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

2026-05-01 12:30:00

1 hours

2026-05-01 12:30:00

1 Credits

Master the 340B Drug Pricing Program’s compliance requirements and dissect landmark Ninth and Fourth Circuit rulings to sharpen your healthcare regulatory practice.

2026-05-01 12:30:00

1 hours

Master the 340B Drug Pricing Program’s compliance requirements and dissect landmark Ninth and Fourth Circuit rulings to sharpen your healthcare regulatory practice.

2026-05-01 12:30:00

1 hours

1000+

Live stream programs

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Access to live webinars & recordings

70,000+

Trusted by Legal Professionals

1000+

Live stream programs

24/7

Access to live webinars & recordings

70,000+

Trusted by Legal Professionals

1000+

Live stream programs

24/7

Access to live webinars & recordings

70,000+

Trusted by Legal Professionals

1000+

Live stream programs

24/7

Access to live webinars & recordings

70,000+

Trusted by Legal Professionals

Key topics that will be covered

What will you learn

Attorneys will learn the key facets of the 340B Program and recent opinions from the U.S. Courts of Appeals for the Ninth and Fourth Circuits.

What will you gain

Attorneys will gain understanding of manufacturer obligations, covered entity eligibility, compliance conditions, and appellate court rulings affecting the 340B Program.

Medicaid Participation
Manufacturers in Medicaid must provide outpatient drugs to covered entities at reduced prices.
Upfront Discounts
Pharmaceutical manufacturers are required to provide up-front discounts under the 340B Program.
Outpatient Drugs
The 340B Program applies specifically to outpatient drug purchases by eligible entities.
Safety-Net Providers
Eligible safety-net hospitals and clinics receive significantly reduced pharmaceutical pricing.
Pilot Program
The program covers notable district court cases and the 340B Pilot Program.
Program Nuances
The 340B Program has many nuances and applications to different situations.

What will you learn

Attorneys will learn the key facets of the 340B Program and recent opinions from the U.S. Courts of Appeals for the Ninth and Fourth Circuits.

What will you gain

Attorneys will gain understanding of manufacturer obligations, covered entity eligibility, compliance conditions, and appellate court rulings affecting the 340B Program.

Agenda

SESSION 1

Workings of the 340B Program

SESSION 2

Notable 340B Program District Court Cases & the Pilot Program

SESSION 3

Sheldon (4th Circuit)

SESSION 4

Adventist Health (9th Circuit)

SESSION 5

Conclusion

clock 12:30 pm - 12:55 pm EST

Workings of the 340B Program

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

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.

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

clock 12:55 pm - 1:05 pm EST

Notable 340B Program District Court Cases & the Pilot Program

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

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.

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

clock 1:05 pm - 1:15 pm EST

Sheldon (4th Circuit)

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

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.

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

clock 1:15 pm - 1:25 pm EST

Adventist Health (9th Circuit)

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

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.

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

clock 1:25 pm - 1:30 pm EST

Conclusion

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

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.

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

01 05
Prev
Next

speakers

Joe Ervin

The Law Firm for Truck Safety, LLP
A Partner at The Law Firm for Truck Safety. He focuses exclusively on cases involving commercial motor vehicle crashes and wrongful death. Joe also holds a valid class “A” commercial driver’s license with endorsements for double/triple trailers and tankers.

Education & Credentials

A 2013 graduate of the Gerry Spence Trial Lawyers College in Dubois, Wyoming, Joe is rated AV Preeminent™ by Martindale-Hubbell — the highest peer rating for exceptional legal ability and ethics. He is among the first nine attorneys nationwide to earn board certification in Truck Accident Law from the National Board of Trial Advocacy.

Recognition & Leadership

Joe received the Roadway Safety Award from the American Association for Justice (AAJ) for his commitment to improving highway safety.
 He currently serves as Co-Chair of the Academy of Truck Accident Attorneys (ATAA) Safety Committee, advocating for higher safety standards across the trucking industry.

Professional Involvement

Joe serves on the faculty of the AAJ Advanced Trial Advocacy College: Litigating Truck Collision Cases (2015 & 2024).
 He is an active member of AAJ’s Trucking Litigation Group and sits on the Board of Regents for the Academy of Truck Accident Attorneys.

Experience

Joe frequently consults and co-counsels on complex commercial truck cases. His proven track record includes numerous successful trials against motor carriers and truck leasing companies — delivering justice for victims of commercial vehicle accidents.

Kevin Foley

Reminger Co
A Partner at The Law Firm for Truck Safety. He focuses exclusively on cases involving commercial motor vehicle crashes and wrongful death. Joe also holds a valid class “A” commercial driver’s license with endorsements for double/triple trailers and tankers.

Education & Credentials

A 2013 graduate of the Gerry Spence Trial Lawyers College in Dubois, Wyoming, Joe is rated AV Preeminent™ by Martindale-Hubbell — the highest peer rating for exceptional legal ability and ethics. He is among the first nine attorneys nationwide to earn board certification in Truck Accident Law from the National Board of Trial Advocacy.

Recognition & Leadership

Joe received the Roadway Safety Award from the American Association for Justice (AAJ) for his commitment to improving highway safety.
 He currently serves as Co-Chair of the Academy of Truck Accident Attorneys (ATAA) Safety Committee, advocating for higher safety standards across the trucking industry.

Professional Involvement

Joe serves on the faculty of the AAJ Advanced Trial Advocacy College: Litigating Truck Collision Cases (2015 & 2024).
 He is an active member of AAJ’s Trucking Litigation Group and sits on the Board of Regents for the Academy of Truck Accident Attorneys.

Experience

Joe frequently consults and co-counsels on complex commercial truck cases. His proven track record includes numerous successful trials against motor carriers and truck leasing companies — delivering justice for victims of commercial vehicle accidents.

Grant H. Lawson

The Law Firm for Truck Safety, LLP
A Partner at The Law Firm for Truck Safety. He focuses exclusively on cases involving commercial motor vehicle crashes and wrongful death. Joe also holds a valid class “A” commercial driver’s license with endorsements for double/triple trailers and tankers.

Education & Credentials

A 2013 graduate of the Gerry Spence Trial Lawyers College in Dubois, Wyoming, Joe is rated AV Preeminent™ by Martindale-Hubbell — the highest peer rating for exceptional legal ability and ethics. He is among the first nine attorneys nationwide to earn board certification in Truck Accident Law from the National Board of Trial Advocacy.

Recognition & Leadership

Joe received the Roadway Safety Award from the American Association for Justice (AAJ) for his commitment to improving highway safety.
 He currently serves as Co-Chair of the Academy of Truck Accident Attorneys (ATAA) Safety Committee, advocating for higher safety standards across the trucking industry.

Professional Involvement

Joe serves on the faculty of the AAJ Advanced Trial Advocacy College: Litigating Truck Collision Cases (2015 & 2024).
 He is an active member of AAJ’s Trucking Litigation Group and sits on the Board of Regents for the Academy of Truck Accident Attorneys.

Experience

Joe frequently consults and co-counsels on complex commercial truck cases. His proven track record includes numerous successful trials against motor carriers and truck leasing companies — delivering justice for victims of commercial vehicle accidents.

Rachel V. Rose

Rachel V. Rose – Attorney at Law, PLLC

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.

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.

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Price varies based
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Ability to Ask Questions During
the Presentation via a Chat Box
Included
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Exclusive Partner Webinars & Events
Special credits (Ethics, Elimination
of Bias, etc.)
Instant Certificates After Completion
Personalized CLE Platform
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Why Attend

Why this 
program matters

Attorneys advising healthcare clients must understand the 340B Program’s rapidly evolving compliance landscape and mounting litigation to protect covered entities from costly enforcement consequences.
$81B
in discounted outpatient drug purchases flowed through the 340B Program in 2024 — a 22.8% year-over-year increase.
46%
of HRSA-conducted 340B audits in 2024 resulted in adverse findings, triggering mandatory corrective action and potential manufacturer repayments.
5+
pharmaceutical manufacturers filed suit in D.C. Federal District Court in late 2024 challenging HRSA’s authority to reject proposed rebate models.
50k+
covered entities and 32,000 contract pharmacies now participate in the 340B Program, each subject to compliance conditions that can trigger repayment obligations or program removal.

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