From FDA Review to Payment: Understanding the Regulatory-Reimbursement Connection

Clinical laboratories are navigating a changing landscape where regulatory decisions increasingly influence reimbursement outcomes. While some laboratory developed tests can reach the market without FDA review, evolving policies and coverage frameworks are raising important questions about how regulatory strategy may affect payer acceptance, coding pathways, and long-term financial performance.

In this educational webinar, regulatory attorney Christine Bump of Penn Avenue Law and Ann Lambrix, Executive Director of RCM Consulting at Lighthouse Lab Services, will examine the growing relationship between regulatory positioning and reimbursement strategy. Attendees will gain insight into how intended use language, clinical utility evidence, FDA pathways, and payer expectations can shape coverage decisions and reimbursement opportunities.

The discussion will also explore emerging developments affecting laboratory reimbursement, including changes within MolDx and what they may signal for the future of molecular diagnostics coverage and policy direction.

Learning objectives:

• Understand how FDA review pathways may influence reimbursement and payer adoption strategies
• Explore the distinction between intended use and clinical utility and why it matters for coverage decisions
• Review the RAPID program and other evolving pathways supporting breakthrough technologies
• Examine Medicare coverage considerations for multicancer early detection (MCED) testing
• Discuss emerging reimbursement and coverage trends affecting clinical laboratories
• Understand recent MolDx developments and potential implications for laboratory strategy moving forward

This session is designed for:

-Lab Owners and Stakeholders
-Regulatory Consultants
-Revenue Cycle and Billing Leaders
-Pathologists
-Lab Compliance Advisors
-Bench-Level Scientists seeking to gain a broader understanding of ongoing regulations