The laboratory market continues to experience rapid innovation driven by emerging technologies, evolving CPT coding structures, coverage policy variation, and heightened focus on payment integrity. This session examines how changes at the CPT level influence downstream coverage and payment decisions, the growing importance of transparency in molecular and infectious disease testing, and the role of collaboration among CMS, the AMA, and laboratory stakeholders to support diagnostic innovation.

Medicare overpayment actions against molecular laboratories are accelerating, driven by UPIC audits, sophisticated data analytics, and evolving interpretations of national and local coverage policy. This session examines how overpayments are identified, the statutory and regulatory framework governing recoupment, and the billing patterns that most frequently trigger scrutiny. We will also explore extrapolation risk, documentation vulnerabilities, and the operational impact of payment suspension. Attendees will gain a practical framework for assessing exposure and implementing proactive compliance, documentation, and appeals strategies to mitigate financial disruption and reputational risk.

This session will provide a brief history of Medicare payment for clinical diagnostic laboratory services including the enactment and implementation of PAMA and recent legislative initiatives that could change how Medicare determines payment under the Clinical Laboratory Fee Schedule in the future.

The path from innovation to reimbursement to clinical adoption in digital pathology AI has been anything but straightforward. Using the ArteraAI Prostate Test as a case study, this session explores the journey of a laboratory developed test (LDT) to FDA De Novo–Authorized Software as a Medical Device (SaMD)—the first of its kind in pathology. This talk will cover coding, payment, and reimbursement challenges for AI algorithmic-only outputs; payer skepticism and emerging acceptance of AI-driven diagnostics; clinical evidence thresholds required for coverage decisions; and lessons from early AI diagnostic adoption and payer engagement.

This talk will review payor expectations and process for novel diagnostic tests. We will review the process for policy generation, how tests are evaluated, and provide an overview of the DEX registry and how technical assessments are performed.

The development and administration of health plan clinical policy is often slow, manual, and error-prone. This presentation will describe a ground-up approach to develop digitally native policy, structured for machine readability and maintained as a living data asset vetted by hundreds of clinical experts. These policies are deployed from the cloud to integrate into any clinical or reimbursement workflow, bringing transparency and clarity to providers, labs, payers, and patients.

Securing reimbursement for AI-driven diagnostics requires navigating a complex ecosystem of stakeholders. This session examines the practical challenges of aligning clinical innovation with rigid coding and benefit category determinations. Drawing on real-world experience across the regulatory and laboratory landscape, we will discuss strategies for managing stakeholder misalignment and establishing a path toward sustainable economic viability for computational diagnostics in an ever-shifting policy environment.

This presentation will outline what “health disparity” actually means in the diagnostics context, how payers operationalize access at the community level, and how labs can align test design, evidence, and deployment strategies with payer access and outcomes initiatives. Discussion points will include: defining health disparity as it relates to diagnostic coverage; how plans measure and operationalize access; aligning laboratory strategies with payer quality and access goals; and using access initiatives to strengthen a lab’s value proposition.

As payors automate denials at digital speed, laboratory administrative capacity is being pushed to its limit. Clarisa Blattner explores how Agentic AI enables real-time risk mitigation and operational consistency amidst increasing scrutiny and policy variability. Discover how AI-enabled execution directly impacts denial reduction, contract performance, and revenue predictability, moving beyond basic automation to protect reimbursement through intelligent, task-driven workflows in an era of automated payor friction.