Sunday, December 3, 2023

The OIG Self-Disclosure Protocol: A Valuable Tool in Effective Compliance - Lexology

In FY 2021, investigations led by the Department of Health and Human Services’ Office of Inspector General (OIG) resulted in 504 criminal actions against individuals or entities that engaged in crimes related to Medicare and Medicaid, and 669 civil actions, which included false claims and unjust-enrichment lawsuits filed in federal district court, and civil monetary penalty (CMP) settlements.

When a healthcare provider realizes the entity may have violated federal healthcare laws or requirements, it is often the best course of action to report the violation instead of waiting for the Government to potentially investigate the violation and bring criminal and/or civil action.

Health care providers, suppliers, or other individuals or entities subject to Civil Monetary Penalties can use the Provider Self-Disclosure Protocol (SDP) to voluntarily identify, disclose, and resolve instances of potential fraud involving the Federal health care programs (as defined in section 1128B(f) of the Social Security Act (the Act), 42 U.S.C. 1320a–7b(f)). The SDP provides guidance on how to investigate this conduct, quantify damages, and report the conduct to OIG to resolve the provider’s liability under the OIG’s CMP authorities. A large category of SDP submissions relates to potential violations of the Anti-Kickback Statute (AKS) (including conduct that violates both the AKS and the Stark law.) AKS compliance is a condition of payment of the Federal health care programs. Under section...

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