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

WASHINGTON – The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice’s Civil Division have launched a six-month Healthcare False Claims Act Self-Disclosure Pilot Program for health care companies that voluntarily disclose potential civil violations of the federal False Claims Act.

Companies that meet the pilot’s requirements can resolve disclosed conduct through a coordinated civil release from liability under the federal False Claims Act and certain HHS administrative authorities.

“Every dollar stolen from our health care programs is a dollar taken from taxpayers and patients,” said HHS Secretary Robert F. Kennedy, Jr. “I thank President Trump for making the fight against fraud, waste, and abuse a priority. HHS and DOJ are giving companies a clear path to come forward, repay what they owe, and correct misconduct – while aggressively pursuing those who defraud the American people.”

To participate, companies must:

• Disclose all relevant details about the potential violations
• Provide documents showing the full nature and operation of the conduct
• Describe the remedial steps they have taken
• Make a repayment calculated under the protocol, which applies a multiplier of 1.25 to 1.6. (The multiplier will vary based on factors such as 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 for the misconduct but promptly remediated.)

In exchange, companies will receive:

• A release from DOJ for the disclosed potential False Claims Act violations
• The HHS Office of Inspector General (OIG) will not impose an exclusion or require a Corporate Integrity Agreement as part of the resolution
• CMS will not revoke the provider’s or supplier’s enrollment and billing privileges, and neither CMS nor OIG will impose civil monetary penalties.

“Transparency, accountability, and compliance are critical to safeguarding the integrity of federal health care programs,” said HHS Inspector General T. March Bell. “This pilot program provides companies with 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 protects taxpayer dollars and beneficiaries.”

Companies may submit disclosures electronically to FCA-SDPP@usdoj.gov through April 22, 2027. Late or incomplete submissions will not be reviewed.

Related reading:

• CMS adds 11 medical supply companies to Preclusion List.
• CMS suspends more than 100 DME suppliers in fraud crackdown.