On November 8, 2021, The Department of Health & Human Services (HHS), Office of Inspector General (OIG) released a revised and renamed Provider Self-Disclosure Protocol (SDP), now known as the “Health Care Fraud Self Disclosure “protocol. The SDP was created in 1998, and the protocol can be used to voluntarily identify, disclose and resolve instances of potential fraud involving federal healthcare programs. As described on the OIG website, “Self-disclosures give persons the opportunity to avoid the costs and disruptions associated with a Government-directed investigation and civil or administrative litigation.”
All providers, suppliers or other persons subject to OIG’s Civil Monetary Penalty authorities are eligible to use the SDP while disclosing parties subject to investigations, audits or other oversight activities are not automatically precluded from using the SDP. But, disclosures must be made in good faith and not done in an attempt to circumvent an ongoing investigation.
The OIG noted that between 1998 and 2020, disclosures resulted in recoveries of more than $870 million. Between 2016 and 2020, the OIG resolved 330 SDP cases through settlements, releasing all disclosing parties from exclusion with no integrity measures.
In the revised SDP, OIG doubled the minimum settlement amounts which are required to resolve matters accepted into the SDP. For kickback-related matters, the OIG increased the minimum settlement from $50,000 to $100,000. For all other matters the OIG increased the minimum settlement amount to resolve the matter, from $10,000 up to $20,000.
Those under a Corporate Integrity Agreement (CIA) may use the SDP but they are required to reference that they are subject to a CIA and send a copy of the Disclosure to their OIG monitor. In the revised SDP, the OIG requires parties to provide an estimate of damages. This estimate must include an itemization of damages for each Federal health care program and a total of damages for all Federal health care programs.
The OIG will coordinate with the Department of Justice (DOJ) to resolve civil and criminal matters. The OIG will “advocate that the disclosing party receives a benefit from disclosure under the SDP” for civil matters. In the prior version of the SDP the language of receiving a benefit from disclosure was used with regard to criminal matters. This was taken out by the OIG under the Revised SDP.
Previously, providers could submit disclosures to the SDP via mail, in the revised SDP, the OIG requires that all submissions be made through its website. With the revised SDP, the OIG stated that the SDP is not an appropriate vehicle for disclosures related to recipients of HHS grants, or for federal contractors. These matters should be disclosed through the OIG Grant Self-Disclosure Program and the OIG’s Contractor Self-Disclosure Program.
The OIG recognized that there are benefits to disclose potential fraud. They believe that good faith disclosure of potential fraud and cooperation with OIG’s review and resolution process are indications of a robust and effective compliance program. OIG believes those who use the SDP and cooperate during an investigation, deserve to pay a lower multiplier on single damages than would normally be required in resolving a government-initiated investigation. Each case will be determined individually.
The OIG clarified that using the SDP may mitigate potential exposure under Medicare and Medicaid 60-day reporting and returning requirements for overpayments. Any overpayment retained after this period may create liability under the Civil Monetary Penalties Law and the False Claims Act. The Centers for Medicare & Medicaid Services (CMS) agreed to suspend the obligation to report overpayments under the Act when the OIG acknowledges receipt of a timely submission to the SDP. CMS agreed to suspend the obligation to return overpayments until a settlement agreement is entered into or the provider withdraws or is removed from the SDP. The SDP can prove to be a valuable tool for healthcare providers to use, particularly with the revised SDP which provides a more specific and detailed process that can be relied on and consistently followed.