H. Lee Moffitt Cancer Center and Research Institute Hospital, a prominent nonprofit cancer treatment and research center based in Tampa, agreed to pay $19.6 million to resolve its civil liability in a case that involved billing for services outside federal rules governing reimbursement.
The agreement was announced in a Thursday statement from the U.S. Justice Department's Middle District of Florida office in Tampa.
Federal officials say improper claims were submitted to federal health care programs for certain patient care items and services provided during research studies that were not eligible for reimbursement.
In connection with the settlement, the Justice Department says it acknowledges that Moffitt took a number of significant steps "entitling it to credit for cooperating with the government." The settlement resolves Moffitt's civil liability for claims that it submitted to Medicare and other federal health care programs from 2014 to 2020.
Moffitt ran afoul of rules of the Centers for Medicare and Medicaid Services — rules governing reimbursement for clinical care provided in connection with clinical research trials, the Justice Department says. Specifically, Moffitt billed federal health care 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, the Justice Department says, 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 Justice Department says.
The federal share of the settlement is approximately $18.2 million and the state Medicaid share of the settlement is approximately $1.3 million, according to the government.
"Health care providers participating in federal health care programs must ensure that they comply with applicable rules and regulations, including those relating to the submission of claims in connection with clinical research," says Brian M. Boynton, deputy assistant attorney general and 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."
The claims resolved by the settlement are allegations only, and there has been no determination of liability, the Justice Department says.