CMS Sets $1,352 Payment Rate for Pillar’s oncoReveal CDx

CMS Sets $1,352 Payment Rate for Pillar’s oncoReveal CDx

CMS has issued its final payment determination for Pillar Biosciences’ oncoReveal CDx, confirming a crosswalk-based national rate of $1,352.09, service beginning January 1, 2026. The decision, which aligns with CMS’ preliminary ruling from August, marks a meaningful advance for Medicare beneficiaries and reinforces oncoReveal CDx’s position as a front-line, multi-cancer NGS testing kit in the … Read more

Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 24, 2025

Weekly Pulse Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 24, 2025

The Reimbursement Landscape Recalibrates As we pause for the Thanksgiving holiday, a sincere thank-you to our readers and partners for your continued engagement. This week’s update reflects a period of meaningful policymaking momentum across major global agencies. Across the U.S., UK, France, Canada and Thailand, agencies delivered firm, directional decisions that shape how hospitals, clinics … Read more

CMS Sets New Medicare 2026 Rates Across Five Innovation Categories

CMS Sets New Medicare 2026 Rates Across Five Innovation Categories

What the New Medicare 2026 Rates Mean for Access and Adoption The U.S. Centers for Medicare & Medicaid Services (CMS) has delivered a rare cluster of reimbursement decisions that collectively mark one of the most significant access-defining weeks of 2025. Spanning neuromodulation, molecular diagnostics, AI imaging, autoimmune disease therapy, and oncology support care, the rulings … Read more

Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 10, 2025

Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 10, 2025

The Week’s Biggest Shifts in Payer Strategy This week’s policy and access landscape was defined by a sweeping overhaul of U.S. Medicaid drug pricing and a widening push toward value-driven reimbursement models. CMS’ newly announced GENEROUS model, paired with Most Favored Nation (MFN) pricing agreements for GLP-1s, marks a structural shift that will reshape affordability … Read more

Reimbursement Series: CMS and Europe Reimbursement Pathway Accelerates Innovation

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

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