The H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. (Moffitt) recently agreed to pay $19,564,743 to resolve civil liability under the False Claims Act for submitting improper claims to federal health care programs for patient care items and services provided during research studies that were not eligible for reimbursement.
According to the Department of Justice (DOJ), from May 11, 2014, to May 10, 2020, Moffitt submitted claims to Medicare and other federal health care programs for services that were not reimbursable under Centers for Medicare and Medicaid Services (CMS) rules governing reimbursement for clinical care provided in connection with clinical research trials, including items and services that should have been billed to non-government trial sponsors.
In reaching the settlement amount, the United States acknowledged that Moffitt took significant steps in cooperating with the government’s investigation, including initiating an independent investigation and compliance review and providing the government with a written disclosure of its findings. Moffitt also fully cooperated with the investigation and implemented “prompt and substantial remedial measures.” In fact, the settlement notes that “On December 11, 2020, Moffitt disclosed to the United States that issues with its billing systems and practices had resulted in Moffitt billing federal health care programs for services provided during certain clinical research studies for which Moffitt should not have received payment.”
Some of the changes Moffitt made to remediate the issues with its billing systems and practices included: (1) establishing a new unit within its finance department responsible for ensuring compliant billing of services provided in clinical trials; (2) updating its policies and procedures relating to the billing of services provided in clinical trials; (3) hiring additional staff to implement new policies and procedures; and (4) placing a blanket hold on all charges associated with clinical trials until it could ensure that the new policies and procedures were working effectively.
The settlement also notes that because of Moffitt’s self-disclosure and changes made to its practices, the Department of Health and Human Services Office of Inspector General (HHS OIG) would “release and refrain from instituting, directing, or maintaining any administrative action seeking exclusion from Medicare, Medicaid, and other Federal health care programs” for the Covered Conduct.
Statements Regarding the Settlement
“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 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.”
Moffit noted that once it discovered the incorrect billing, it “quickly worked with the federal government to ensure substantial remedial measures were taken to avoid this from happening moving forward. Federal government billing standards driving what can be billed to federal programs (such as Medicare) are highly complex, and compliance with these billing standards requires continuous and concerted vigilance. Moffitt has fully redesigned its clinical research billing compliance programs to ensure adherence with all applicable federal government billing standards. Clinical research programs are a critical part of advancing cancer care. Moffitt’s clinical research programs continue to be safe and effective, and this did not affect the finances or quality of care provided to patients at Moffitt.”