For the first time since 2013, The U.S. Department of Health & Human Services Office of Inspector General has issued updates to its Healthcare Fraud Self-Disclosure Protocol. Created in 1998, the protocol can be used to create a process to voluntarily identify, disclose and resolve instances of potential fraud involving federal healthcare programs.

The OIG noted that between 1998 and 2020, it resolved more than 2,200 disclosures resulting in recoveries of more than $870 million.

The following are some takeaways:

  • For kickback-related submissions accepted into the SDP, OIG will require a minimum $100,000 settlement amount up from $50,000 to resolve the matter. For all other matters accepted into the SDP, OIG will require a minimum of $20,000 settlement amount to resolve the matter, up from $10,000.
  • Mailed submissions are no longer accepted. All submissions must be made through the HHS-OIG website.
  • Added references to OIG’s Grant and Contract Self-Disclosure Protocols.
  • Clarified that those under a Corporate Integrity Agreement (CIA) may disclosed reported events using the SDP and specified that the disclosing party must reference the CIA and send a copy of the DSP disclosure to its monitor.
  • Clarified that the Department of Justice sometimes settles SDP cases.
  • Clarified that disclosers must include damages to each affected federal healthcare program and the sum of all damages.
  • Made technical changes to statistics, terminology and background facts.

What did not change?

  • Timelines and content requirements
  • Methods for calculation of damages
  • Timely settlement with a lower multiplier and an exclusion release.

OIG notes that healthcare providers have an obligation to take steps to detect and prevent fraudulent activities. This can be done as a result of voluntary self-assessment or in response to external forces.

There are benefits to self-disclosure including settlements that can result in OIG deciding not to exclude a provider from federal healthcare programs. Between 2016 and 2020, OIG resolved 330 SDP cases through settlements.

OIG believes those who use the SDP and cooperate during an investigation deserve to pay a lower multiplier on single damages than would normally be required in resolving a government-initiated investigation. Each case would be determined individually.

The SDP is not limited. All providers, suppliers or other persons subject to OIG’s Civil Monetary Penalty authorities are eligible to use the SDP. Disclosing parties subject to investigations, audits or other oversight activities are not automatically precluded from using the SDP. However, the disclosure must be in good faith and not an attempt to circumvent an ongoing investigation.

The SDP can prove to be a valuable tool for any healthcare entity. The Health Law Offices of Anthony C. Vitale has extensive experience representing clients in voluntary disclosures, audits and overpayments and can represent your interests through all stages of the disclosure and refund process in an effort to achieve the most successful results.

Contact The Health Law Offices of Anthony C. Vitale at 305 358-4500 or