Program Details
2026-05-01 12:30:00
Over 1,000+ webinars
Course Overview
2026-05-01 12:30:00
1h CLE Credits
Intermediate
1
12:30 pm - 12:55 pm ESTParticipants will examine the foundational mechanics of the 340B Program, including covered entity eligibility, manufacturer obligations, ceiling price requirements, contract pharmacy arrangements, and the compliance conditions that govern every aspect of program participation.
Rachel V. Rose 12:55 pm - 1:05 pm ESTThis segment reviews landmark district court decisions that have shaped 340B enforcement, alongside a focused analysis of HRSA’s Rebate Model Pilot Program and its compliance and operational implications for covered entities and manufacturers.
Rachel V. Rose 1:05 pm - 1:15 pm ESTAttorneys will analyze the Fourth Circuit’s ruling in Sheldon, examining how the court addressed manufacturer obligations and covered entity rights, and what the decision means for advising healthcare clients operating within the 340B Program.
Rachel V. Rose 1:15 pm - 1:25 pm ESTThis section examines the Ninth Circuit’s decision in Adventist Health, focusing on the court’s interpretation of 340B pricing requirements, contract pharmacy access disputes, and the strategic implications for healthcare attorneys navigating manufacturer restrictions in Western jurisdictions.
Rachel V. Rose 1:25 pm - 1:30 pm ESTParticipants will consolidate key takeaways from the program, connecting statutory fundamentals, district court precedent, and appellate rulings into a practical framework attorneys can immediately apply when advising safety-net healthcare clients on 340B compliance.
Rachel V. RoseRachel V. Rose, JD, MBA is a Houston-based attorney and consultant whose practice spans transactional, compliance, and litigation matters in cybersecurity, healthcare, securities, and Dodd-Frank and False Claims Act whistleblower claims. Her background is distinctively multidisciplinary — she worked on Capitol Hill when HIPAA was enacted in 1996 and at HHS during the implementation of the HITECH Act in 2009, giving her firsthand legislative and regulatory insight that few practitioners can claim. She holds a law degree from Stetson University College of Law, an MBA with minors in healthcare and entrepreneurship from Vanderbilt University, and an Executive Certification in Leadership and Negotiation from Harvard Law School. She is an extensively published author, a sought-after speaker, a recognized expert in healthcare compliance and cybersecurity law, and an Affiliated Member at Baylor College of Medicine’s Center for Medical Ethics and Health Policy, where she teaches bioethics.
Rachel V. Rose, JD, MBA is a Houston-based attorney and consultant whose practice spans transactional, compliance, and litigation matters in cybersecurity, healthcare, securities, and Dodd-Frank and False Claims Act whistleblower claims. Her background is distinctively multidisciplinary — she worked on Capitol Hill when HIPAA was enacted in 1996 and at HHS during the implementation of the HITECH Act in 2009, giving her firsthand legislative and regulatory insight that few practitioners can claim. She holds a law degree from Stetson University College of Law, an MBA with minors in healthcare and entrepreneurship from Vanderbilt University, and an Executive Certification in Leadership and Negotiation from Harvard Law School. She is an extensively published author, a sought-after speaker, a recognized expert in healthcare compliance and cybersecurity law, and an Affiliated Member at Baylor College of Medicine’s Center for Medical Ethics and Health Policy, where she teaches bioethics.
Requirements
The Alabama State Bar MCLE Commission requires attorneys to complete 12 credits, including 1 ethics, by December 31 of each year. All credits must be reported by February 15 of the following year. A maximum of 12 credits, including 1 ethics credit, may be carried over for 1 year only.
Formats
