First Report Managed CareWhat Insurance Plans Need to Know About Biomarker Legislation

Navigating the Evolving Landscape of Biomarker Legislation: Implications for Precision Medicine

In an era where precision medicine is rapidly advancing, biomarker legislation emerges as a critical juncture for healthcare professionals, particularly physicians, to navigate. This evolving legislative landscape, while rooted in commendable intentions, presents a complex interplay of mandates, coverage implications, and operational adjustments for health insurers, directly impacting the clinical application and accessibility of biomarker testing for patients.

Key Points:

• Fourteen states have enacted biomarker legislation, with more expected, mandating insurance coverage for biomarker testing based on clinical utility backed by evidence such as FDA approval and clinical guidelines.
• The legislation lacks precise definitions for “biomarker testing” and “clinical practice guidelines,” leading to potential variability in coverage and implementation.
• The biomarker bills typically permit prior authorization, set decision deadlines, and require an accessible appeals process for coverage denials.
• Benefits of these bills include increased awareness of biomarker testing, encouragement for insurance plans to cover new tests, and potential reduction in healthcare disparities.
• Concerns include the vagueness of the bills, the risk of inappropriate test usage, the potential for rising healthcare costs and premiums, and implementation inconsistencies.
• Health plans are advised to closely monitor legislative developments, review and adapt coverage policies, and learn from the implementation experiences of early adopter states.
• Lab management companies can assist insurers in adhering to the legislation by evaluating tests for clinical utility and establishing scientifically rigorous policies.
• A 2020 study highlighted that broad panel biomarker testing in non-small cell lung cancer patients could significantly reduce healthcare costs, demonstrating the economic and clinical value of precise biomarker testing.

The American Society of Clinical Oncology estimates that routinely testing people with colon cancer for mutations in the K-RAS oncogene would save at least US $600 million a year.

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