Research Hospital Agrees to Nearly $20M Settlement Relating to Self-Disclosed Clinical Trial Misconduct
Florida-based non-profit cancer treatment and research center H. Lee Moffitt (Moffitt) agreed to pay $19,564,743 to resolve its self-disclosure related to improper claims for patient care items and services provided during research studies.
Moffitt’s self-disclosed conduct included its submission to Medicare and other federal health care programs non-reimbursable claims in violation of Centers for Medicare and Medicaid Services (CMS) clinical research trial rules. The claims—for items and services provided in the course of clinical trial research—should have been billed to non-government trial sponsors rather than to government health care programs. The improper claims were made over the course of several years, from 2014 to 2020.
Moffitt became aware of these issues independent of government action and, to its credit, initiated an independent investigation and compliance review. The review culminated in a written disclosure to the federal government.
The settlement highlights two persistent themes in federal enforcement. First, the government’s emphasis on combating fraud, false claims, waste and abuse in the healthcare space, including where health care and research overlap. Second, the benefits of voluntary self-disclosure of false or fraudulent activity related to federal funding—including funding under grants, cooperative agreements, and contracts—made possible through robust internal reporting channels, prompt internal investigation, and a culture of compliance. Voluntary disclosure can result in significantly reduced penalties and damages. Although $19.5 million is no small sum, the total represents approximately 1.5 times the government’s full damages. Without cooperation, the total could have been significantly higher—up to 3 times the total damages, plus statutory penalties under the False Claims Act’s damages provisions.
The U.S. Department of Justice’s press release is available here.
If you have any questions regarding False Claims Act investigations, please contact Rosie Dawn Griffin (rgriffin@feldesman.com) or Mindy B. Pava (mpava@feldesman.com) or call 202.466.8960.
