A new analysis of Medicare claims data found that even after CMS expanded national coverage for certain FDA-approved next-generation sequencing tests in advanced cancers, uptake and access remained uneven across tumor types and testing categories. Published in JAMA Network Open, the study followed 391,151 Medicare beneficiaries with lung, breast, colorectal, prostate, or endometrial cancer from 2016–2023. Researchers reported that NGS use increased over time, but access gaps persisted, particularly involving lab-developed tests in CLIA-certified settings that did not have FDA approval. The coverage policy was designed to automatically cover FDA-approved NGS tests for eligible patients, while leaving some other testing decisions to regional Medicare administrative contractors. The findings highlight that payer coverage simplification does not automatically translate to uniform on-the-ground testing availability, emphasizing operational and eligibility bottlenecks that remain relevant for precision oncology programs.
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