DOJ and HHS Launch Healthcare False Claims Act Self-Disclosure Pilot Program Promising Favorable Terms

On October 22, 2026, the Department of Justice (DOJ) Civil Division and the Department of Health and Human Services (HHS) announced a six-month Healthcare False Claims Act Self-Disclosure Pilot Program (FCA SDPP or the “Program”), which offers health care companies a pathway to resolve potential civil liability under the False Claims Act (FCA), 31 U.S.C. § 3729 et seq., by self-disclosing conduct previously unknown to the government. In exchange for complete disclosure, remediation, and a repayment of 1.25 to 1.6 times a calculated base amount, disclosing companies receive a coordinated civil release from DOJ and HHS—with no factual admissions and no Corporate Integrity Agreement (CIA). In FCA cases based on alleged kickbacks, the value of the kickback can serve as the base amount, potentially offering steep discounts off traditional FCA damages, which DOJ typically bases on the total claims paid. The Program is open through April 22, 2027, providing companies a compressed window to make a challenging strategic assessment.

Overview of the Program

The FCA SDPP is a joint effort of the DOJ Civil Division and several HHS components—the Office of the General Counsel, the Office of Inspector General (HHS-OIG), and the Centers for Medicare & Medicaid Services (CMS). Beyond an FCA release, the Program also addresses certain HHS administrative authorities, including Medicare enrollment revocation (42 C.F.R. § 424.535) and permissive exclusion (42 C.F.R. §§ 1001.901, 1001.951). DOJ framed the Program as a means to resolve past misconduct quickly and to “prioritize the government’s resources toward recalcitrant actors.”

Eligibility is broad: providers, suppliers, manufacturers, payors, and related entities that furnish, bill for, or are otherwise paid for items or services by federal health care programs may participate. The critical limitation is that the disclosed conduct must be previously unknown to the federal government. A company whose conduct is already known may still seek cooperation credit under Justice Manual § 4-4.112, but is not eligible for a Program resolution. The Program is civil only; potential criminal conduct must be disclosed to DOJ’s National Fraud Enforcement Division under its separate coordination policy with HHS-OIG.

A qualifying submission must, among other requirements: (1) describe all relevant details of the potential FCA violations, including the specific requirements violated and the time period; (2) append as exhibits documents sufficient to fully reflect the conduct, with the narrative cross-referencing those exhibits; (3) describe remedial measures taken; (4) provide financial information sufficient for DOJ to calculate a “Base Self-Disclosure Repayment;”¹ and (5) include a certification from an authorized representative that the submission is truthful and complete. Submissions are due by 11:59 PM on April 22, 2027, and late or partial submissions will not be accepted or reviewed.

The repayment multiplier (1.25–1.6) will turn on the timeliness of the disclosure, the duration and scope of the misconduct, senior leadership involvement, the financial benefit to the company, and whether the company has successor liability but promptly remediated. Notably, for Anti-Kickback Statute (AKS) violations, the government will forgo damages based on claim-paid amounts and instead calculate the base repayment by reference to the remuneration, the revenue derived from the conduct, and the absence of aggravating factors such as patient harm.

Key Considerations

Disclosure Decisions Continue to be Complex and Fact-Dependent

 Whether to self-disclose remains one of the most consequential judgment calls a company can make. The Program applies only to conduct the government does not already know about, and the submission must be complete and certified by a company representative—once made, the disclosure cannot be walked back. Companies will need to assess the strength of the potential liability, the likelihood that the conduct will surface, the scope of the conduct across business lines, and potential criminal exposure that falls outside the Program entirely. Companies should also consider how a disclosure may interact with qui tam litigation that may already be pending and with obligations to other regulators.

Avoidance of Double and Treble Damages

The FCA ordinarily exposes defendants to treble damages (plus per-claim penalties). Negotiated settlements often include double damages. The Program instead caps repayment at 1.25 to 1.6 times the base amount, a meaningful discount relative to litigated or negotiated FCA outcomes. Because timeliness is an express factor in setting the multiplier, the financial benefit is likely to be greatest for companies that move quickly after identifying an issue. The AKS damages methodology described above may further reduce exposure in kickback matters, where the amount the government allegedly paid for false claims often far exceeds the amount of the alleged kickbacks.

No Corporate Integrity Agreement

Resolutions involving DOJ and HHS have traditionally carried the risk of a CIA—a multi-year compliance undertaking with HHS-OIG that often imposes independent review, reporting, and certification obligations. Under the Program, HHS-OIG “shall not require a Corporate Integrity Agreement” as part of resolving its exclusion authorities, and CMS will not impose civil monetary penalties or seek revocation. For many organizations, avoiding the cost and operational burden of a CIA may be as valuable as the monetary savings. Disclosing parties also need not make separate disclosures of the same conduct through the HHS-OIG Self-Disclosure Protocol or the CMS Self-Referral Disclosure Protocol.

Compressed Timeline

The benefits come with a compressed schedule. A disclosing company must investigate the conduct, quantify its financial impact (for example, through sampling and extrapolation), assemble exhibits sufficient to fully reflect the conduct, prepare a narrative that cross-references those exhibits, implement and document remediation, and secure a certification—all before the April 22, 2027 deadline. At the same time, companies are effectively racing the government and potential relators: if the conduct becomes known to the government first, the Program is no longer available.

What Companies Should Do Now

Companies in the health care sector should promptly evaluate any open compliance matters, hotline reports, or audit findings that could implicate the FCA and determine whether they may be candidates for the Program. Acquirers should consider the Program in post-closing diligence, as the Program expressly contemplates successor-liability scenarios. Of course, companies should also closely consult with counsel to weigh the potential risks and benefits of any potential disclosure.

For more information about the Program and its implications, please reach out to your usual contact on the Ropes & Gray litigation and enforcement team.