On November 8, 2021, the U.S. Department of Health and Human Services – Office of Inspector General (“OIG”) made material revisions to the OIG Self Disclosure Protocol (“SDP”). The SDP was created in 1998 to serve as a mechanism for healthcare providers, suppliers and other entities to voluntarily self-disclose matters involving potential fraud stemming from participation in the federal healthcare programs. The types of fraud reportable under the SDP include submissions of improper claims to federal healthcare programs, potential violations of the federal Anti-Kickback Statute and the physician self-referral law (a.k.a., the “Stark Law”), and employment or contracting with excluded individuals on OIG’s List of Excluded Individuals and Entities.

The SDP’s goal is to facilitate compliance with federal healthcare program requirements by offering entities the opportunity to make good faith disclosures of potential fraud and avoid the costs and disruptions associated with federal investigations and civil or administrative litigation.

The timelines, content requirements and methods used to calculate damages are consistent between the 2013 and 2021 versions of the SDP. The 2021 SDP changes are as follows:

OIG increased the minimum amounts required to settle under the SDP to match new statutory minimum penalty amounts as set forth under the amendments to Section 50412 of the Bipartisan Budget Act of 2018, which increased maximum civil monetary penalties in section 1128A(a) of the Social Security Act (42 USC 1320a-7a) for false claims from $10,000 to $20,000, and for Anti-Kickback Statute-related conduct from $50,000 to $100,000. OIG now requires SDP submissions to be made through the OIG’s web page and online portal, rather than by sending a letter to OIG. OIG clarified that a reporting party must indicate in its disclosure whether it is subject to a corporate integrity agreement. OIG also clarifies that reportable events (as defined by the corporate integrity agreement) can be disclosed under the SDP. OIG made clarifying revisions to the existing language that confirmed the US Department of Justice’s ability to participate in the settlement of cases submitted under the SDP and resolve the matter under the False Claims Act. OIG clarified that a party disclosing under the SDP must include damages to each affected federal healthcare program separately, as well as the sum of all damages to all affected federal healthcare programs. The latest revisions to the SDP are part of OIG’s ongoing evaluation of the disclosure process. OIG previously issued Open Letters to Health Care Providers in 2006, 2008 and 2009 and solicited public comment prior to the 2013 version of the SDP, which amended and replaced the 1998 Federal Register Notice and Open Letters.

OIG reports that it has resolved more than 2,200 disclosures between 1998 and 2020, resulting in recoveries of more than $870 million to the federal healthcare programs. Between 2016 and 2020, OIG resolved more than 330 settlements through the SDP. According to OIG’s web page, OIG has entered into more than 600 settlements since 2013 with organizations that self-disclosed conduct through the SDP, with settlements as high as $20.9 million.

For additional information regarding the revised SDP, use the following link: https://oig.hhs.gov/documents/self-disclosure-info/1006/Self-Disclosure-Protocol-2021.pdf

Law Offices of George W. Bodenger has significant experience in guiding clients through the OIG Self Disclosure Protocol process. Please contact us at gwb@bodengerlaw.com or at (610) 212-5031 to learn more about our qualifications and experience in this area.