Holly C. Barker counsels clients on US federal and state healthcare fraud and abuse enforcement and regulatory matters, primarily defending companies in False Claims Act (FCA) actions. Holly represents pharmaceutical and medical device manufacturers, hospital systems, long–term care facilities, clinical laboratories, physicians, and senior healthcare executives in complex criminal, civil and administrative fraud and abuse matters before US Attorneys’ Offices, the HHS Office of Inspector General, and state MFCUs.
Holly also handles Medicare claims disputes in administrative proceedings. Her cases typically involve alleged violations of the Anti-Kickback Statute, the FCA, the Federal Food Drug and Cosmetic Act, and the Stark law.
When not litigating, Holly counsels companies on compliance program development related to off-label reprint distribution, evaluation and management (E&M) coding, reimbursement support services, lab specimen handling and tracking, joint ventures, and reporting and returning of overpayments.
In addition to her FCA defense work, Holly assists clients in structuring financial relationships to comply with regulatory requirements. She performs regulatory due diligence prior to acquisitions, joint ventures, and mergers. Holly also has experience counseling pharmaceutical manufacturers and nonprofit foundations in structuring prescription drug patient assistance programs.
Prior to joining Morgan Lewis, Holly was an associate at an international law firm, where she handled healthcare fraud and abuse matters.
American University, Washington College of Law, 2009, J.D., Cum Laude
Wheaton College, 2004, B.A.
District of Columbia
Awards and Affiliations
Named, Modern Healthcare ’s “Largest Healthcare Firm” (2016–2017)
Ranked, Washington DC Super Lawyers "Rising Star" (2016)
Vice Chair-Elect, Life Sciences, ABA’s Health Law Section (2016–2017 Bar Year)
Member, Health Law Section, American Bar Association