May 17, 2022

Volume XII, Number 137

Advertisement
Advertisement

May 16, 2022

Subscribe to Latest Legal News and Analysis
Advertisement

OIG’s Revised Self-Disclosure Protocol: Top Takeaways

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). This is the first revision to the SDP since 2013.

The SDP is limited to matters that involve potential violations of Federal criminal, civil or administrative law for which civil monetary penalties (CMPs) are authorized. As described on the OIG website, “Self-disclosure gives persons the opportunity to avoid the costs and disruptions associated with a Government-directed investigation and civil or administrative litigation.” One expectation of the SDP is that the provider or supplier identify its corrective action(s). Specifically, the problematic conduct should have stopped prior to disclosure or be in the process of termination, and all other necessary corrective action should be complete and effective at the time of disclosure. 

Below, we describe the top takeaways from the revised SDP and what organizations should know before starting the self-disclosure process.

Minimum Settlement Amounts: Doubled

In the revised SDP, OIG doubles the minimum settlement amounts required to resolve matters accepted into the SDP. For kickback related matters, OIG increased the minimum settlement amount from $50,000 to $100,000. For all other matters accepted into the SDP, OIG increased the minimum settlement amount from $10,000 to $20,000. These increases track the increased CMP maximum imposed by the Bipartisan Budget Act of 2018. (Current CMP maximum adjusted penalties can be found at 45 C.F.R. § 102.3.)

OIG’s Grant and Contractor Self-Disclosure Programs

With the revised SDP, OIG clarifies that the SDP is not an appropriate vehicle for disclosures related to recipients of HHS grants, or for federal contractors. Rather, OIG states that these matters should be disclosed through OIG’s Grant Self-Disclosure Program and OIG’s Contractor Self-Disclosure Program.

Organizations under Corporate Integrity Agreements (CIA)

OIG allows organizations under CIAs to use the SDP, but with this revision, 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. OIG clarifies that 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. With the revised SDP, OIG clarifies that this estimate must include an itemization of damages for each Federal health care program, and a total of damages for all Federal health care programs.

OIG’s Coordination with the Department of Justice (DOJ)

In the SDP, OIG states that it will coordinate with DOJ to resolve civil and criminal matters. OIG states that it will “advocate that the disclosing party receives a benefit from disclosure under the SDP” for civil matters. In the last [prior] version of the SDP, OIG included this same language regarding criminal matters. However, OIG removed this reference for criminal matters in the revised SDP. Whether the SDP’s current advocacy limitation to civil matters will be significant will, of course, remain to be seen as new cases work their way through the SDP process. The Sentencing Guidelines used for criminal cases continue to reflect “credit” for compliance efforts, but the SDP’s advocacy change may reflect an increasing intolerance for health care fraud that is thought to rise to a level of criminality, or it may reflect a realignment of delegation enforcement authorities. OIG also notes that any disclosure of criminal conduct through the SDP will be referred to DOJ for resolution. 

Updated Statistics

OIG provided updated statistics regarding the SDP process. Specifically, between 1998 and 2020, OIG has resolved over 2,200 disclosures, which resulted in OIG recovering more than $870 million for Federal health care programs. Between 2016 and 2020, OIG resolved 330 SDP cases through settlements, and released all disclosing parties from permissive exclusion without requiring any integrity measures. 

Online Submission Required

OIG previously allowed organizations to submit disclosures to the SDP via mail. With the revised SDP, OIG is now requiring all submissions through its website.

Conclusion

OIG’s revised SDP confirms OIG’s continued expectation that providers and suppliers will identify, rectify, and resolve instances of potential fraud involving the Federal health care programs. In essence, the SDP provides an “exit strategy” for resolution of risk. To take advantage of the SDP, providers and suppliers must have an active and effective compliance program that can identify potentially fraudulent conduct and be able to stop it and address the consequences. 

© 2022 Foley & Lardner LLPNational Law Review, Volume XI, Number 312
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

Judith Waltz, False Claims Act Attorney, Foley Lardner Law Firm
Partner

Judith A. Waltz is a partner and business lawyer with Foley & Lardner LLP. Her practice focuses on government investigations, false claims act, corporate integrity agreements (CIAs), bankruptcy, and Medicare and Medicaid counseling. Ms. Waltz works with clients in various areas of the health care industry. She is former co-chair of the firm’s Life Sciences Industry Team, and former vice chair of the Health Care Industry Team. Ms. Waltz is also a member of the Government Enforcement, Compliance & White Collar Defense and Bankruptcy & Business Reorganizations...

415-438-6412
Olivia King Health Care Lawyer Foley Lardner Boston
Associate

Olivia King is an associate with Foley & Lardner LLP and a member of the firm’s Health Care Industry Team.

Olivia was selected for the inaugural Mayo-Foley Health Law Fellowship, consisting of summer internships with the Mayo Clinic Legal Department in Rochester, Minnesota (2017), and Foley (2018).While at the Mayo Clinic, Olivia researched and prepared memorandum on state and federal medical prescribing and licensure requirements with analysis of potential implications on telemedicine initiatives and state mental health ombudsman reporting...

617.226.3165
Advertisement
Advertisement
Advertisement