DOJ and HHS Launch New Healthcare False Claims Act Self-Disclosure Pilot Program

The U.S. Department of Justice (DOJ) Civil Division and U.S. Department of Health and Human Services (HHS) on October 22, 2026, announced a six-month Healthcare False Claims Act Self-Disclosure Pilot Program (SDPP). The SDPP will close on April 22, 2027, with no review of late or incomplete submissions.

Under the SDPP, healthcare companies that voluntarily disclose potential False Claims Act (FCA) violations may obtain a release from civil FCA liability, as well as from liability under certain HHS administrative authorities.

To participate in the SDPP, a healthcare entity must:

• describe all relevant details of conduct that may have violated the FCA
• produce documents showing the full nature, terms and operation of the disclosed conduct
• describe remedial action taken by the entity
• make a financial repayment

As with all self-disclosures, the devil is in the details. Providing sufficient information for the government to evaluate the robustness of a company's disclosure and stated resolution will help ensure effective and efficient disposition of the disclosure.

Reduced Damages Multiplier

Notably, repayment will be subject to a damages multiplier lower than the one prescribed by the FCA. The FCA provides for per-claim civil penalties and treble damages (a multiplier of three), whereas the SDPP repayment multiplier will range from 1.25 to 1.6. Although FCA settlements commonly reduce the multiplier, they rarely reduce it to the levels offered under the SDPP, making the program a potentially significant reduction in financial exposure.

According to DOJ, the multiplier will depend on several factors, including the timeliness of the disclosure, duration and scope of the conduct, involvement of senior leadership, financial benefit to the disclosing entity and whether an entity facing successor liability promptly remediated.

The SDPP applies only to civil liability. Self-disclosure of potential criminal conduct is handled by DOJ's National Fraud Enforcement Division and governed by the HHS Office of Inspector General Policy on Coordination of Voluntary Self-Disclosure in Health Care Fraud Matters. Under a memorandum from U.S. Assistant Attorney General Colin McDonald, the National Fraud Enforcement Division is prioritizing voluntary self-disclosure and healthcare fraud cases, and the SDPP reinforces those priorities.

Key Takeaways

• The Participation Window Is Short: The SDPP closes on April 22, 2027. Companies already evaluating potential FCA exposure should promptly assess whether participation is in their interest.
• Participation Requires Complete, Well-Prepared Disclosures: Deciding whether to self-disclose is a significant strategic decision with lasting consequences. The SDPP's requirements are strict, and DOJ will not consider incomplete submissions. Companies weighing a submission should carefully evaluate the potential benefits and risks with experienced FCA and healthcare counsel before proceeding.

Holland & Knight's False Claims Act Defense and Healthcare teams regularly counsel clients on self-disclosure decisions and related government investigations. For more information or questions, please contact the authors.

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