This talk will explore the complexities of molecular diagnostic billing for Medicare and provide explanations of the processes and requirements of submitting for coverage and reimbursement under existing or prospective policies.

An overview of key considerations for advanced diagnostic innovators to achieve reimbursement success in a competitive environment. This presentation will provide insights into how reimbursement planning can be incorporated into test development to optimize coverage and payment, observations on market access strategies that work and ones that don’t, and pitfalls to avoid when launching advanced molecular diagnostics in the marketplace.

• Diagnostic technology continues to evolve, but government reimbursement policies have not fundamentally changed since the 1990s. To what extent should we question the viability and effectiveness of employing policies that were formulated three decades ago in a market that is constantly undergoing rapid transformations?
• In what ways can government reimbursement strategies for diagnostic testing be optimized to strike a balance between incentivizing innovation and ensuring accessibility and affordability for patients, considering the evolving nature of healthcare technologies and the need for continuous advancements in diagnostic capabilities?
• What potential consequences could arise from either encouraging or discouraging innovation through updated reimbursement policies?

For the past several years, there has been substantial debate among policymakers and various stakeholders regarding modernization of regulatory oversight for diagnostic tests to ensure performance quality. This session will explore recent trends for diagnostic tests use in cancer, case examples of variability in results from different tests, and, in the absence of regulatory modifications, whether payers will take a more active role in test performance standards.

The US payer landscape is incredibly diverse, requiring laboratories to develop relationships with multiple public and private payers in order to assure reimbursement for their services. Over the years, this landscape has continued to evolve with the growing addition of laboratory benefit managers and other evidentiary review organizations. Clinical laboratories are currently faced with the daunting prospect of developing and maintaining unique claim submission processes to meet all these requirements. This session will explore the challenge these requirements pose for reimbursement and discuss activities taken by stakeholders to respond to these issues. 

As technology surges, and a virus changes the world, what trends are emerging in how diagnostic procedures are covered by health plans and reimbursed?

The decision to embrace precision oncology is a complex one, with different paths pursued depending on one’s perspective as a patient, physician, pathologist, or payer. This presentation outlines these parallel journeys in the context of the groundbreaking technology of liquid biopsy in uncovering the specific genomic drivers of cancer so that they may be more precisely targeted.

Automation and Artificial Intelligence platforms are becoming more commonplace in today's lab environment. Deploying these kinds of solutions to address reductions in staffing and increases in workloads is becoming more and more evident in today's laboratories. But what are the implications of these advancements on Government reimbursements? Explore the policies underpinning Medicare reimbursement for lab services and how those policies may not be able to continue to keep up with changing technology.

The reimbursement landscape for multiplex testing has been shifting and evolving consistently since 2018, made all the more complicated by mandates and guidance issued as part of the COVID-19 Public Health Emergency. This session will provide some historical context around multiplex test access, key policies that have driven changes, and to what extent the COVID-19 PHE and its expiration may impact multiplex test reimbursement and access into the future.