DOJ and HHS Launch Health Care False Claims Act Self-Disclosure Pilot Program

Key Takeaways

• The US Department of Justice (DOJ) and Department of Health and Human Services (HHS) have launched a 6-month pilot program encouraging health care organizations to voluntarily disclose potential False Claims Act (FCA) violations.
• Eligible organizations may resolve disclosed misconduct through repayment of 1.25 to 1.6 times the base amount and receive certain civil liability protections.
• The program offers health care providers and payers a structured approach to addressing compliance violations, with submissions accepted through April 22, 2027.

The DOJ and HHS announced a 6-month pilot program on October 22, 2026, designed to encourage health care organizations to voluntarily disclose potential violations of the federal FCA in exchange for a defined financial settlement framework and coordinated civil liability protections.¹

The Healthcare False Claims Act Self-Disclosure Pilot Program (FCA SDPP), administered through the DOJ Civil Division in partnership with HHS, allows eligible organizations to resolve previously undisclosed misconduct through financial repayment and corrective action.¹

The initiative applies to health care providers, suppliers, manufacturers, payers, and other entities receiving federal health care program funds, directly or indirectly. For managed care organizations and other health care stakeholders, the program introduces a new pathway for addressing potential compliance violations while limiting certain civil and administrative enforcement risks.^1,2

How Does the False Claims Act Self-Disclosure Program Work?

Under the pilot program, eligible organizations may voluntarily report potential FCA violations that were previously unknown to the federal government.¹

Participating organizations must provide a detailed description of the potentially unlawful conduct, identify applicable legal requirements, and submit supporting documentation. They must also describe corrective actions taken to address the misconduct and prevent similar violations.^1,3

Companies are required to provide financial information sufficient to calculate repayment obligations and certify that their submissions are truthful and complete.¹

In exchange, participating organizations may receive a coordinated civil release covering the disclosed conduct under the federal FCA and certain HHS administrative authorities.^1,4

According to the DOJ, the program is intended to encourage voluntary compliance while allowing federal enforcement agencies to focus resources on organizations that do not proactively address potential misconduct.¹

Financial Repayment Requirements and Liability Protections

A central component of the pilot program is its defined repayment structure.

Organizations that qualify must repay between 1.25 and 1.6 times the base self-disclosure repayment amount, depending on several factors, including the following:

• The timeliness of the voluntary disclosure
• The duration and scope of the potential misconduct
• Whether senior leadership was involved
• The financial benefit received by the organization
• Whether the organization inherited the potential liability through a transaction and promptly addressed the issue^1,3

According to an analysis published by law firm Sidley Austin, the program also establishes specific considerations for potential FCA violations involving the Anti-Kickback Statute. Rather than automatically using the full value of associated claims to calculate repayment, federal officials may consider the remuneration involved, revenue generated, and the absence of aggravating circumstances, including patient harm.³

Participating organizations may also receive protections against certain administrative actions, including Medicare enrollment revocation and permissive exclusion. Under the program, the HHS Office of Inspector General will not require a Corporate Integrity Agreement, and the Centers for Medicare & Medicaid Services will not impose certain civil monetary penalties or pursue enrollment revocation for the disclosed conduct.^1,3

The pilot addresses civil liability and does not provide protection against potential criminal enforcement.^3,4

Implications for Managed Care Organizations and Health Care Compliance

The new self-disclosure framework may have implications for payers, managed care organizations, and other entities responsible for overseeing federal health care program spending.

By establishing a defined repayment range and coordinated resolution process, the program offers eligible organizations greater clarity regarding the potential financial consequences of voluntarily reporting compliance violations.^2,3

The initiative may also influence how health care organizations approach internal investigations, compliance monitoring, documentation, and corrective action when potential FCA violations are identified.

However, participation requires organizations to disclose relevant information, provide supporting records, and demonstrate steps taken to address the underlying conduct.^1,3

The DOJ and HHS will accept submissions through April 22, 2027. Late or incomplete submissions will not be reviewed.¹

The 6-month initiative represents a new approach to resolving certain potential federal health care fraud violations through voluntary disclosure, financial repayment, and coordinated regulatory oversight.

References

1. US Department of Justice. Justice Department's Civil Division and Department of Health and Human Services announce anti-fraud initiative. October 22, 2026. Accessed October 23, 2026. https://www.justice.gov/opa/pr/justice-departments-civil-division-and-department-health-human-services-announce-anti-fraud
2. Sheetz M. Feds launch False Claims Act self-disclosure pilot. Becker's Hospital Review. October 22, 2026. Accessed October 23, 2026. https://www.beckershospitalreview.com/legal-regulatory-issues/feds-launch-false-claims-act-self-disclosure-pilot/
3. Sidley Austin LLP. DOJ and HHS launch healthcare FCA self-disclosure pilot program with fixed repayment multiplier. FCA Blog. October 22, 2026. Accessed October 23, 2026. https://fcablog.sidley.com/2026/10/22/doj-and-hhs-launch-healthcare-fca-self-disclosure-pilot-program-with-fixed-repayment-multiplier/
4. Seiden D. DOJ starts self-disclosure program for potential false claims. Bloomberg Law. October 23, 2026. Accessed October 23, 2026. https://news.bloomberglaw.com/business-and-practice/doj-starts-self-disclosure-program-for-potential-false-claims