The 340B Drug Pricing Program and Recent False Claims Act Circuit Court Opinions

Rachel V. Rose | Rachel V. Rose – Attorney at Law, PLLC

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.

• Education & Credentials

Rachel holds a Juris Doctor from Stetson University College of Law, a Master of Business Administration with minors in healthcare and entrepreneurship from Vanderbilt University, and an Executive Certification in Leadership and Negotiation from Harvard Law School. This combination of legal, business, and leadership credentials reflects the multidisciplinary foundation of a practice that spans healthcare compliance, cybersecurity, securities law, and whistleblower representation. She is co-editor of the American Health Lawyers Association’s Enterprise Risk Management Handbook for Healthcare Entities (2nd Edition) and coauthor of two ABA publications — The ABCs of ACOs and What Are International HIPAA Considerations? — as well as contributing author to multiple legal and medical reference books.

• Recognition & Leadership

Rachel has received a remarkable breadth of professional recognition, including consecutive listing in the Texas Bar College, the National Women Trial Lawyers Association’s Top 25, Houstonia Magazine’s Top Lawyers in healthcare, the National Trial Lawyers Association’s Top 100, and SuperLawyers in healthcare. She has also been named 1st Healthcare Compliance’s Top Presenter in both 2019 and 2022. As an Affiliated Member of Baylor College of Medicine’s Center for Medical Ethics and Health Policy — where she teaches bioethics — she occupies a distinctive position at the intersection of law, medicine, and ethics. Her Capitol Hill experience during HIPAA’s passage and her HHS tenure during HITECH implementation reflect an early and sustained engagement with the legislative foundations of healthcare privacy law that few practitioners can match.

• Professional Involvement

Rachel is extensively published, a sought-after conference presenter, and a frequently quoted expert on cybersecurity, healthcare compliance, and whistleblower law. She serves as co-editor of the AHLA’s Enterprise Risk Management Handbook for Healthcare Entities and has co-authored books for the American Bar Association on ACOs and international HIPAA considerations, as well as contributing chapters to legal and medical reference works. She teaches bioethics at Baylor College of Medicine’s Center for Medical Ethics and Health Policy, bridging legal and clinical perspectives for healthcare professionals. Her work conducting HIPAA Risk Analyses for domestic and international organizations and representing clients in government enforcement matters reflects active engagement with the compliance challenges healthcare and technology organizations face in an evolving regulatory landscape.

• Experience

Rachel Rose’s career is defined by a rare combination of legislative, regulatory, and private practice experience that spans more than two decades at the intersection of healthcare, cybersecurity, and the law. She was present at two defining moments in U.S. healthcare privacy law — working on Capitol Hill when HIPAA was enacted in 1996 and at HHS when the HITECH Act was being implemented in 2009 — and has built a practice that applies that institutional knowledge to transactional, compliance, and litigation matters for domestic and international clients. Her work includes HIPAA Risk Analyses, government enforcement representation, securities and whistleblower matters, and cybersecurity compliance counseling. Her ABA and AHLA publications, her bioethics teaching at Baylor College of Medicine, her Harvard Executive Certification, and her consecutive national and regional recognition across legal, trial, and compliance communities reflect a career of exceptional depth, versatility, and sustained professional impact.

SESSION 1 – Workings of the 340B Program | 12:30pm – 12:55pm

Participants 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.

SESSION 2 – Notable 340B Program District Court Cases & the Pilot Program | 12:55pm – 1:05pm

This 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.

SESSION 3 – Sheldon (4th Circuit) | 1:05pm – 1:15pm

Attorneys 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.

SESSION 4 – Adventist Health (9th Circuit) | 1:15pm – 1:25pm

This 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.

SESSION 5 – Conclusion | 1:25pm – 1:30pm

Participants 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.