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.

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.

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.