Clinical Trial Reimbursement in the U.S.: FAQs for MedTech Companies
Published on: 19/03/2025
A clear FAQ guide on how MedTech startups can secure Medicare reimbursement for clinical trials—and when it’s worth it.
Clinical trial reimbursementMedicare IDE coverageCategory B device reimbursementCMS clinical trial processMedTech clinical trial fundingpayer validationtrial pricing strategybilling modifiersMedicare compliancepatient enrollment delayssite engagementproduction cost justificationreimbursement infrastructurehow to get Medicare to reimburse your clinical trialpros and cons of clinical trial reimbursement for medical devices
Beware Basing Your MedTech Pricing on Short-term New Tech Payment Mechanisms
Published on: 04/03/2025
New tech payments like NTAP can’t justify long-term pricing. Here’s what MedTech founders need to know.
medtech pricing strategyNTAP pricing risksTPT reimbursementstakeholder value alignmenttransitional payment pitfallsCMS payment timelineshospital cost recoverypayer resistancephysician economicsCPT code impactDRG payment pressure short-term vs long-term incentivespricing justification errorshow to price a medical device beyond NTAPwhy short-term reimbursement can't support long-term pricing
The Hidden Bias in Reimbursement: Why First Movers May Have It Easier
Published on: 06/02/2025
Why do better technologies struggle for reimbursement while outdated ones thrive? Discover the hidden bias in payer decision-making—and why second movers in MedTech face steeper evidence hurdles than the first.
first-mover advantage in reimbursementreimbursement strategy for medical devicespayer evidence requirementsMedTech reimbursement challengescomparative coverage thresholdsclinical trial evidenceCMS policyhealthcare payerscoverage approvalmarket accesscoding and paymentreal-world evidencemedical device innovationwhy it’s harder for new MedTech companies to get coveragehow to compete with an already reimbursed medical device
The World After FDA Clearance: From HOORAY! To WAIT, WHAT?
Published on: 20/08/2024
FDA clearance is a milestone—not the finish line. Why reimbursement hurdles follow right after.
FDAPayer ExpectationsMedicarePayment ReadinessCommercial
