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Utilization Management in the Age of Biomarker Legislation

The movement toward biomarker legislation began with the honorable goal of ensuring individuals battling cancer have equal access to biomarker testing. In the oncology clinical setting, this type of testing has clear utility in directing the use of targeted, advanced and emerging therapies.

However, as legislative efforts progress, the scope of “biomarker” extends beyond oncology, presenting significant challenges. While legislation aims to enhance access and transparency, its broad language leaves payors struggling with implementation.

Multiple states have enacted biomarker legislation, with more to follow throughout 2024, guided by a template from the National Council of Insurance Legislators (NCOIL). Yet, NCOIL’s format is written in a way that permits modification of any portion by individual state legislators, preventing consistent application and creating ambiguity and confusion.

What is clear? The need for genetics experts to navigate this rapidly evolving landscape.

Download this white paper for an expert review and assessment that will help you understand:

  • At-a-glance, the current biomarker legislative landscape across the US – which states have made moves and who’s left to act
  • Financial implications of expanded biomarker coverage concerning payor cost management and billing practices
  • Challenges posed by Laboratory Developed Tests (LDTs), lacking regulatory oversight, underscoring the need for rigorous evidence review to ensure quality and efficacy
  • The role of genetics experts in evidentiary review and clinical decision-making as essential for navigating legislative mandates effectively.

The FDA estimates approximately 600 to 2400 laboratories are CLIA certified and offering laboratory developed tests.

*FDA to Regulate Lab Developed Tests (LDTs) as Early as 2025. Oriel STAT A MATRIX. October 4, 2023.
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A robust utilization management program guided by genetics expertise will become increasingly important in the evolving era of biomarker legislation.

There is still time – health plans who partner with genomics experts can still ensure prudent utilization of biomarker testing, safeguarding both fiscal responsibility and patient care.

Download this white paper today!

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