State biomarker testing coverage laws

United States, state statutes. Beginning with Illinois and Louisiana in 2021, states have passed laws requiring state-regulated health plans, and in most cases Medicaid, to cover biomarker testing when it is supported by an FDA label or indication, a Medicare national coverage determination, or nationally recognised clinical guidelines. The campaign is led by the American Cancer Society Cancer Action Network, whose tracker lists the states enacted each year. Primary text: each state's statute; the ACS CAN page links the model bill and the enacted laws.

What it changed: precision oncology depends on testing, yet surveys showed large gaps, particularly in community practice and among Medicaid patients, with prior authorisation and denials for multi-gene panels a common cause. The laws remove the coverage excuse for guideline-supported tests, including comprehensive next-generation sequencing panels and germline testing where guidelines recommend it, and usually require plans to have a clear, timely prior authorisation process.

The arguments: insurers warned of cost and of broad definitions covering unproven tests; sponsors answered that the guideline anchor limits coverage to tests with evidence and that untested patients receive the wrong or no targeted therapy. The laws do not reach the roughly half of employer plans regulated under federal ERISA law, which is why advocates also pursue Medicare coverage and federal parity. They complement Medicare's national coverage determination 90.2 for next-generation sequencing in advanced cancer.