A JAMA Network Open analysis using Medicare claims data found that next-generation sequencing (NGS) uptake for cancer testing rose after Medicare expanded national coverage in 2018, but access gaps persisted for some tumor types and among certain test categories. The study examined 391,151 Medicare beneficiaries from 2016 to 2023 across multiple cancer types. Researchers linked the coverage policy structure to ongoing variability. While FDA-approved NGS tests qualified automatically for Medicare under the national coverage determination, lab-developed tests (LDTs) performed in CLIA-certified settings without FDA approval continued to face regional coverage decisions. The results highlight a common operational gap: even when payer coverage expands, differences in FDA approval status and tumor eligibility can still shape whether patients can access comprehensive genomic profiling. For precision oncology stakeholders, the study supports continued efforts to align reimbursement policies with real-world clinical needs and to reduce fragmentation between FDA-approved assays and LDTs.
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