Billing federal healthcare programs for ineligible clinical trial-related items over a six-year span has landed a Tampa, Fla., cancer research hospital in hot water with the government, but the nonprofit site has reached a $19.5 million settlement after admitting responsibility for the billing issues, working with the government and taking action on its own.

Between 2014 and 2020, the nonprofit site, H. Lee Moffitt Cancer Center & Research Institute, billed Medicare and other federal healthcare programs for services not covered under the Centers for Medicare and Medicaid Services’ (CMS) rules for trial reimbursement, rather than billing them to sponsors as they should have, according to the Department of Justice (DOJ), which announced the settlement.

But when these problems, described in the settlement document as “issues with … billing systems and practices,” came to light, Moffitt proactively launched a third-party investigation and compliance assessment and delivered a written disclosure of its findings to the government. It then cooperated fully with the ensuing federal investigation and quickly took significant corrective actions, the DOJ said.

These actions included:

• Creating a new unit within its finance department to ensure billing compliance for clinical trials
• Updating policies and procedures related to billing of clinical trial services
• Hiring additional staff to carry out the new policies and procedures
• Pausing all charges associated with clinical trials until it could confirm the new policies and procedures were effective

In total, H. Lee Moffitt Cancer Center & Research Institute will pay approximately $18.2 million to the federal government and $1.3 million to Florida Medicaid.

“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,” Brian Boynton, principal deputy assistant attorney general and head of the DOJ’s Civil Division, said.

“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,” added U.S. Attorney for the Middle District of Florida Roger Handberg.

The False Claims Act, the federal government’s main tool for pursuing fraud against the government, can fine sites up to three times the loss to Medicare or Medicaid plus $11,000 for each false or fraudulent claim filed, meaning fines can quickly add up to millions of dollars.

Read the settlement document here.