A JAMA Network Open study using seven years of Medicare claims data found that uptake of next-generation sequencing (NGS) in cancer rose after CMS expanded national coverage in 2018, but access gaps persisted—especially for patients with certain tumor types. Researchers analyzed claims from 391,151 Medicare beneficiaries across multiple cancers to assess how coverage policy translated into real-world ordering. The analysis highlights that while FDA-approved NGS tests automatically qualified for Medicare coverage under the national determination, coverage for lab-developed tests in CLIA-certified settings remained tied to regional Medicare administrative contractors. That structure limited how consistently non-FDA–approved offerings were reimbursed across the U.S. The study also notes that after the 2018 coverage change, more labs pursued FDA approval for their oncology NGS profiling tests—including major commercial players—suggesting payer policy and regulatory alignment materially affect which assays patients can access.
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