Regina Myers, CHC, CHRC, is an attorney with King & Spalding's Healthcare Practice Group in Atlanta, GA. Ms. Myers' practice focuses on the Healthcare Industry and Pharmaceutical/Biotechnology/Medical Devices Industry. Ms. Myers is a member of the firm’s False Claims Act Working Group and Healthcare Reform Task Force, focusing on Compliance and Enforcement Improvements. Ms. Myers is Certified in Healthcare Compliance and Certified in Healthcare Research Compliance.
Healthcare Regulatory Compliance
Ms. Myers advises clients regarding healthcare laws relating to Medicare fraud and abuse, which includes the Anti-Kickback Statute (AKS), Stark, and the False Claims Act (FCA). Ms. Myers represents a wide variety of clients, including pharmaceutical and medical device manufacturers, pharmacy benefit managers, hospitals, managed care organizations, disease management companies, home healthcare providers, nursing homes and a retail pharmacy chain. This experience includes investigations by the Department of Justice, the Department of Health and Human Services - Office of Inspector General (HHS OIG), and the Securities and Exchange Commission, as well as whistleblower qui tam lawsuits. In addition, Ms. Myers has assisted with an investigation and its related self-disclosure to the HHS OIG of possible violations of federal healthcare laws, and the submission of a request to the HHS OIG for an Advisory Opinion.
Ms. Myers’ experience includes reviewing and revising corporate compliance programs to meet the U.S. Sentencing Guidelines for an effective compliance program. Ms. Myers also assists with transactional matters, focusing on due diligence examinations of target healthcare companies’ compliance history relating to AKS, Stark, FCA, Foreign Corrupt Practices Act, Health Insurance Portability and Accountability Act (HIPAA), Deficit Reduction Act, and other healthcare-related laws. In addition, Ms. Myers handles a variety of health law matters for our clients, including HMO application preparation and submission.
Pharmaceutical Product Liability Litigation
Ms. Myers is a member of the legal team that serves as national trial counsel for GlaxoSmithKline (GSK) in the defense of the blockbuster psychotropic medicine Paxil®. From 2003 to 2008, Ms. Myers’ experience included: defending GSK in lawsuits throughout the country, defending GSK in a suit brought by the New York Attorney General, representing GSK regarding FDA and various international regulatory matters, and representing GSK during a Senatorial inquiry and Congressional investigations. Ms. Myers’ involvement focused on the pediatric/adolescent population, which was a very high profile and high-stakes issue. Her primary responsibility was assisting in the preparation for depositions of top level GSK executives, consultants, principal investigators and expert witnesses, covering a wide range of FDA processes: clinical trials, new drug application submissions, labeling, and sales and marketing with an emphasis on off-label promotion.
Prior to joining King & Spalding in 2003, Ms. Myers’ health law experience included: state licensure of mental health programs and facilities; Joint Commission accreditation process; professional licensing, credentialing and privileging; and HIPAA and other federal privacy laws related to mental health medical records. Mental health has become a subspecialty of interest for Ms. Myers due to her experience as Compliance Manager for mental health residential programs, defending matters regarding a psychotropic drug, assisting with the firm’s pro bono project for Veterans with post-traumatic stress disorder, and coauthoring a report titled Justice for People with Mental Illness in Georgia: A Report on Conversations with Leaders in the Field.
Memberships
- State Bar of Georgia
- American Health Lawyers Association
Vice Chair, Conflicts of Interest and Transparency Affinity Group
Teaching Hospitals and Academic Medical Centers Practice Group
- Health Care Compliance Association
- Georgia Academy of Healthcare Attorneys
- Center for Law, Health & Society - Graduate Health Law Network
Georgia State University College of Law
