Substitute Senate Bill No. 307, known as Public Act No. 24-50, is a legislative act concerning Medicaid coverage of biomarker testing, set to be effective from July 1, 2024. The bill defines "biomarker" as a measurable characteristic that indicates biological or pathogenic processes or responses to therapeutic interventions. "Biomarker testing" is the analysis of a patient's biospecimen to detect such biomarkers. The bill also defines "clinical utility" as test results that contribute to treatment or monitoring strategies affecting patient outcomes and clinical decisions. It includes definitions for "consensus statements" and "nationally recognized clinical practice guidelines," which are developed by expert panels and organizations to optimize clinical care outcomes based on evidence.
The bill mandates that the Commissioner of Social Services provide Medicaid coverage for biomarker testing for diagnosis, treatment, management, or monitoring of a Medicaid enrollee's disease or condition, as long as it is medically necessary and permissible under federal law. Coverage decisions will be informed by medical and scientific evidence, FDA approvals, Medicare coverage determinations, and clinical practice guidelines. The act specifies that existing guidelines should not be the sole basis for final medical necessity determinations. It also allows the Department of Social Services to require prior authorization for testing and provides Medicaid enrollees the right to request a hearing if adversely affected by the department's decision. The Commissioner is tasked with ensuring that coverage is provided in a way that minimizes disruptions in care.