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 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.

Point-of-care testing is evolving from a product category into the organizing logic of large diagnostic portfolios. As care decentralizes across outpatient, retail, and home settings, leading IVD companies are reshaping strategy around near-patient molecular, continuous monitoring, and consumer-driven platforms. This talk examines how Abbott, Roche, Cepheid, bioMérieux, and others are redefining competitive advantage, and how near-patient, point-of-care, and at-home testing will accelerate portfolio transformation.

The iconic line from the movie highlights the true challenge for successful POCT commercialization: creating a patient understandable value proposition where they connect the value of the test(s) to access knowledge and control of their health and are willing to pay directly for it.  

Companies must also demonstrate to doctors the scope of the losses that they accrue on every send-out test.  

The self-pay patient model works great for in-office services but not for send out lab orders.

POCT Commercialization Must Haves:

• Patient Understandable Value Proposition
• Defined Revenue per run for Doctors
• Cash-based Profitability Model?

Point-of-care testing is essential to timely diagnosis and treatment in Urgent Care, yet adoption often hinges on payment policy rather than clinical value. This session highlights how the Urgent Care Association’s advocacy work seeks to align Medicare reimbursement with the capabilities of enhanced urgent care centers. It explains why sustainable payment matters for diagnostic readiness and access, and how effective advocacy can accelerate adoption of point-of-care testing nationwide.