Two developments moved diagnostic reimbursement and coverage: CMS granted Medicare reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989.55 per test, and a provision in the federal spending package would create a streamlined Medicare pathway for FDA‑approved multi‑cancer early detection (MCED) tests. Illumina’s CMS decision removes a key access and payment barrier for comprehensive genomic profiling in oncology. The appropriations bill measure would allow Medicare to cover certain FDA‑cleared MCEDs without waiting for USPSTF endorsement, establishing reimbursement timelines and initial eligibility ages starting in 2029—an industry priority that could materially shift MCED commercial dynamics.
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