From Courts to Congress: Navigating the Healthcare Policy Landscape in 2024

Monday, October 21, 2024

5:30 PM - 6:30 PM

Location: Grand Ballroom C

CE: 1 CME (AMA Physician Credit) / 1 CE (Non-Physician Credit)

Program Chair(s)

ZS

Zbigniew Szczepiorkowski, MD, PhD

Professor of Pathology and Laboratory Medicine/Director of Cellular Therapy Center
Dartmouth Health
Lebanon, New Hampshire, United States

Disclosure(s): Cellphire: Research Study (Ongoing); Fresenius Kabi: Consultant/Advisory Board (Ongoing), Grant/Research Support (Ongoing); Hemanext: Grant/Research Support (Ongoing)

Speaker(s)

Meghan Delaney, DO, MPH

Chief, Pathology & Laboratory Medicine
Childrens National Hospital
Washington, District of Columbia, United States

Disclosure(s): No financial relationships to disclose
LS

Leah Stone, JD

Vice President, Public Policy and Advocacy
Association for the Advancement of Blood and Biotherapies
Bethesda, Maryland, United States

Disclosure(s): No financial relationships to disclose

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Disclosure(s):

Zbigniew M. Szczepiorkowski, MD, PhD: Cellphire: Research Study (Ongoing); Fresenius Kabi: Consultant/Advisory Board (Ongoing), Grant/Research Support (Ongoing); Hemanext: Grant/Research Support (Ongoing)

Meghan Delaney, DO, MPH: No financial relationships to disclose

Leah Mendelsohn Stone, JD: No financial relationships to disclose

In today’s rapidly evolving healthcare environment, understanding the latest policy developments is crucial for strategic planning and operational success. This session will explore the significant implications of the recent Supreme Court decision – Loper Bright Enterprises v. Raimondo – which overturned a 40-year-old legal precedent that afforded federal agencies with significant discretion in interpreting the laws that they are charged with implementing. The landmark ruling may fundamentally change the way that Congress, Federal agencies, and the courts interact, and may have a substantial impact on healthcare policies.

The session will dive into a case study of one issue that crosses Congress, Federal agencies and the courts. After years of Congressional efforts to regulate laboratory developed tests (LDTs), in 2024 the Food and Drug Administration (FDA) finalized a rule that regulates LDTs as medical devices. FDA is moving forward with implementing the final rule. However, two lawsuits have been filed that challenge the final rule, and some members of Congress remain interested in a legislative solution. This session will highlight one member’s experience leading efforts to shape public policies related to LDTs and will offer insights into preparing for the final rule to take effect.

Attendees will have a greater understanding of the current health policy landscape, which will help them prepare for the future.

Learning Objectives:

Gain insights into a recent Supreme Court decision – Loper Bright Enterprises v. Raimondo – and understand why it has the potential to significantly influence healthcare policies.
Explore the case study of laboratory developed tests (LDTs), focusing on FDA’s ongoing implementation of the 2024 final rule, and the legal and legislative challenges that may influence this policy area.
Gain insights from a member’s firsthand experience in leading efforts to shape public policies related to LDTs, providing practical strategies and lessons for effective advocacy in the evolving healthcare policy landscape.