DOJ and HHS Launch Pilot for Healthcare False Claims Self-Disclosure
DOJ and HHS announce a pilot for healthcare providers to self-disclose FCA violations.
Why it matters: This pilot signals a shift toward proactive compliance in healthcare, reducing litigation risks and encouraging transparency. Legal and healthcare counsel must prepare to navigate this new framework to mitigate potential liabilities effectively.
- The pilot program runs from October 22, 2026, to April 22, 2027.
- Healthcare companies can voluntarily disclose potential FCA civil violations unknown to the government.
- Repayments will be between 1.25 and 1.6 times the base amount, influenced by disclosure timing and misconduct scope.
- Self-disclosing entities receive a coordinated civil release, avoiding exclusions, corporate integrity agreements, and billing revocations.
On October 22, 2026, the U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) Civil Division announced a six-month pilot program for healthcare providers. This Healthcare False Claims Act Self-Disclosure Pilot Program (FCA SDPP) invites healthcare companies to voluntarily disclose potential civil violations of the federal False Claims Act (FCA) that are previously unknown to the government.
Participants must submit complete and timely disclosures—including specific details about the laws violated, the duration of the misconduct, and supporting evidence. They must also outline remedial actions to prevent recurrence. Financial penalties are calculated using a multiplier range of 1.25 to 1.6 times the base amount. Factors such as the timeliness of the disclosure, the misconduct’s scope, senior leadership involvement, and the financial benefit to the company influence the multiplier.
In exchange, companies receive a coordinated civil release from FCA liability and certain HHS administrative authorities without needing to make factual admissions. The HHS Office of Inspector General will not impose exclusions or require a Corporate Integrity Agreement, and CMS will maintain the provider’s billing privileges.
Assistant Attorney General Brett A. Shumate emphasized that "voluntary self-disclosure is a powerful indicator of a company's commitment to compliance and accountability," allowing DOJ to focus on deliberate fraud. Similarly, Deputy Assistant Attorney General Brenna Jenny highlighted that the program offers "predictable and clear incentives for self-disclosure" and recognizes companies that remediate and compensate promptly.
HHS Inspector General T. March Bell noted the program’s role in advancing "transparency, accountability, and compliance," giving organizations a clear pathway to self-disclose and protect taxpayer funds without harsh penalties like Corporate Integrity Agreements.
Submissions must be made electronically by April 22, 2027. Late or incomplete submissions will not be considered. This pilot could transform enforcement strategy by encouraging early detection and resolution of FCA concerns in healthcare.
By the numbers:
- 6 months — duration of the pilot program (Oct 22, 2026 to Apr 22, 2027)
- 1.25 to 1.6 times — multiplier range for financial repayments based on misconduct factors
Yes, but: The criteria for determining the exact multiplier within the 1.25 to 1.6 range are not specified, and the program does not clarify procedures for disclosures that involve potential criminal violations alongside civil ones.
What's next: Healthcare entities have until April 22, 2027, to submit disclosures under this pilot program.