Navigating the fractured US healthcare system can be challenging but there is a basic recipe that test developers can use to plan their market access strategy. We will review evidentiary milestones and discuss some dos and don'ts for engaging stakeholders and refining your go-to-market strategy.

The US payer landscape is incredibly diverse, requiring laboratories to develop relationships with multiple public and private payers, in addition to laboratory benefit managers and other evidentiary review organizations, to assure reimbursement for their services. This session will explore the challenges of developing and maintaining unique claim submission processes to meet these requirements and discuss activities taken by stakeholders to respond to these issues.

Developing a market access strategy is complex, and it is critical to get the value proposition “right” to maximize success of the product. This session will discuss the value creation process for a molecular diagnostic product considering the multitude of stakeholders across the healthcare ecosystem. We will also explore the key considerations and steps to create a successful market access strategy.

Hundreds of new medical products are authorized by the FDA each year. New coding, coverage, and payment must be established for physicians and patients to reliably access a subset of novel technologies. Sandra will discuss an analysis of timelines from FDA authorization to Medicare coverage for 64 novel devices and diagnostics where coverage was achieved by 28 (44%) within a median of 5.7 years.

Medicare is a big factor for most lab tests, and its mix of national and local coverage policies is confusing. A proposal for Transitional Coverage for Emerging Technology is under review, for FDA-approved tests, while FDA's proposal to regulate all lab-developed tests would be chaotic for the ADLT pricing method. Meanwhile, Medicare struggles to price new genomic sequencing codes and the MolDx program expands to private payers. We'll update all these topics.

This talk will review the concepts and processes for molecular diagnostics payor controls. The discussion will include a description of 1) differentiating Medicare and private payors; 2) the difficulties of claims processing in molecular diagnostics; 3) DEX registry; 4) technical assessments; 5) how to approach Medicare for reimbursement; 6) policy-writing procedures for Medicare; 7) how payors consider evidence.

The process by which CMS establishes reimbursement rates for new codes appearing on the Medicare Clinical Laboratory Fee Schedule can be opaque and unpredictable, resulting in significant uncertainty for novel technologies entering the market. This presentation will discuss the crosswalk and gapfill processes, their impact on private payers and PAMA implementation, and potential policy solutions to improve them.