The ultimate update on genomics at Medicare, covering events up until early March 2025. We'll discuss what's new with the maze of codes comprehensive genomic panel—and how the prices are being set. Next, we'll turn to the proliferation of MolDx "Z Codes," now tailored to specific different patients and situations. We'll discuss what's happening in all the MACs outside of MolDx—like NGS MAC and Novitas. Finally, we'll review how FDA approval and FDA breakthrough status is shaping coverage at CMS.

The US payer landscape is incredibly diverse with public and private payers, in addition to laboratory benefit managers that use constantly evolving prior authorization and other utilization management procedures. This session will explore current trends in utilization management procedures for laboratory services and highlight current advocacy activities to respond to these issues.

The clinical laboratory is a source of financial toxicity to patients. Here, we present common examples of financial toxicity in clinical lab services and discuss 7 achievable goals to help patients avoid financial toxicity and seek necessary care. Learning objectives: 1) define financial toxicity in medical care, giving examples from lab testing; 2) describe 7 goals to decrease financial toxicity; 3) describe how reference lab relationships can benefit or harm the continuum of clinical lab care; 4) compare and contrast free testing, patient forgiveness programs, and charity care; explain why inpatient testing is not “free.”

When planning for a market launch of a novel diagnostic in the US market, obstacles present themselves. Does my assay qualify for a Cat I code? Is it better to seek a Cat III code? Is it better to obtain a PLA code or an Administrative MAAA code? Are there downstream issues in these decisions? Will the coding pathway (involving the CAP-controlled groups like the Pathology Coding Caucus) matter? Should I seek a crosswalk or gapfill price? The session will illustrate examples and provide some guidance.

The FDA authorizes hundreds of new medical devices and diagnostics annually, yet coverage, above nearly all other factors, has become the lynchpin for patient and physician access. Sandra will discuss research from the Stanford Mussallem Center for Biodesign Policy Program that sheds light on this landscape and opportunities for policy change.

During this session, we will discuss: 1) variation in coverage policies across the payer landscape and its root sources; 2) the challenges payers, labs, and providers face in determining whether a test will be covered; and 3) current and future solutions to bring clarity, consistency, and affordability to precision diagnostics.

This talk will focus on describing processes and procedures payors, including that Medicare must follow, how they make decisions, and how payor control tools created by MolDX can be used to make better and more reproducible coverage decisions.