Key Takeaways
- • On October 22, 2026, DOJ's Civil Division and HHS announced the six-month Healthcare False Claims Act Self-Disclosure Pilot Program (FCA SDPP), offering health care companies a route to quickly resolve past FCA misconduct.
- • Resolutions carry a repayment multiplier of 1.25 to 1.6 times the "Base Self-Disclosure Repayment," and provide releases of HHS-OIG permissive exclusion authorities and CMS revocation authority, with no civil monetary penalties and no Corporate Integrity Agreement.
- • The program covers only conduct previously unknown to the government; a sealed qui tam complaint could render a disclosure ineligible after submission.
- • Submissions are due by 11:59 p.m. on April 22, 2027, and no timeline for government review or resolution is set.
- • Criminal conduct is excluded and must go to DOJ's National Fraud Enforcement Division (NFED), which is also the destination for disclosures that may be referred from the civil program.
Summary
The U.S. Department of Justice (DOJ) Civil Division and the U.S. Department of Health and Human Services (HHS) on October 22, 2026, announced the Healthcare False Claims Act Self-Disclosure Pilot Program (FCA SDPP), a six-month program offering health care companies a "way to quickly resolve past misconduct by self-disclosing potential violations" of the False Claims Act (FCA). The protocol promises a "coordinated resolution" of civil FCA liability and certain HHS administrative authorities. The program covers FCA violations relating to HHS-funded federal health care programs and is limited to "legitimate American healthcare businesses," according to the announcement. Potential criminal conduct is excluded and must be disclosed to DOJ's NFED.
Eligibility is narrow. The program covers only conduct previously unknown to the government. Matters already known remain eligible for credit under DOJ's longstanding policies in Justice Manual Section 4-4.112, which are less transparent and offer less certainty. A sealed qui tam complaint, of which a company may be unaware, could render a disclosure ineligible. The announcement does not address conduct implicating both HHS and non-HHS programs such as TRICARE, VA health care or FEHBP, and offers no assurances on state treatment of Medicaid or CHIP disclosures. The policy's references to "companies" and "entities" leave open whether individual practitioners may participate.
Submissions require six categories of information, including a conduct description, supporting exhibits, remedial measures, financial data sufficient for damages calculation, an authorized representative's certification, and point-of-contact details. Filings go to a dedicated mailbox and are due by 11:59 p.m. on April 22, 2027; late or partial submissions will not be reviewed. The program does not assure that disclosed information will not be shared with NFED, other DOJ or HHS components, other law enforcement, or relators.
The program offers a multiplier of 1.25 to 1.6 times the Base Self-Disclosure Repayment, varying with factors such as timeliness, duration and scope of misconduct, senior leadership involvement, and financial benefit. Participants receive a release covering HHS-OIG permissive exclusion authorities and CMS revocation authority, though the announcement does not address whether CMS will release its concurrent permissive exclusion authority delegated on October 14, 2026. Resolutions carry no civil monetary penalties and no Corporate Integrity Agreement, a departure from the HHS-OIG Self-Disclosure Protocol. Resolutions require no factual admissions. Review timing is unspecified, and recent health care self-disclosures have taken multiple years to settle.
The two damages examples leave key questions open. The sampling example references "a sample chart review" and extrapolation without methodology. The Anti-Kickback Statute example says the government will forgo "damages based on the claim-paid amounts," but retains discretion over remuneration and revenue, making the program most advantageous where liability substantially exceeds revenue, such as bundled-payment devices and buy-and-bill products. The pilot also follows an October 15, 2026, joint NFED and HHS-OIG announcement, and arrived two days after NFED launched the Fraud Whistleblower Incentive Program, which pays $10,000 to $30,000 for information leading to criminal charges. Counsel should weigh the risk of ineligibility after submission and of disclosures being used in litigation or referred to other agencies.
Eligibility is narrow. The program covers only conduct previously unknown to the government. Matters already known remain eligible for credit under DOJ's longstanding policies in Justice Manual Section 4-4.112, which are less transparent and offer less certainty. A sealed qui tam complaint, of which a company may be unaware, could render a disclosure ineligible. The announcement does not address conduct implicating both HHS and non-HHS programs such as TRICARE, VA health care or FEHBP, and offers no assurances on state treatment of Medicaid or CHIP disclosures. The policy's references to "companies" and "entities" leave open whether individual practitioners may participate.
Submissions require six categories of information, including a conduct description, supporting exhibits, remedial measures, financial data sufficient for damages calculation, an authorized representative's certification, and point-of-contact details. Filings go to a dedicated mailbox and are due by 11:59 p.m. on April 22, 2027; late or partial submissions will not be reviewed. The program does not assure that disclosed information will not be shared with NFED, other DOJ or HHS components, other law enforcement, or relators.
The program offers a multiplier of 1.25 to 1.6 times the Base Self-Disclosure Repayment, varying with factors such as timeliness, duration and scope of misconduct, senior leadership involvement, and financial benefit. Participants receive a release covering HHS-OIG permissive exclusion authorities and CMS revocation authority, though the announcement does not address whether CMS will release its concurrent permissive exclusion authority delegated on October 14, 2026. Resolutions carry no civil monetary penalties and no Corporate Integrity Agreement, a departure from the HHS-OIG Self-Disclosure Protocol. Resolutions require no factual admissions. Review timing is unspecified, and recent health care self-disclosures have taken multiple years to settle.
The two damages examples leave key questions open. The sampling example references "a sample chart review" and extrapolation without methodology. The Anti-Kickback Statute example says the government will forgo "damages based on the claim-paid amounts," but retains discretion over remuneration and revenue, making the program most advantageous where liability substantially exceeds revenue, such as bundled-payment devices and buy-and-bill products. The pilot also follows an October 15, 2026, joint NFED and HHS-OIG announcement, and arrived two days after NFED launched the Fraud Whistleblower Incentive Program, which pays $10,000 to $30,000 for information leading to criminal charges. Counsel should weigh the risk of ineligibility after submission and of disclosures being used in litigation or referred to other agencies.
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