Wow. TCET Actually Happened.

Published on: 14/08/2024

A breakdown of the finalized TCET rule and what it means for Breakthrough Devices.

TCETMedicareNCDCEDEvidence DevelopmentEvidenceCMSCMS Device Nomination
Wow. TCET Actually Happened.

AI MedTech Reimbursement: Insights from Recent Literature

Published on: 13/08/2024

A review of what peer-reviewed publications reveal about payer adoption of AI tools.

AIAI MedTechMedicarePayer CoverageEvidenceCodingArtificial intelligenceHealth Technology AssessmentHTANovelValue-basedPayer Engagement
AI MedTech Reimbursement: Insights from Recent Literature

The Myth of ‘Build First, Worry Later’: Why Early Reimbursement Strategy is the Key to MedTech Survival

Published on: 03/08/2024

Why U.S. reimbursement strategy should begin long before FDA approval if you want to survive.

AIAI/MLReimbursement StrategyPayerPayer EngagementProduct DevelopmentHealthcare StakeholdersClinical UtilityEvidence
The Myth of ‘Build First, Worry Later’: Why Early Reimbursement Strategy is the Key to MedTech Survival

Beyond Medical Policy: Different Strategies for MedTech to Engage Payers

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 EngagementMedical Policy GapsPre-authorizationReimbursement StrategyClaimsMarket AccessValue-based ArrangementsVBAFee-For-ServicePay-for-PerformanceP4Pthird-party administratorsTPACost-Effectiveness AnalysisCenters of ExcellenceCOEReal-World DataRWDEvidencePayersPatient Advocacy GroupsDirect-to-ConsumerD2C
Beyond Medical Policy: Different Strategies for MedTech to Engage Payers