DOJ and HHS Launch False Claims Act Self-Disclosure Pilot Program for the Health Care Sector
A new six-month pilot program launched by the U.S. Department of Justice ("DOJ") and Department of Health and Human Services ("HHS") allows health care companies that self-disclose previously unknown potential violations of the False Claims Act ("FCA") to obtain a coordinated civil release with no factual admissions, no Corporate Integrity Agreement, and a repayment multiplier in the range of 1.25 to 1.6.
On October 22, 2026, DOJ and HHS launched a health care self-disclosure pilot program ("SDPP") that offers companies a coordinated resolution of civil liability under the FCA (31 U.S.C. § 3729 et seq.) and HHS's revocation and exclusion authorities. The SDPP pertains only to civil conduct; potential criminal conduct must be disclosed to DOJ's National Fraud Enforcement Division.
The SDPP covers only entities paid directly or indirectly by HHS federal health care programs that disclose potential FCA violations "previously unknown to the federal government." Disclosures concerning already-known conduct, while ineligible under this program, may still receive cooperation credit under DOJ's Justice Manual § 4-4.112.
Self-disclosures under the SDPP must be submitted to the email address FCA‑SDPP@usdoj.gov by 11:59 p.m. on April 22, 2027, and must:
- Describe potentially violative conduct, including the laws, regulations, or other requirements violated, and the conduct's duration;
- Include supporting documents;
- Detail the corrective action or actions taken;
- Provide financial information sufficient to calculate a "Base Self-Disclosure Repayment";
- Certify that the submission is truthful and complete; and
- Identify a point of contact.
Under the SDPP, participants will receive a coordinated civil release from DOJ and HHS, with no factual admissions. HHS Office of the Inspector General will not require a Corporate Integrity Agreement as part of any resolution, and the Centers for Medicare & Medicaid Services will not impose civil monetary penalties or seek Medicare enrollment revocation. DOJ's Civil Division calculates the Base Self-Disclosure Repayment from financial information supplied by the company. The SDPP states that repayment will be the Base Self-Disclosure Repayment multiplied by 1.25–1.6, a range depending on several factors: the timeliness of the disclosure, the duration and scope of the misconduct, senior leadership involvement, financial benefits received, and prompt remediation of conduct inherited through successor liability.
For Anti-Kickback Statute violations, the SDPP states that the government will, for purposes of the program only, forgo damages based on claims-paid amounts and instead calculate the Base Self-Disclosure Repayment by considering the amount of remuneration, the revenue derived from the disclosed conduct, and the absence of aggravating factors such as patient harm.
The SDPP provides a path to resolve civil exposure on predictable terms and to avoid costly relator-driven litigation. Before the SDPP's deadline of April 22, 2027, health care entities should analyze open internal investigations and potential noncompliance to assess whether disclosure under this program, among other self-disclosure options, is warranted.
