LA| The Louisiana Department of Insurance Bulletin 2025-05 provides guidance for health insurance issuers, HMOs, and self-insurers on compliance with the state’s Biomarker Law, which mandates coverage for biomarker testing relevant to patient diagnosis, treatment, and monitoring. The bulletin clarifies uniform application of coverage requirements, highlights limitations on insurers’ discretion, and emphasizes that clinical utility and coverage criteria must align with state law and the least restrictive medical evidence.
Key Points:
- Coverage for biomarker testing is required if the test’s clinical utility is demonstrated by at least one category of medical and scientific evidence (FDA approval, CMS coverage determinations, drug label warnings, or nationally recognized guidelines).
- Insurers may not apply additional or more restrictive criteria than those outlined in applicable Medicare or FDA benchmarks, ensuring patient access and limiting unnecessary disruptions in care, such as repeat biopsies or samples
- Medical policies used for biomarker testing coverage must explicitly reflect and defer to the Biomarker Law’s requirements, prevailing over any general or conflicting criteria in multi-state or generic insurer policies.