LUGPA Policy Update: Advancing Biomarker Testing Access for Precision Medicine

March 2024

In today's landscape of advancing cancer care, biomarker testing stands as a crucial gateway to precision medicine, offering tailored treatment options that can significantly enhance patient outcomes and quality of life. However, disparities in access to these innovations persist across communities, posing a barrier to equitable healthcare.

Biomarker testing, integral to precision medicine, is pivotal for disease management and treatment selection. However, limited awareness, unclear terminology, and restrictive coverage policies hinder patient access to such testing, impeding potential health benefits. Collaborative efforts between patients, providers, and industry advocates are crucial in addressing these barriers by aligning with policymakers at the state level to enhance access and promote better outcomes.

Biomarkers, including proteins, genes, or gene mutations, serve as vital indicators in disease management, particularly in cancer care. Testing involves analyzing patient samples to detect these indicators and guiding personalized treatment decisions based on genetic characteristics. By streamlining testing processes and understanding biomarker significance, healthcare stakeholders can significantly improve patient care and outcomes in precision medicine.

LUGPA has joined a new collaboration with national healthcare advocacy groups to champion legislative initiatives aimed at ensuring comprehensive coverage of biomarker testing by insurers, including Medicaid programs. The group effort, led by the American Cancer Society Cancer Action Network, yielded model legislation outlining coverage requirements and eligibility criteria for biomarker testing.

Under this legislation, health insurers and Medicaid programs are mandated to cover biomarker testing for purposes such as diagnosis, treatment, and disease management, provided the test is supported by robust medical and scientific evidence. This evidence encompasses FDA approvals, clinical guidelines, and consensus statements, ensuring rigorous standards are met.

Furthermore, the legislation addresses utilization review processes, emphasizing timely approval or denial of prior authorization requests and establishing clear pathways for exceptions to coverage policies. Additionally, it stipulates that risk-bearing entities contracted to Medicaid programs must provide biomarker testing at the same level as the program itself.

The collective effort on biomarker testing is driven by a commitment to expanding access to biomarker testing, thereby democratizing the benefits of precision medicine for all patients, regardless of income or geographical location. By streamlining authorization processes and promoting evidence-based coverage, we aim to bridge existing gaps in healthcare access and propel advancements in patient-centered care.

The core goals of these efforts revolve around advancing awareness and education regarding comprehensive biomarker testing and precision medicine across various stakeholders, including patients, providers, and policymakers. A key focus is on reducing health disparities by improving access to comprehensive biomarker testing, ensuring that all insurers universally cover appropriate biomarker testing and precision medicines to optimize health outcomes. Additionally, these efforts aim to facilitate access to innovative biomarker testing and precision medicines through active participation in clinical trials. By addressing these objectives, the aim is to promote equitable access to cutting-edge medical technologies and treatments, ultimately improving healthcare outcomes for all.