On November 8, 2021, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) updated (for the first time in years) and renamed its “Provider Self-Disclosure Protocol” to the “Health Care Fraud Self-Disclosure Protocol” (SDP) applicable to disclosure of certain non-compliance with the federal Anti-Kickback Statute (AKS). Why? The OIG explains, in its 14-page Protocol, that “…we identified areas where additional guidance would be beneficial to the health care community and would improve the efficient resolution of SDP matters.”

Of the significant changes:

  • The SDP can now only be submitted online through the OIG’s website;
  • The OIG updated the minimum amount to settle an SDP to $100,000 to meet new statutory penalty amounts[1];
  • The OIG clarified that Corporate Integrity Agreement-reportable events can be reported through the SDP process;
  • The OIG noted that a disclosure under the SDP needs to set forth damages to each federal health care program; and
  • The OIG noted that SDPs can be settled by the DOJ.

Much of the information and calculations that are required in a disclosure under the SDP have not changed from the 2013 Protocol. Timelines, damage calculations and a minimum calculator of 1.5x damages remain constant.

Potential persons considering making a disclosure are tasked with determining whether the SDP or the Stark Self-Disclosure Protocol is the appropriate protocol based on the facts and circumstances of the arrangement in question. The SDP states: “If the arrangement raises a potential violation of only the AKS or of both the AKS and the Stark law, the arrangement should be disclosed to OIG under the SDP.”

The Protocol continues to permit a person making a disclosure to request credits for overpayments, to request consideration if repayment would result in financial hardship, and to request information be redacted under the Freedom of Information Act.

While the changes in the November SDP are not major, reissuing the Protocol reminds health care providers of the benefits of self-reporting if a potential violation of the AKS is discovered through a compliance program, self-audit or otherwise.

[1] Of interest to note is that through the end of September 2021, of the most recent 20 OIG Self-Disclosures reported, 40% involved settlements of less than $100,000.