The Florida-based H. Lee Moffitt Cancer Center & Research Institute Hospital agreed to pay nearly $20 million as part of a settlement with the Department of Justice (DOJ) addressing alleged violations of the False Claims Act for improperly billing federal healthcare programs.

The DOJ said in a press release Thursday that Moffitt received credit for cooperating with the agency’s investigation, including self-disclosing its alleged misconduct and remediating the issues.

The settlement total includes approximately $18.2 million, of which about $12.2 million is restitution, to be paid to the government and more than $1.3 million to be paid to the state of Florida.

The details: Between May 2014 and May 2020, Moffitt submitted claims to Medicare, Medicaid, and TRICARE for clinical trial services that were not reimbursable under Centers for Medicare and Medicaid Services rules, according to the DOJ. The items and services provided should have been billed to trial sponsors or provided free of charge, the agency contended.

Compliance considerations: Upon discovery of the apparent issues, Moffitt “initiated an independent investigation and compliance review and voluntarily provided the government with a written disclosure of its findings,” the DOJ said. The cancer center disclosed relevant documents and information relating to the case and retained an independent expert to assist in determining the amounts billed to federal healthcare programs.

Remedial efforts Moffitt took, per the settlement, included:

  • 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.

“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,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the DOJ’s Civil Division, in its release.

The settlement did not include a determination of liability.

Company response: “Moffitt Cancer Center discovered several years ago it had incorrectly billed Medicare and other federal healthcare programs for costs associated with clinical research,” it said in an emailed statement. “We quickly worked with the federal government to ensure substantial remedial measures were taken to avoid this from happening moving forward.”