) to report and voluntarily resolve cases of potential fraud involving federal health programs. The SDP provides guidance on how to investigate a conduct, quantify damage, and report a conduct to the OIG to resolve liability under the OIG’s CMP authorities. Between 1998 and 2020, the OIG resolved over 2,200 disclosures. Prior to the November 2021 update, the SDP was last changed in 2013.
The November 2021 SDP update contains a number of changes, including the following:
The OIG renamed the OIG Supplier Self-Disclosure Protocol protocol to the OIG Healthcare Fraud Self-Disclosure Protocol. Likewise, the OIG changed the references in the SDP from “health care providers” to “persons”, which is now a defined term meaning an individual, a trust or estate, a partnership, a corporation, an association. professional or company, or other entity, public or private.
The OIG has increased the minimum settlement amounts for the SDP to match the statutory minimum penalty amounts. For bribe-related submissions accepted in the SDP, the OIG has increased its minimum settlement amount from $ 50,000 to $ 100,000. For all other matters accepted in the PLS, OIG has increased its minimum settlement amount from $ 10,000 to $ 20,000.
The OIG now requires that SDP disclosures be submitted through the OIG website. Disclosures by mail will no longer be accepted.
The OIG has not changed the methodology for calculating damages under the SDP. However, the OIG clarified that the damage estimate should identify the total estimated damage amount for each affected federal health program and the sum of the estimated damage for all affected federal health programs.
As in the previous version, the OIG reiterated that disclosing parties under Corporate Integrity Agreements (CIAs) can use the SDP. In the updated version, the OIG clarified that the disclosure should refer to the party being subject to a CIA, the disclosing party should send a copy of the disclosure to the disclosing party’s OIG controller, and the disclosures which are reportable events under the CIA must also be disclosed separately to the OIG.
The OIG also clarified that the SDP is not suited to disclosures more appropriately disclosed through the OIG Grants Self-Disclosure Program or the OIG Entrepreneur Self-Disclosure Program.
The updated SDP is available here.