H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. (Moffitt), a non-profit cancer treatment and research center based in Tampa, Florida, has agreed to pay $19,564,743 to resolve its civil liability under the False Claims Act for improper claims submitted to federal healthcare programs for certain patient care items and services provided during research studies that were not eligible for reimbursement. In connection with the settlement, the United States acknowledged that Moffitt took a number of significant steps entitling it to credit for cooperating with the government.
This settlement resolves Moffitt’s civil liability for claims that it submitted to Medicare and other federal healthcare programs during the period from 2014 to 2020 for services that were not reimbursable under Centers for Medicare and Medicaid Services rules governing reimbursement for clinical care provided in connection with clinical research trials. Specifically, Moffitt billed federal healthcare programs for items and services provided as part of clinical trial research that should have been billed to non-government trial sponsors. After learning of these issues, Moffitt initiated an independent investigation and compliance review and voluntarily provided the government with a written disclosure of its findings. Moffitt cooperated fully with the government’s investigation of the conduct and implemented prompt and substantial remedial measures. The federal share of the settlement is approximately $18.2 million and the state Medicaid share of the settlement is approximately $1.3 million.
“Healthcare providers participating in federal healthcare programs must ensure that they comply with applicable rules and regulations, including those relating to the submission of claims in connection with clinical research,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “As today’s settlement reflects, when providers run afoul of their obligations, they can mitigate the consequences by making timely self-disclosures, cooperating with investigations and taking appropriate remedial measures.”
“Protecting the nation’s healthcare programs is a top priority of our office,” said U.S. Attorney Roger B. Handberg for the Middle District of Florida. “When those who receive funds from government healthcare programs discover that they have submitted improper claims, we encourage them to promptly disclose the issues and cooperate fully with investigators to reach an appropriate and swift settlement. That’s what Moffitt did here: self-reported its improper claims, cooperated with government investigators and took action to remediate its billing systems.”
“Providers participating in clinical trials funded by federal health care programs must abide by specific guidelines that safeguard these programs,” said Acting Special Agent in Charge Fernando Porras of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “Providers will be held accountable if they bill for services outside the rules governing reimbursement. Together, with our law enforcement partners, we will continue to maintain the fiscal integrity of federal healthcare programs.”
The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, the U.S. Attorney’s Office for the Middle District of Florida and HHS-OIG.
The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to HHS at 800-HHS-TIPS (800-447-8477).
The matter was handled by Trial Attorney Gary Dyal of the Civil Division’s Commercial Litigation Branch, Fraud Section and Assistant U.S. Attorneys Randy Harwell and Carolyn Tapie for the Middle District of Florida.
The claims resolved by the settlement are allegations only and there has been no determination of liability.
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