The U.S. Department of Justice (“DOJ”) Civil Division and the U.S. Department of Health and Human Services (“HHS”) recently announced a new Healthcare False Claims Act Self-Disclosure Pilot Program (“Pilot Program”). The Pilot Program offers healthcare organizations a defined path to resolve potential civil False Claims Act (“FCA”) violations by voluntarily disclosing them in exchange for a coordinated civil release and a capped repayment.
The Pilot Program is available to a broad range of healthcare organizations, including providers, suppliers, manufacturers, payors, and related entities whose items or services are paid for, directly or indirectly, by HHS federal healthcare programs. To qualify, an organization must, by April 22, 2027, voluntarily disclose a potential FCA violation that was previously unknown to the federal government.
To participate in the Pilot Program, an organization must submit a complete disclosure that includes: (1) a detailed description of the conduct potentially violating the FCA, including relevant facts and circumstances; (2) documents sufficient to fully reflect the nature and operation of the conduct; (3) a description of remedial and corrective measures taken to address the identified conduct; (4) financial information sufficient for DOJ to calculate the required repayment amount; and (5) a certification by an authorized representative and the designation of a point of contact.
The Pilot Program offers several significant incentives for participating healthcare organizations.
- Reduced Repayment. Participating organizations may resolve potential FCA violations by paying between 1.25 and 1.6 times the applicable base repayment amount, rather than facing the FCA’s statutory treble damages and per-claim penalties. For self-disclosures made outside the Pilot Program, DOJ has typically sought multipliers of approximately 1.8 to 2.0 times the applicable base repayment amount.
- Coordinated Release. Participating organizations may receive a coordinated release of liability under the FCA and certain HHS administrative authorities. As part of the resolution, the HHS Office of Inspector General will not require a Corporate Integrity Agreement (“CIA”) to resolve its permissive exclusion authority and the Centers for Medicare & Medicaid Services (“CMS”) will not revoke Medicare enrollment or billing privileges or impose civil monetary penalties for the disclosed conduct. These protections remove substantial operational, financial, compliance, and reputational burdens that would otherwise accompany exclusion, a CIA, or CMS enforcement action.
Healthcare organizations should carefully evaluate potential FCA violations identified through internal audits, compliance reviews, or other reporting mechanisms to determine whether voluntary disclosure under the Pilot Program may be appropriate. The Pilot Program is temporary, and disclosures must be submitted by April 22, 2027. Organizations considering participation should begin evaluating possible disclosures promptly to ensure sufficient time to investigate the conduct, calculate potential repayment obligations, and prepare the required documentation.
Thompson Coburn’s healthcare and government enforcement attorneys regularly counsel healthcare organizations on FCA matters, internal investigations, and voluntary self-disclosures to federal agencies. For assistance evaluating potential FCA exposure, determining eligibility for the Pilot Program, or preparing a timely and complete disclosure, please contact our team.
