McDermott Will & EmeryยทHEALTHCARE

DOJ, HHS Launch Six-Month Healthcare FCA Self-Disclosure Pilot

DOJ's Civil Division and HHS opened a six-month pilot on Oct. 22, 2026 giving healthcare entities a new channel to self-disclose potential False Claims Act liability.

On October 22, 2026, DOJ's Civil Division and HHS announced a six-month Healthcare False Claims Act Self-Disclosure Pilot Program (FCA SDPP), as reported by McDermott Will & Emery.

The significance is programmatic rather than doctrinal. The pilot creates a time-limited, government-run channel for healthcare entities that identify their own potential False Claims Act exposure to report it under self-disclosure protocols. Under the general FCA framework, qualifying self-disclosures typically permit mitigation of available damages and penalties relative to what a government-initiated investigation or FCA case would produce; the pilot appears designed to make that route more accessible to the sector.

For major-firm clients, the value is a new decision point on the compliance timeline: when a provider, health plan, or life-sciences company spots billing, coding, reimbursement, or overpayment issues internally, counsel will want to test whether the pilot's scope and eligibility match the client's facts before choosing among self-disclosure, corporate integrity agreement negotiation, or no action. Next steps: obtain the full terms, map them against open internal compliance matters, and watch for implementing guidance, designated participating agencies, and how the pilot interacts with existing self-disclosure authority and the anti-kickback and Stark analyses underlying many healthcare FCA matters. Reporting is truncated, so eligibility criteria remain unconfirmed.

false-claims-acthealthcare-complianceself-disclosuredoj-hhspilot-programfraud-and-abuse
Read the original firm alert โ†’ Wednesday, October 28, 2026

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