Healthcare Fraud Self-Disclosure Protocol Revised by OIG

On November 8, 2021, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an update to the Health Care Fraud Self-Disclosure Protocol (SDP). This revision, which is the first since 2013, incorporates legal changes made to the SDP.

The SDP was initially released in 1998, and can be used by healthcare providers, suppliers, or other individuals or entities subject to Civil Monetary Penalties to voluntarily disclose self-discovered evidence of potential fraud. Self-disclosure gives providers the opportunity to avoid the costs and disruptions associated with a government-directed investigation and civil or administrative litigation.

The 2021 SDP updates include the following changes:

  • Increased the minimum amounts required to settle under the SDP to match new statutory minimum penalty amounts.
  • Required SDP submissions to be made through HHS-OIG’s website.
  • Added reference to OIG’s 2019 Grant and Contract Self-Disclosure Protocols.
  • Clarified that Central Intelligence Agency (CIA) Reportable Events can be disclosed under the SDP.
  • Clarified that Department of Justice (DOJ) sometimes settles SDP cases.
  • Clarified that disclosures must include damages to each affected Federal healthcare program and the sum of all changes.
  • Made technical changes to statistics, terminology, and background facts.

The 2021 SDP updates do NOT change the following:

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

All submissions to the SDP must be made using HHS-OIG online submission page. The Self-Disclosure Online Submission page can be accessed at Health Care Fraud Self-Disclosure Protocol (hhs.gov).

The November 8, 2021, Updated OIG’s Health Care Fraud Self-Disclosure Protocol can be accessed at Self Disclosure Protocol 2021 (hhs.gov).

Issue:

An effective compliance and ethics program can reduce the risk of fraud, waste and abuse of government funds and prevent and detect criminal, civil, and administrative violations while promoting quality of care. Discovery of fraud, waste, or abuse of government funds should be immediately investigated, addressed, and, in collaboration with your compliance attorney, reported using the revised SDP protocols. Self-disclosure gives providers the opportunity to avoid the costs and disruptions associated with a government-directed investigation and civil or administrative litigation.

Discussion Points:

  • Review your policies and procedures for operating an effective Compliance and Ethics Program. Ensure that your policies are reviewed at least annually and updated when new information becomes available.
  • Train all staff on your compliance and ethics policies and procedures upon hire and at least annually. Document that these trainings occurred and file the signed document in each employee’s education file.
  • Periodically perform audits to ensure all staff are aware of compliance and ethics concerns and understand their responsibility to report any suspicion of compliance and ethics violations to their supervisor, the compliance and ethics officer, or via the anonymous hotline.