On November 8, 2021, the U.S. Department of Health & Human Services Office of Inspector General (“OIG”) revised its Self-Disclosure Protocol (“SDP”) for health care providers for the first time since 2013. OIG’s revisions brought the SDP in line with the current statutory penalties under the Anti-Kickback Statute (“AKS”) and Civil Monetary Penalties Law (“CMPL”) and made other important updates. Providers who self-disclose potential violations through the SDP can expect these and other changes, described below, to affect the resolution of their disclosures.
Background
The SDP is a means for health care providers to resolve potential liability under the AKS and CMPL as well as reduce the likelihood of False Claims Act investigations or whistleblower suits. The OIG also has the authority to resolve self-disclosures relating to physician financial arrangements that implicate both the AKS and Stark Law. The SDP is also available to resolve other matters subject to OIG’s purview, including false billing and the employment of, or contracting with, excluded persons. In the Background section of the revised SDP, the OIG explains that none of the 330 self-disclosures resolved between 2016 and 2020 required a Corporate Integrity Agreement (“CIA”) as part of the settlement. The OIG also discusses its streamlined process in which the average time for resolution is less than twelve months following acceptance of a self-disclosure into the SDP. These could be considered some encouraging words for providers contemplating the benefits of a SDP submission. Besides renaming the SDP to the “Health Care Fraud” SDP, we discuss some of the other notable updates below.
2021 Updates
Increased Minimum Penalties. OIG’s revised SDP doubles the minimum stipulated penalty for AKS issues from $50,000 to $100,000, which brings the minimum penalty in line with the statutory maximum penalty for a single violation under the AKS. OIG also doubled the minimum penalty for all other issues arising under the CMPL to $20,000. This increase is consistent with statutory increases in minimum civil monetary penalties for violations of the False Claims Act.
More Granular Damages Requirements. OIG updated the SDP to require a self-disclosing provider to calculate the damages incurred by each of the federal health care programs. While this requirement was often expected by the OIG staff attorneys in charge of self-disclosures, it was not stated within the SDP document.
Requirements for Providers with CIAs. OIG clarified the SDP for providers that are currently under CIAs. Previously, this topic was not addressed within the SDP, and providers may have faced a dilemma if they discovered a potentially disclosable issue: Could they secure a release by disclosing the issue through the SDP, or did the CIA prohibit them from doing so? The updated SDP allows providers under a CIA to self-disclose conduct through the SDP, and when they do so, they must send a copy of the disclosure to the OIG monitor assigned to them under their CIA. If the disclosed issue rises to the level of a Reportable Event under the CIA, the disclosure must state this fact.
Submission Only Through the OIG’s Website. The OIG now requires that the SDP be submitted only through the OIG’s website and may no longer be submitted by U.S. mail. The link to the SDP online submission form can be found here.
SDP Not Fit for All Issues. Over the last several years, OIG has created alternative disclosure protocols for issues arising under federal contracts and federal grants. OIG updated the SDP to recognize these new protocols. Providers that are federal grantees or federal contractors who identify potential misconduct that could be reportable to OIG may need to carefully consider which disclosure protocol is appropriate for their situation.
Practical Takeaways
Health care providers have come to regard the SDP as an important regulatory compliance risk mitigation tool, and it continues to be one even taking into account OIG’s updates. Providers who identify potential noncompliance with the AKS (including physician arrangements also implicating Stark) or CMPL should consider whether self-disclosure is an appropriate method of mitigating their risk, including the potential to avoid a CIA or higher damage totals if they become a target of a federal investigation related to the same matter. For providers who do elect to proceed with an SDP submission, they should expect that OIG will demand at least the minimum penalties stated in the updated SDP ($100,000 for AKS violations and $20,000 for other violations).
In addition, the requirement that providers calculate the damages for each federal health care program will give providers reason to engage in a rigorous analysis of their disclosed issues to ensure they secure a release from liability to any of the federal health care programs.
Providers who have identified instances of potential non-compliance should contact their legal counsel to discuss the risks and benefits of disclosing particular conduct through the SDP.
For more information on this topic, please contact:
- Scott Taebel at (414) 721-0445 or staebel@wp.hallrender.com;
- Katherine Kuchan at (414) 721-0479 or kkuchan@wp.hallrender.com;
- James Junger at (414) 721-0922 or jjunger@wp.hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
