The evolving landscape of coverage and reimbursement for advanced diagnostics is shaped by recent trends in CPT coding. This session will explore how the CPT code set is adapting to market needs and addressing reporting for innovation. Attendees will gain insights into key developments in coding, influencing access, and payment for next-generation diagnostic services.

American Medical Association's Proprietary Laboratory Analyses (PLA) current procedural terminology (CPT) codes are a mechanism for novel laboratory assays to obtain a billing code specific for that assay. This session will overview the process and criteria for obtaining a PLA code as well as the Centers for Medicare and Medicaid's process for rate setting once a PLA code is obtained.

Hear the latest on rate-setting for laboratory CPT codes, and how to manage the pricing process. Get answers to frequently asked questions on what happens during the CMS annual rate-setting process. We’ll also discuss important considerations on engagement with CMS for innovative and complex test codes.

2025 is a year for rapid change in molecular test policy, from FDA's actions on lab-developed tests, to the growing impact of MolDx on commercial plans. This session highlights latest trends and changes in coding, local and national policy, and Medicare Advantage. How often do MACs issue new genomics LCDs, and how long does it take? Can anything be done to reduce the confusing text often found in policies? We'll update on summer policymaking proposals from CMS, the summer new-code meetings at CMS, and help you prepare your portfolio for 2026.

As increasing numbers of beneficiaries opt for Medicare Advantage (MA) coverage, it is crucial that laboratories understand how MA plans differ from Traditional Medicare and the implications for translating coverage policies into real-world reimbursement. This session will explore the challenges that laboratories face from prior authorization and other utilization management tactics used by MA plans and highlight current advocacy activities to respond to these challenges.

Too often, groundbreaking diagnostics reach the market only to struggle with reimbursement and payor adoption. By integrating market access strategies and considering payer requirements early in the product development process, we can improve adoption, streamline access, and truly deliver on the promise of better patient outcomes.

This session will examine a range of strategic approaches for obtaining payor coverage and reimbursement across both commercial and Medicaid markets. Through real-world case studies, we will highlight essential components for successful submissions and explore alternative pathways to achieving coverage. These examples will provide practical insights into navigating the complexities of the reimbursement landscape.

Twenty states and counting have enacted laws expanding insurance coverage of comprehensive biomarker testing across disease areas. Learn more about the impact of these laws, and how to maximize patient access to needed testing.

• Aligning Coverage with Transformative Value: Given the rapid evolution of diagnostics science, how can Medicare's "reasonable and necessary" coverage standard evolve to more flexibly and proactively incorporate transformative diagnostics to reshape care pathways rather than reacting to established evidence?
• Addressing the "Paradox" for Prevention and Early Detection: For innovative diagnostics focused on early disease detection or risk stratification (e.g., blood-based neurobiomarkers in early Alzheimer’s Disease detection, host response to infection assays to determine the need for antimicrobial therapy), how can CMS better capture the short and long-term value in improved outcomes and avoidance of more costly downstream interventions? How could CMS “reward” manufacturers and other developers for these critical diagnostics innovations?
• Predictability vs. Flexibility: Striking the Right Balance for Innovation: How should Medicare's national and local coverage and payment determination processes offer greater predictability for diagnostic innovators to plan R&D investments, while simultaneously maintaining enough flexibility to adapt to breakthrough technologies and rapidly evolving clinical value?
• Adapting RCT Requirements for Diagnostic Paradigms: Given the unique characteristics of diagnostics—often impacting decision-making rather than direct intervention, coupled with the longer time horizon to demonstrate ultimate outcomes in Medicare populations—how can Medicare’s general reliance on prospective randomized clinical trials be adapted to foster innovation without imposing unfeasible burdens? What alternative or complementary evidence generation approaches (e.g., real-world evidence, virtual clinical utility studies) should CMS and its Contractors accept when evaluating coverage for novel diagnostics when traditional RCTs are impractical or unethical?​

• The Five Questions for Coding: Who, What, When, Where and How for Innovative Diagnostics
• Why Coding Matters and What Role it Plays in Medicare Payment
• Key Steps for Innovators Before Beginning the Coding Journey​