Innovative diagnostics labs depend on coverage decisions, especially from Medicare. But how are they really made? Understand how CMS drafts and finalizes national decisions (NCDs), and successful and unsuccessful approaches to public comment. For the MolDx program, we analyze recent local decisions (LCDs), assess how to make effective comments, explain how LCDs are revised, and what timelines to expect. We also assess how long it takes MolDx LCDs to be adopted across the 29 states in the MolDx program, and how their Master Edit File works.

The diagnostics industry has continued to evolve at a breakneck pace. Payer reimbursement models are advancing as well. Hear from two industry experts about how payers, particularly Medicare, are changing the way that diagnostics are paid for, and learn why developers need to incorporate a sound reimbursement strategy into their product commercialization plans.

The increasing complexity of cancer care and accelerated approvals of targeted and immuno-oncology therapies has shifted CDx testing from a one test-one drug approach to a next-generation sequencing (NGS)-based multi-gene approach. Despite recent improvements, coverage and reimbursement remains fragmented and challenging for NGS testing.

The current paradigm for coverage and reimbursement involves seeking a code and seeking reimbursement from government payers, and then transitioning to the commercial and managed care settings. This paradigm is not an optimal framework to achieve value-based reimbursement for advanced diagnostics. This presentation will explore other options for seeking more reasonable reimbursement for advanced diagnostics. It will also discuss the evolving history of seeking reimbursement in a pandemic, and focus on coverage and reimbursement for tests for the diagnosis of COVID-19.

In order to create market pull for diagnostics for the benefit of all stakeholders in healthcare, payers and diagnostic developers need to work together to come to agreement on key principles around clinical validation, clinical utility and economics. Early engagement allows for clarity for both parties, creating partnerships instead of the usually adversarial relationships.

Key discussion points to be addressed:

• How do you define what ‘enough data’ is?
• How do you determine the ‘right data’?
• How do you get early payer stakeholder engagement?

Liquid biopsy represents a revolution in cancer care, precipitating seismic paradigm shifts: (1) from tissue- to liquid-diagnosis; (2) from single- to multi-gene panels; (3) from tumor-specific to tumor-agnostic diagnosis and treatment; and (4) from late-stage detection to screening. The acceptance (and consequential reimbursement) of liquid biopsy will depend upon these pivotal transitions in thought and technology.

The testing paradigm in precision oncology is growing increasingly complex, including multi-gene, multi-modality approaches. Add to this the considerations of clinical, policy, and funding stakeholders and geographic variability in test access, and routine companion diagnostic testing becomes a goal that often takes too long to reach. The talk outlines typical barriers encountered, and some key planning and mitigation approaches that biopharmaceutical and diagnostics companies can take to meet key commercial implementation challenges in precision medicine.

Access and reimbursement are key factors in a successful diagnostic product go-to-market strategy. For a companion diagnostic, the complexity increases based on the pharmaceutical partner(s)’ drug access timeline, regulatory considerations, and fast changing or opaque in-country diagnostic access framework. This session will outline some key considerations in building a roadmap for CDx access.

• Aligning commercialization activities and timelines
• Understanding global commercial dynamics and complexity
• Best practices in establishing partnerships: Cross-industry, payers, distributors, etc.
• Stakeholder engagement and value communication