Since 1998, the Office of the Inspector General of the United States Department of Health and Human Services ("OIG") has published protocols for providers to self-report internal findings of potential fraud. Voluntarily reporting instances of potential fraud is important, because not only does it help maintain integrity in health care systems, but it can also result in significant benefits such as: a lower multiplier on single damages, the mitigation of potential exposure to claims of Medicare or Medicaid overpayment, and the avoidance of the disruption that can be caused by investigation and litigation of potential fraud findings. On November 8, 2021, the regulations not only changed in name, but were amended in a number of ways that impact the process of self-disclosure and provide clarity to its nuances.

What is the Protocol?

All health care providers, suppliers, or other persons that are subject to the OIG's civil monetary penalty authorities ("CMPs") are eligible to use the Health Care Fraud Self-Disclosure Protocol ("SDP"). Conduct more appropriately disclosed through the OIG's Grant Self-Disclosure Program or the OIG's Contractor Self-Disclosure Program is not eligible for disclosure under the SDP and should be pursued through those respective channels. The SDP is restricted to the self-disclosure of the disclosing party, and not the disclosure of another, unrelated party, and should identify the specific laws potentially violated. Some of the potential health care programs include, but are not limited to: Medicare, Medicaid, and TRICARE. The disclosing party is expected to conduct an internal investigation, or must certify that it will do so within 90 days of the date of its initial submission. Broadly, the disclosure requires: requested background information of the disclosing party, a statement of relevant conduct, the identification of the Federal health care programs affected by the disclosed conduct, an estimation of damages, a description of corrective actions taken upon the discovery of the conduct, and other actions depending on the particular fraudulent conduct.

What Has Changed?

The new amendments to the SDP include several procedural changes. The SDP has increased the minimum amounts required to settle. For kickback-related submissions accepted into the SDP, the OIG requires a minimum settlement amount of $100,000 to resolve the matter, and for all other matters the OIG requires $20,000. The SDP also requires submissions through a particular OIG website. Along with procedural changes, the amended SDP now sheds light on areas that may have been unclear. Under these new amendments, it is now clear that parties subject to Corporate Integrity Agreements ("CIA") can use the SDP for self-disclosures. Additionally, the amended SDP clarified that when the Department of Justice ("DOJ") participates in SDP settlements, the DOJ determines the approach in the case and ensures that settlement is consistent with other resolutions under the False Claims Act. The SDP also clarified that disclosers must include damages to each affected Federal health care program, as well as a sum of all damages. Finally, the SDP made several technical changes in regards to statistics, terminology, and background facts.

What Has Stayed the Same?

Amongst the processes and benefits of the SDP that have remained the same are: the timeline for and the content requirements of self-reporting, the methods for calculating damages, and the promise of a timely settlement with a lower multiplier and an exclusion release.

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