OIG Revises Self-Disclosure Protocol

On Nov. 8, the OIG did something it hadn’t done since 2013: It revised the Provider Self-Disclosure Protocol. Here’s a look at the six key changes to the protocol, which now has a new name, the Health Care Fraud Self-Disclosure Protocol (SDP)

What the SDP Does

First published in 1998, the SDP establishes a framework and process for labs and other providers to voluntarily disclose and resolve self-discovered overpayments, improper Anti-Kickback Statute (AKS) violations and other acts of potential fraud involving federal government health programs. According to the OIG, “self-disclosure gives persons the opportunity to avoid the costs and disruptions associated with a Government-directed investigation and civil or administrative litigation.”

The OIG has modified the SDP several times over the years in an effort to make it clearer and more attractive to providers, most notably in April 2013 when the agency added substantial new guidance on how to assemble the content included in disclosures and transparency into the process the agency uses to resolve matters disclosed.

The 6 Key SDP Changes

While less impactful than the 2013 changes, the new 2021 revisions include a number of significant provisions. Specifically, there are 6 changes lab compliance managers need to be aware of when deciding whether to pursue self-disclosure through the SDP:

1. Minimum Settlement Amounts Doubled

To keep up with increases to the maximum civil monetary penalty (CMP) amounts imposed in 2018, the OIG has doubled the minimum settlement amounts required to resolve matters using the SDP:

• From $50,000 to $100,000 for kickback related matters; and
• From $10,000 to $20,000 for all other matters.

Bottom Line: Don’t rely on the SDP if the potential fraud you uncover involves an amount less than the new minimums.

2. New Requirement to Itemize Damages

While labs will still have to provide an estimate of damages, the new SDP requires the estimate to include an itemization of damages for each federal health care program, e.g., Medicare, Medicaid, TRICARE, etc., as well as a sum total estimate of damages for all programs.

3. Self-Disclosure for Grants & Contractors

The revised SDP clarifies that the SDP shouldn’t be used for disclosures related to recipients of HHS grants, or for federal contractors. Instead, those matters should be disclosed via OIG’s Grant Self-Disclosure Program and OIG’s Contractor Self-Disclosure Program.

4. Disclosing Parties under Corporate Integrity Agreements

As before, organizations that are currently under Corporate Integrity Agreements (CIAs) are allowed to use the SDP. But from now on, the discloser must “reference the fact that the disclosing party is subject to a CIA” and “send a copy of the disclosure to the disclosing party’s OIG monitor.” The new SDP also clarifies that any disclosure that constitutes a “reportable event” under the CIA must be reported to OIG.

5. Interface between OIG & Department of Justice (DOJ)

Previous SDP: OIG stated that it would coordinate with the DOJ and “advocate that the disclosing parties receive a benefit from disclosure under the SDP” in both civil and criminal matters.

Revised SDP: OIG states that it will still advocate for a benefit in civil matters, but removes the same language with respect to criminal matters. OIG also notes that it will refer any disclosure of criminal conduct via the SDP to DOJ for resolution.

Bottom Line: Don’t expect expect OIG to “help with” DOJ in criminal matters, regardless of how cooperative your lab is with the agency under the SDP.

6. Online Submission Required

The previous version of the SDP allowed for disclosure online or via mail. But OIG has eliminated mail disclosure and is requiring all disclosure to be submitted electronically through the OIG web page.

Takeaway

You should automatically consider the SDP option any time you uncover what might turn out to be potential health care fraud at your lab. However, you need to adjust your pros and cons calculations to account for the new revisions. Among the changes, the one most likely to have a direct impact on the decision is the elimination of the expectation of OIG help with the DOJ on criminal matters. However, keep in mind that Sentencing Guidelines for criminal cases continue to award “credit” for compliance and disclosure efforts.

SELF-DISCLOSURE BY THE NUMBERS

In addition to announcing the rule changes, OIG provided updated historical statistics on the SDP process. Key numbers:

• +2,200: The number of disclosures OIG has resolved under the SDP between 1998 and 2020
• +$870 million: The amount recovered for federal health care programs as a result of those disclosures
• 330: The number of SDP cases OIG resolved through settlements resulting in the release of all disclosing parties from permissive exclusion without requiring any integrity measures between 2016 and 2020