Elizabeth J. "Betsy" McCubrey

Partner

Elizabeth J. "Betsy" McCubrey is a partner in Morgan Lewis's FDA and Healthcare Practice. Ms. McCubrey focuses her practice on fraud and abuse investigations, healthcare regulatory compliance, and clinical research. She provides guidance to a wide variety of healthcare organizations, including medical device manufacturers, pharmaceutical manufacturers, retail pharmaceutical and optical establishments, hospitals, academic medical centers, suppliers, hospices, dialysis providers, and research institutions.

Ms. McCubrey has assisted clients with the following:

• Investigations, audits, and informal inquiries undertaken by federal and state regulatory and enforcement agencies, including the U.S. Department of Justice, the U.S. Department of Health & Human Services (HHS) Office of Inspector General and HHS’s Centers for Medicare & Medicaid Services
• Internal investigations relating to potential violations of federal and state fraud and abuse laws, including false claims acts, antikickback and physician self-referral laws, and related criminal, civil, and administrative healthcare fraud and abuse laws
• Development, implementation, and monitoring of healthcare fraud and abuse and corporate compliance programs
• Physician employment, recruitment, and retention arrangements
• Reimbursement under Medicare, Medicaid, and other third-party reimbursement programs
• Compliance with state regulatory issues, including licensure requirements, corporate practice of medicine prohibitions, and change-in-ownership requirements, as well as fee-splitting, self-referral, and kickback prohibitions

Ms. McCubrey is a Certified IRB Professional (CIP) through the Applied Research Ethics National Association (ARENA), and counsels clients on a range of clinical research and Institutional Review Board (IRB) issues. She has drafted and revised human subject research policies, including policies and procedures relating to IRBs generally, IRB member and principal investigator conflicts of interest, and the informed consent process; counseled providers on the application of the Medicare National Coverage Decision relating to services furnished in the context of clinical trials; assisted providers in connection with regulatory audits undertaken by FDA and OHRP; and drafted and negotiated clinical trial agreements with sponsors and CROs.

Prior to joining Morgan Lewis, Ms. McCubrey was a partner at an international law firm, focusing on the healthcare industry.

Ms. McCubrey received her J.D. from the University of North Carolina School of Law in 2001. She received her M.P.H. in health policy and administration from the University of North Carolina in 2000 and her B.A., magna cum laude and Phi Beta Kappa, in sociology from Wake Forest University in 1997.

Ms. McCubrey is admitted to practice in the District of Columbia and Georgia.