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HHS, DOJ pilot self-disclosure program for False Claims Act violations

News RoomBy News RoomOctober 26, 2026Updated:October 26, 20268 Mins Read
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For six months, the federal government is offering health care companies something rare: a structured chance to confess to potential fraud, repay what they owe, and avoid the kind of crushing penalties that can destroy a business. The Department of Health and Human Services and the Justice Department’s Civil Division recently announced the Healthcare False Claims Act Self-Disclosure Pilot Program, a voluntary initiative aimed at companies that suspect they may have violated the federal False Claims Act. In plain terms, the False Claims Act is the government’s main legal weapon against those who bilk Medicare, Medicaid, and other federally funded health care programs. Normally, when the government suspects fraud, it can investigate, sue, and demand triple damages plus steep per-claim penalties—a combination that has put many health care companies out of business. This pilot program offers an alternative route: come forward first, cooperate fully, and resolve the matter through a coordinated civil release from liability, allowing a company to move forward without the existential threat of a federal lawsuit. The program is a joint effort, with HHS and DOJ working together to evaluate disclosures, calculate repayments, and provide a single, predictable path toward closure. Submissions are being accepted electronically at [email protected] until April 22, 2027, and the agencies have made clear that late or incomplete disclosures will not be considered.

But participating in this pilot is not simply an invitation to admit wrongdoing and receive a hug. The requirements are serious, and they demand real transparency. A company that wants to participate must disclose all relevant details about the potential violations, which means providing the government with a complete account of what happened, how it happened, and who was involved. This is not the time for vague descriptions or carefully worded apologies; the government expects documents that show the full nature and operation of the conduct, including internal records, billing data, emails, and any other evidence that paints a comprehensive picture. Companies also have to describe the remedial steps they have taken since discovering the problem. That could mean disciplining or firing responsible employees, strengthening compliance programs, hiring outside auditors, or instituting new internal controls to prevent similar problems in the future. On top of that, the company must repay the government according to a detailed formula. The repayment multiplier ranges from 1.25 to 1.6 times the amount of the overpayment or alleged loss, depending on several factors. The government will look at how quickly the company came forward after discovering the misconduct, how long the misconduct lasted and how widespread it was, whether senior leadership was involved, how much the company financially benefited from the fraudulent conduct, and whether the company inherited liability through a merger or acquisition but promptly remediated the problem. The multiplier is meant to encourage timely and complete cooperation: the faster and more thorough a company is, the lower its financial exposure will be.

So what does a company get in return? Quite a lot, if you consider the alternative. After a successful resolution through the pilot, DOJ will provide a release for the disclosed potential False Claims Act violations, meaning the company will not face a civil lawsuit from the federal government for those specific acts. The HHS Office of Inspector General will agree not to impose an exclusion from federal health care programs, which is critical because exclusion means a provider cannot bill Medicare, Medicaid, or other government-funded programs—effectively a death sentence for many practices and suppliers. The OIG will also not require a Corporate Integrity Agreement, a type of intense federal oversight that can last years and often requires costly outside monitoring and detailed compliance reporting. In addition, the Centers for Medicare & Medicaid Services will not revoke the provider’s or supplier’s enrollment and billing privileges, and neither CMS nor the OIG will impose civil monetary penalties. In other words, companies can correct their mistakes, pay back what they owe, and continue serving patients and participating in government health care programs. The arrangement is designed to be a clean settlement: no bans, no monitors, no extra penalties beyond the repayment. For many organizations, this is an extraordinarily favorable outcome compared to the potential consequences of a False Claims Act lawsuit, which can include treble damages, penalties of thousands of dollars per claim, and years of litigation uncertainty.

The public rationale for the program, as expressed by the officials involved, is centered on protecting taxpayer dollars while encouraging accountability. HHS Secretary Robert F. Kennedy Jr. framed the effort in blunt terms, saying that every dollar stolen from health care programs is a dollar taken from taxpayers and patients. He thanked President Trump for making the fight against fraud, waste, and abuse a priority, and he described the pilot as a clear path for companies to come forward, repay what they owe, and correct misconduct while the government aggressively pursues those who defraud the American people. That dual message—compassion for voluntary cooperators, relentless enforcement against deliberate fraudsters—is central to the program’s design. HHS Inspector General T. March Bell echoed that sentiment, emphasizing that transparency, accountability, and compliance are essential to safeguarding the integrity of federal health care programs. Bell noted that the pilot gives companies a clear pathway to self-disclose potential misconduct and resolve issues without a Corporate Integrity Agreement. By encouraging organizations to come forward, address compliance concerns, and undertake meaningful remediation, the program promotes proactive accountability that helps protect taxpayer dollars and beneficiaries. Both officials framed the initiative not as a lenient loophole, but as a smart enforcement tool that rewards honesty and focuses government resources on companies that refuse to play by the rules.

There are important nuances and strategic considerations that any eligible company should understand before jumping in. First, this pilot is for civil violations of the False Claims Act, not criminal conduct. It does not provide immunity from criminal prosecution, nor does it resolve potential violations of other federal laws, state laws, or private whistleblower suits brought under the False Claims Act’s qui tam provisions. A company that suspects criminal activity is still exposed, and the program should not be viewed as a blanket amnesty. Second, the government is explicit that submissions must be complete and timely. A company that rushes to submit a partial disclosure without fully investigating the scope of the problem risks being rejected, and once rejected, it may lose the opportunity to participate altogether. Incomplete disclosures could also invite more aggressive government scrutiny, making a bad situation worse. Third, the program is open to health care companies generally, including providers, suppliers, and other entities that bill federal health care programs. The reference to CMS enrollment and billing privileges indicates that the program is particularly relevant to hospitals, physician practices, clinics, pharmacies, and durable medical equipment suppliers, but any company doing business with federal health care dollars should pay attention. Fourth, the calculation of the repayment multiplier is intentionally subjective. The factors listed—timeliness, duration, scope, leadership involvement, financial benefit, and successor liability—give the government wide discretion. A company that discovered fraud years ago and did nothing may face a significantly higher multiplier than a company that self-reported within weeks of discovering an isolated billing error. Companies should also understand that the six-month window is real, and that the program’s end date is not arbitrary. Missing the deadline means returning to the old world of uncertain self-disclosure processes and potentially much harsher outcomes.

In a broader sense, this pilot program represents a shift in how the federal government approaches health care fraud enforcement. Instead of relying solely on the hammer of litigation, audits, and penalties, the government is now offering an olive branch to companies that are willing to self-police. The message is subtle but powerful: if you find a problem, fix it, tell us, and pay us back, and we will let you continue serving patients. That approach could encourage more health care companies to invest in internal compliance monitoring and to act quickly when something looks wrong, knowing there is a predictable path forward. It also responds to a long-standing complaint from the health care industry that the False Claims Act is too punitive and that minor billing errors are treated like intentional fraud. Under the pilot, companies that make honest mistakes and promptly correct them can escape the most devastating consequences. Of course, skeptics might argue that the program lets bad actors off too easily, especially if a company conceals misconduct for years and then cleverly discloses it to avoid a lawsuit. But the government has attempted to address that concern by linking the repayment multiplier to the seriousness of the conduct and the speed of disclosure. A company that deliberately defrauds Medicare for a decade, with active executives involved, will pay far more than the base amount and might not be accepted into the program at all. What the pilot does, in essence, is create a sliding scale of consequences for a sliding scale of culpability. It is an experiment in calibrated enforcement, one that could reshape the relationship between health care companies and the government if it succeeds. For any organization with a possible false claims issue, the advice is straightforward: consult experienced legal counsel promptly, conduct a thorough internal investigation, and determine whether this limited window is worth taking. The program signals that the government is serious about recovering stolen funds, but it is also serious about rewarding those who choose integrity. The deadline is set, the pathway is open, and the choice now sits with the health care industry.

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