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.
Payer Coverage
Nicole Coustier
AI MedTech Reimbursement: Insights from Recent Literature
Nicole Coustier Published on: 13/08/2024
A review of what peer-reviewed publications reveal about payer adoption of AI tools.
Payer CoverageEvidence Planning
The Myth of ‘Build First, Worry Later’: Why Early Reimbursement Strategy is the Key to MedTech Survival
Nicole Coustier Published on: 03/08/2024
Why U.S. reimbursement strategy should begin long before FDA approval if you want to survive.
Coding and PaymentCommercialization
Beyond Medical Policy: Different Strategies for MedTech to Engage Payers
Nicole Coustier Published on: 05/06/2024
Not every MedTech device gets written into policy. Here’s how to engage U.S. payers even when your innovation falls outside the playbook.
Payer CoverageCommercialization
What Do Payers Mean by “Clinical Utility”?
Nicole Coustier Published on: 01/06/2024
“Clinical utility” is one of the most misunderstood payer terms. This article explains what U.S. payers expect and how to prepare.
Payer CoverageEvidence Planning
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 PlanningCommercializationFundamentals