The DoJ said that H. Lee Moffitt Cancer Center & Research Institute Hospital will pay $19 million to settle the charges and that the hospital received credit for cooperating with the agency’s investigation, including self-disclosing its alleged misconduct, remediating the issues, and upgrading compliance measures around billing.

This settlement resolves Moffitt’s 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 legally reimbursable. 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 began its own investigation and compliance review and voluntarily provided the government with a written disclosure of its discoveries. Moffitt cooperated fully with the government’s investigation of the conduct and implemented quick and significant corrective measures.

Improved Compliance Measures

According to the settlement, Moffit took the following steps to correct the issues with its billing system:

• Establishing a new unit within its finance department responsible for ensuring compliant billing of services provided in clinical trials;
• Updating its policies and procedures relating to the billing of services provided in clinical trials;
• Hiring additional staff to implement these new policies and procedures; and
• Placing a blanket hold on all charges associated with clinical trials until it could ensure the new policies and procedures were working effectively.

“Healthcare providers participating in federal healthcare programs must ensure that they comply with applicable rules and regulations, including those relating to the submission of claims in connection with clinical research,” said Attorney General Brian Boynton, 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.”

Roger Handberg, an attorney for the Middle District of Florida, stresses how crucial it is to protect the nation’s healthcare programs. He highlights the encouragement for those receiving funds from government healthcare to quickly disclose and cooperate when they find improper claims. “Protecting the nation’s healthcare programs is a top priority of our office,” said Handberg. “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. That’s what Moffitt did here: self-reported its improper claims, cooperated with government investigators and took action to remediate its billing systems.”

“Providers participating in clinical trials funded by federal health care programs must abide by specific guidelines that safeguard these programs,” said Special Agent Fernando Porras of the Department of Health and Human Services Office of Inspector General. “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.”  

Jacob Horowitz is a contributing editor at Compliance Chief 360°

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