Moffitt Cancer Center’s recent $19.5 million settlement with the U.S. Department of Justice (DOJ) and the state of Florida resolving allegations that billing errors violated the False Claims Act (FCA) triggered a “fully redesigned” billing program but “did not affect the finances” of the Tampa, Fla., institution, Moffitt officials told RRC.

But, the cancer center was otherwise unwilling to answer questions or share experiences that might benefit others, even while acknowledging in a statement to RRC that clinical trial billing rules are “complex.” Moffitt’s settlement joins the fairly rare group of research universities and other institutions that have faced government enforcement action related to billing issues of this type. More commonly, FCA and other grant fraud cases have centered on misspending, effort reporting errors, research misconduct and undisclosed foreign or other support. Like Moffitt’s new settlement, some involve self-disclosure, but others result from whistleblower complaints.

DOJ’s Jan. 4 announcement included the 15-page settlement itself, although more than half of the pages contain boilerplate legal language and not many specifics about the case—which was concluded through 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 the HHS Office of Inspector General, the government said.^[1]

The full settlement amount is $19,564,743. Of this total, $13,043,162 is restitution and $6,521,581 is a penalty—50% of the restitution amount. Under the FCA, DOJ can impose penalties up to triple the government’s loss.

At issue were “improper claims submitted to federal healthcare programs for certain patient care items and services provided during research studies that were not eligible for reimbursement,” DOJ said. The government “acknowledged that Moffitt took a number of significant steps entitling it to credit for cooperating with the government.”