CMS Finalizes SAINT Payment Stability and Major Reimbursement Gains for NeuroPace’s RNS System

CMS Finalizes SAINT Payment Stability and Major Reimbursement Gains for NeuroPace’s RNS System

CMS has finalized two separate 2026 rulings benefiting neuromodulation innovators: stable outpatient reimbursement for Magnus Medical’s SAINT therapy and significant payment increases for NeuroPace’s RNS System across physician and hospital settings. The updates strengthen patient access and support broader adoption of advanced brain-health technologies.

CMS Sets 2026 Medicare Premiums and Deductibles as Costs Rise and Policy Changes Take Effect

CMS Sets 2026 Medicare Premiums and Deductibles as Costs Rise and Policy Changes Take Effect

CMS Sets 2026 Medicare Premiums and Deductibles as Cost Pressures Mount and Regulatory Fixes Temper Increases The Centers for Medicare & Medicaid Services (CMS) has released the 2026 Medicare Parts A and B premiums, deductibles, and income-related adjustment amounts, outlining another year of steady cost increases across the program. While the updates reflect predictable inflationary … 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