CMS

Reimbursement Series: CMS and Europe Reimbursement Pathway Accelerates Innovation

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CMS and Europe reimbursement pathway

In a transformative week for market access, the CMS and Europe reimbursement pathway expansion delivered several pivotal coverage and pricing decisions reshaping patient access across cardiovascular, hepatic, and oncology therapies. From CMS’s national determinations on breakthrough devices to European HTA approvals in rare disease and cancer, these developments underscore a growing transatlantic alignment between regulators … Read more

Medicare Expands Signatera Genome MRD Assay Coverage

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Medicare has approved coverage for Natera’s genome-based Signatera molecular residual disease (MRD) assay under LCD L38779, extending access to beneficiaries across six cancer indications. The coverage applies to colorectal, breast, bladder, ovarian, and lung cancers, as well as pan-cancer immunotherapy monitoring, aligning with the scope of Natera’s original Signatera test. This regulatory milestone positions the … Read more