An analysis of U.S. Medicare claims data found that next-generation sequencing (NGS) uptake in cancer increased after Medicare began covering testing in 2018, but persistent access gaps remain for some tumor types—especially for lab-developed tests without FDA approval. Researchers assessed claims from 391,151 Medicare beneficiaries between 2016 and 2023. CMS’ national coverage policy covered FDA-approved NGS tests for stage III and stage IV cancers but left coverage decisions for lab-developed tests—performed in CLIA-certified labs—up to regional Medicare administrative contractors. The result was continuing variability even under national coverage. The findings underscore a practical barrier for precision oncology: coverage policy design (FDA approval pathways versus LDT regional determinations) can constrain broad clinical scaling of NGS panels despite broad payor intent.
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