AMY DELINE is counsel in the firm’s Healthcare practice. She represents pharmaceutical and device manufacturers, biotechnology companies, managed care organizations and other healthcare clients in fraud and abuse enforcement and litigation matters. She has defended numerous healthcare clients in criminal, civil and administrative matters brought by the Department of Justice, FDA, Department of Health and Human Services Office of Inspector General, U.S. Attorneys’ Offices and State Attorneys General. Amy has negotiated Corporate Integrity Agreements with the HHS-OIG and counseled clients on CIA implementation and related issues. Her work also includes representing clients in Congressional investigations, conducting confidential internal investigations and assisting clients with compliance audits.
Amy leverages her enforcement experience in counseling clients on issues such as Medicare and Medicaid coverage and reimbursement, fraud and abuse laws, HHS-OIG mandatory and permissive exclusion, managed care requirements and compliance program effectiveness.
Amy’s representative matters include:
- Securing a declination from DOJ and voluntary dismissal of the underlying qui tam complaint in a civil investigation concerning a biotechnology company’s alleged violations of the Anti-Kickback statute
- Representing a managed care organization in a False Claims Act investigation of its Medicare Advantage reimbursement and related practices
- Successfully appealing CMS’ denial of a managed care organization’s application to expand its Medicare Advantage network, including representing the organization in an administrative hearing
- Representing a biotechnology company in settlement and CIA negotiations with a U.S. Attorney’s Office and HHS-OIG concerning alleged violations of the Anti-Kickback statute
- Assisting a generic pharmaceutical manufacturer in a criminal investigation led by a U.S. Attorney’s Office and the FDA concerning its manufacturing practices and potential misbranding allegations
- Representing a medical device manufacturer in a Congressional investigation, and subsequent DOJ civil investigation, consumer litigation, and a related FOIA challenge in federal court
- United States ex rel. Brown v. Celgene Corp., defense of a pharmaceutical company in civil litigation pursued by a qui tam relator alleging off-label promotion and violations of the Anti-Kickback Statute
- United States ex rel. Lisitza v. Johnson & Johnson, defense of a pharmaceutical company in litigation against DOJ concerning alleged off-label promotion and violations of the Anti-Kickback Statute
Ms. DeLine graduated cum laude from the Northwestern University School of Law, where she was the Centennial Editor of the Journal of Criminal Law and Criminology. She has a Master’s in Social Work from Washington University in St. Louis. Ms. DeLine earned her B.A. in Sociology with distinction from the University of Michigan – Ann Arbor.