Tampa-based research hospital settles self-disclosed False Claim Act allegations over billing for clinical trial costs

by Ben Vernia | January 7th, 2024

On January 4, the Department of Justice announced that the University of South Florida’s H. Lee Moffitt Cancer Center & Research Institute had agreed to settle self-disclosed allegations that the hospital improperly billed for costs associated with the care of patients participating in clinical trials. According to DOJ’s press release:

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.

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