On November 8, 2021, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) updated and renamed the Provider Self-Disclosure Protocol, which established a process for individuals to voluntarily disclose potential fraud involving federal health care programs.  The OIG’s Provider Self-Disclosure Protocol is now the Health Care Fraud Self-Disclosure Protocol (“SDP”).  

The SDP includes an increase to the minimum settlement amounts to align with legislative adjustments to penalty amounts and clarifications to requirements and procedures.  The SDP also includes guidance on investigating conduct, quantifying potential damages, and the method of reporting the conduct to OIG.  According to the OIG, using the SDP has several benefits, including (1) a “presumption against requiring integrity agreement obligations in exchange for a release of OIG’s permissive exclusion authorities in resolving an SDP matter;” (2) paying a lower multiplier on single damages; and (3) mitigation of potential exposure to liability under the Civil Monetary Penalties Law and the False Claims Act, as CMS agreed to suspend the obligation to report overpayments upon OIG acknowledgment of receipt of a timely SDP submission. 

In the SDP, the OIG clarified that any person or entity subject to the OIG’s civil monetary penalty authorities (at 42 C.F.R. Part 1003) is eligible to use the SDP, including health care providers and suppliers.  The SDP may be used for matters that potentially violate federal criminal, civil, or administrative laws where civil monetary penalties may be levied, including violations of the federal Anti-Kickback Statute (“AKS”), employing or contracting with individuals on the OIG’s exclusion list, and violation of the physician self-referral law (“Stark law”).

The SDP also includes clarifications regarding matters for which SDP is inappropriate or unavailable.  For example, the SDP is not available for acts exclusively involving overpayments.  The SDP is not available to disclose an arrangement that involves only potential liability under the Stark Law without accompanying potential liability under the AKS for the same arrangement.  If the conduct only involves the Stark law, then disclosure can be made through CMS’ Self-referral Disclosure Protocol.  The SDP is also not available to disclose improper acts associated with an HHS grant or contract.  Disclosures related to grants can be made through the OIG’s Grant Self-Disclosure Program.  And disclosures related to contracts can be made through the OIG’s Contractor Self-Disclosure Program.  

The SDP also clarifies requirements where the reporting entity is under a Corporate Integrity Agreement.  The SDP now notes that while disclosing parties are not precluded from using the SDP while under a Corporate Integrity Agreement, the “disclosure must reference the fact that the disclosing party is subject to a [Corporate Integrity Agreement].” A copy of the disclosure must also be provided to the disclosing party’s OIG monitor.  Also, reportable events (as defined by the corporate integrity agreement) must be disclosed a reportable event to the OIG, as required by the corporate integrity agreement.  The SDP maintains the requirement that disclosing parties “explicitly identify the laws that were potentially violated…”

There are three additional important updates to the SDP.  First, the OIG explained that it will not only coordinate with the U.S. Department of Justice in resolving SDP matters, but sometimes, the DOJ may participate in the settlement of SDP cases.  Where the DOJ participates in the settlement, “the matter will be resolved as DOJ determines is appropriate consistent with its resolution of [False Claims Act] cases …”  While the SDP indicates that the OIG will advocate that the disclosing party should receive a benefit from disclosure, the DOJ makes the ultimate determination where it is involved.   Second, while disclosers can provide an estimate of damages, under the updated SDP, the discloser “should identify the total estimated damages amount for each affected Federal health care program and the sum of estimated damages for all affected Federal health care programs.”  Finally, the minimum settle amounts increased in the updated SDP to match updated minimum penalty amounts.  For disclosures involving AKS violations, the minimum settlement amount is $100,000.  “For all other matters … [the] OIG will require a minimum $20,000 settlement amount to resolve the matter.”

Self-disclosure is a significant event that should be undertaken with careful consideration of the costs and benefits of such disclosure.  

The attorneys at Chilivis Grubman have vast experience representing healthcare providers of all types in connection with self-disclosures, Stark and Anti-Kickback compliance, health care fraud investigations, and various other regulatory matters.  If you need assistance with such a matter, please contact us today.