On April 17th the Department of Health and Human Services Office of Inspector General (OIG) revised provider self-disclosure protocol (SDP). The SDP establishes a process for providers to voluntarily identify and disclose potential cases of fraud involving federal health care programs. This program was first created in 1998, with additional guidance from the OIG being published in 2006, 2008, and 2009 through a series of open letters.
The newly released SDP reaffirms that providers, suppliers and other individuals or entities who are subject to the OIG’s civil money penalties (CMPs) authorities are eligible to use the SDP, and the system for provider self-disclosures does not change. The April revised protocol does, however, include new, key changes to the SDP, which include:
1. Minimum penalty multiplier of 1.5
2. Requires acknowledgement of potential violation of Anti-Kickback Statute (AKS) and/or Stark Law
3. Internal investigations must be certified as complete within 90 days of submission
4. Providers must address specific factors in the kickback analysis
5. Process for calculating damages for disclosures involving the AKS and Stark Law
6. Specific instructions for disclosures regarding excluded persons
7. $10,000 minimum settlement amount for non-kickback submissions
8. Tolling the statute of limitations
9. Advocating to the U.S. Department of Justice for benefits for disclosing parties
10. Corporate Integrity Agreements (CIAs) confirmed as not required to resolve SDP matters
The revised protocol also addressed CMS’ proposed 60-day rule. According to the OIG’s newly proposed rule, provider’s timely submission under the SDP would suspend the 60-day obligation to return overpayments. The OIG stated it will provide additional guidance regarding the SDP and the 60-day rule after CMS releases a final rule.