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. The OIG “Health Care Fraud Self-Disclosure Protocol” (SDP) is the first revision to the SDP since 2013. The Self-Disclosure Protocol is available only for matters that involve potential violations of federal criminal, civil, or administrative law for which civil monetary penalties (CMPs) are authorized. The OIG’s updated website provides that “Self-disclosure gives persons the opportunity to avoid the costs and disruptions associated with a Government-directed investigation and civil or administrative litigation.” The SDP expects that “the disclosing party should ensure that the conduct has ended or, at least, in the case of an improper kickback arrangement, that corrective action will be taken and the improper arrangement will be terminated within 90 days of submission to the SDP.” The Protocol also expects providers to complete all other necessary corrective action by the time of disclosure.
The following are several key takeaways from the revised SDP and highlight information that providers should be aware of before beginning the self-disclosure process:
- Minimum Settlement Amounts Doubled. The revised SDP doubles the minimum settlement amounts required to resolve matters accepted into the SDP. When the matter is related to kickbacks, the minimum settlement amount has been increased from $50,000 to $100,000. For all other matters, the minimum settlement amount has been increased from $10,000 to $20,000. These increases follow the increased CMP maximum imposed by the Bipartisan Budget Act of 2018.
- Grant and Contractor Self-Disclosure Programs. OIG clarified in the revised SDP that the Protocol is not an appropriate vehicle for disclosures related to recipients of HHS grants or those for federal contractors. OIG states that these matters should be disclosed through OIG’s Grant Self-Disclosure Program and Contractor Self-Disclosure Program accordingly.
- Organizations under Corporate Integrity Agreements (CIAs). OIG continues to allow organizations under CIAs to use the SDP, however the revised SDP requires the organization to reference the fact that it is subject to a CIA and send a copy of the disclosure to its OIG monitor. Any disclosure that constitutes a reportable event (as defined by the CIA) must be reported to OIG.
- Itemized Damages. OIG requires that parties provide an estimate of damages. OIG clarified in the revised SDP that this estimate must include an itemization of damages for each federal healthcare program and a total of damages for all federal healthcare programs.
- OIG’s Coordination with the Department of Justice (DOJ). The revised SDP states that OIG will coordinate with DOJ to resolve civil and criminal matters. Specifically, that “OIG will advocate that the disclosing party receive a benefit from disclosure under the SDP” for civil matters. The prior version of the SDP included this same language regarding criminal matters, however OIG removed this reference in the revised SDP. OIG further notes that “any disclosure of criminal conduct through the SDP will be referred to DOJ for resolution.”
- Online Submission Requirement. All submissions to the SDP must now be made using the online submission form, which can be found at the updated website, linked above. Previously, OIG allowed organizations to submit disclosures to the SDP via mail.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters. If you or your healthcare entity has any questions pertaining to healthcare fraud disclosures or healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or firstname.lastname@example.org.