Senate Substitute Bill No. 307, identified as File No. 317, is a legislative proposal concerning Medicaid coverage of biomarker testing. The bill, effective July 1, 2024, mandates that the Commissioner of Social Services provide coverage for biomarker testing within the Medicaid program, to the extent permissible under federal law. Biomarker testing is defined as the analysis of a patient's tissue, blood, or other biospecimens for biomarkers, which are characteristics that can be objectively measured and evaluated as indicators of normal or pathogenic processes, or responses to therapeutic interventions for a disease or condition. This includes tests for single or multiple substances, diseases, conditions, and whole genome sequencing.

The coverage for biomarker testing is conditioned on medical and scientific evidence, which may include FDA approval, recommendations on FDA-approved drug labels, national or local Medicare coverage determinations, nationally recognized clinical practice guidelines, consensus statements, or other sources for establishing medical necessity. The bill also clarifies that the Department of Social Services retains the ability to require prior authorization to ensure that biomarker testing requests meet the established standards. The bill includes insertions that specify the file number (File No. 317) and the effective date (July 1, 2024), and it makes minor language changes for consistency and clarity. The fiscal impact statement indicates that there is no anticipated fiscal impact to the Department of Social Services, as the bill maintains prior authorization and medical necessity conditions, and biomarker testing is already covered. However, should coverage be expanded beyond current medical necessity definitions, there could be increased Medicaid costs.