MD| The Mayland Insurance Administration‘s bulletin 26-15 explains that, under Maryland Insurance Article §15‑859, carriers must cover medically necessary biomarker testing used for diagnosis, treatment, management, or ongoing monitoring of disease when supported by specified categories of medical and scientific evidence, including FDA‑cleared/approved tests, tests tied to FDA drug labeling, CMS National or Local Coverage Determinations, or nationally recognized clinical practice guidelines that meet defined methodological standards. Coverage applies to grandfathered and non‑grandfathered large group health benefit plans and grandfathered individual plans, but not to non‑grandfathered individual and small employer markets because the mandate is not included in the State benchmark plan and the statute does not override §31‑116.
The Maryland Insurance Administration clarifies that carriers may apply medical necessity review only in a manner consistent with the Biomarker Law, must cover tests when used for the statute’s scientifically supported purposes even if results include both actionable and currently non‑actionable information, may not impose additional or different coverage criteria beyond those in applicable Medicare LCDs, and must administer coverage in a way that minimizes disruption in care, including avoiding unnecessary repeat biopsies or biospecimen collections.