Self-Disclosure for Grant Recipients: New OIG Guidance

In June 2019, the Department of Health and Human Service’ Office of Inspector General (OIG) issued important new guidance on mandatory and voluntary self-disclosures in connection with all DHHS grants, including research awards from NIH, HRSA, and other components and operating divisions. HHS grant recipients and subrecipients are expected to disclose evidence of potential violations of criminal fraud, bribery, or gratuity laws and are encouraged to voluntarily disclose other conduct that might violate civil or administrative laws. The new guidance alerts grant recipients to HHS’s current views on when and how self- disclosures should be made.

Those who receive federal research dollars, including academic medical centers, universities, and small businesses, as well as their subawardees and collaborators, face significant and increasing regulatory oversight and scrutiny. While the OIG has had authority over grantees and subawardees for some time, changes in the 21st Century Cures Act strengthened and emphasized its central role in redressing certain types of grant compliance concerns. The conduct for which self-disclosure may be appropriate ranges from inappropriate cost reporting to false claims.

Grant recipients and subawardees can face high financial penalties as well as exclusion from federal healthcare programs. For investigators, academic medical centers, universities, and others, exclusion, for even temporary time periods, can be disastrous. Federal grant recipients and their counsel must understand the types of violations for which these sanctions may be imposed and as well as the tools for resolving grant compliance concerns, including self-disclosure.

Listen as our authoritative panel of healthcare counsel examines the OIG self-disclosure protocol and the new guidance, and what both mean for HHS grant and federal research recipients and subawardees. The panel will offer best practices for self-disclosure and compliance.

1. OIG's Self-Disclosure Protocol
2. New OIG guidance for HHS grant recipients
3. Best practices for self-disclosure
   1. When to disclose and to whom
   2. Alternatives to self-disclosure
   3. Potential risks of making a self-disclosure
   4. Preserving privileged communications

The panel will review these and other key issues:

• How has the new guidance on self-disclosure altered the playing field for HHS grant recipients?
• What factors should academic medical centers, universities, and other federal grant recipients consider when determining whether and when to disclose a potential Stark law or AKS violation?
• What are the best practices for academic medical centers, universities, and other federal grant recipients and their counsel when preparing the disclosure submission?