GA| Bulletin 25-EX-7, issued by Georgia’s Insurance Commissioner, reminds all Georgia health benefit policies, including state employee plans, that O.C.G.A. § 33-24-59.33 requires coverage of biomarker testing for diagnosis, treatment, management, or monitoring of a disease when supported by at least one of five criteria: FDA-approved or cleared tests with labeled indications, tests indicated in or tied to FDA-approved drug labeling and warnings, CMS national or local coverage determinations, or nationally recognized clinical practice guidelines and consensus statements. Plans must provide this coverage in a way that minimizes care disruptions, such as avoiding multiple biopsies, and must maintain an easily accessible online process for requesting exceptions and appealing adverse determinations, with adherence to expedited timelines for urgent medical necessity. The Bulletin provides a non-exhaustive list of covered biomarker test categories and warns that the Department of Insurance will take regulatory action as needed to enforce compliance.
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