The Department of Health and Human Services Office of Inspector General (“OIG”) issued an Updated Provider Self-Disclosure Protocol (“SDP”) on April 17, 2013 which supersedes the original SDP published in 1998 and three later-released open letters that provided additional guidance. The SDP clarifies that it is only available for “all health care providers, suppliers, or other individuals or entities who are subject to OIG’s Civil Monetary Penalties (“CMP”). The notable exclusion is violation of the Physician Self-Referral Law (a.k.a. “Stark Law”) – self-disclosure of Stark Law violations can instead be disclosed through a similar Self-Referral Disclosure Protocol through the Centers for Medicare and Medicaid Services (“CMS”). The OIG also notes that the self-disclosure process is not an alternative means for seeking an OIG opinion regarding whether an actual or potential violation has occurred.

Importantly, because good faith disclosure of potential fraud through the SDP is a sign of a “robust and effective compliance program,” the OIG has instituted a presumption against requiring integrity agreement obligations in exchange for a release of the OIG’s permissive exclusion authorities.

When the SDP is used, the disclosing party must agree to waive pleading of statute of limitations, laches, and other similar defenses, so as not to simply use the self-disclosure process as a device to delay OIG investigation past the statute of limitations. The disclosing party must also ensure that corrective action is taken to resolve any impropriety. The SDP outlines 11 core requirements for all disclosures and then sets out specific subsets of requirements for false billing disclosures, conduct involving excluded persons, and conduct involving the Anti-Kickback Statute or Stark Law.

The SDP states that self-disclosing parties should expect to repay more than single damages, and that the OIG’s general practice is 1.5 times single damages. A minimum $50,000 settlement is required for any case accepted into the SDP. If a self-disclosing party does not believe it can afford the penalties, it must disclose pertinent financial information to support its belief.

The full Updated OIG’s Provider Self-Disclosure Protocol is available here. In addition, the OIG updated its SDP training video and issued a new podcast explaining the changes. These are available through the OIG website.

For more information regarding the Updated OIG’s updated SDP, and for other matters regarding self-disclosure and the related underlying law, please contact Abby Pendleton, Esq., Adrienne Dresevic, Esq., Carey Kalmowitz, Esq., or Rob Iwrey, Esq. at (248) 996-8510.

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