Do QALYs Matter in the U.S.?
Nicole Coustier Published on: 11/03/2025
QALYs are essential in Europe—but not in the U.S. Here's what really drives MedTech coverage decisions and how to pivot.
U.S. Healthcare Fundamentals
Nicole Coustier
Payer Policy Is Poised to Unlock the Full Potential of AI in MedTech in 2025
Nicole Coustier Published on: 17/12/2024
U.S. payers are evolving fast. Here’s how AI-driven MedTech innovators can lead—not wait—for reimbursement models.
Payer Coverage
Medicare Proposes to Approve 80% of Transitional Pass Through Applications for Novel Tech in 2025
Nicole Coustier Published on: 25/08/2024
CMS is signaling support for innovation. Here's what this policy shift could mean for your device.
Coding and Payment Mechanics
Wow. TCET Actually Happened.
Nicole Coustier Published on: 14/08/2024
A breakdown of the finalized TCET rule and what it means for Breakthrough Devices.
Coding and Payment Mechanics
Relearning English When it Comes to FDA and CMS Jargon
Nicole Coustier Published on: 04/06/2024
MedTech teams often misunderstand what regulators mean. This article translates FDA and CMS jargon into actionable insights for reimbursement.
U.S. Healthcare FundamentalsFeatured
FDA vs. CMS Mandates for Evaluating Novel MedTech
Nicole Coustier Published on: 31/05/2024
FDA approval ensures safety and effectiveness—but CMS needs proof of clinical value. Here’s how to align your strategy with both mandates.
Evidence Planning