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Coming to America - Supporting the Success of European Diagnostics Companies through Best Practices with Market Access, Regulatory and Business/Legal

Event Overview

Join us in Barcelona, Spain for an exclusive event on commercializing your diagnostic product in the US market from some of the leading experts in the industry:


  • ​Market Access / reimbursement strategies, considerations, timelines, etc. (product medical policy / Medicare Local Coverage Determination / payor coverage)

  • Coding (AMA CPT, PLA, MAAA, MolDX Z, WHO ICD-10 codes, etc.)

  • Reimbursement (Clinical Lab Fee Schedule/CMS)

  • FDA regulatory pathways, considerations, processes, and timelines

  • Impact of recent legislative initiatives on the molecular diagnostic and medical device markets

  • Commercial insurance / payor perspective on evidence development, addressing unmet needs, and processes in support of favorable medical policy coverage

  • Business development, legal, and fund-raising considerations

  • CLIA lab development in the US market (where to establish based on payor sources (e.g., MolDX / Medicare jurisdictions), tax implications, validation nuances and LDT vs. IVD considerations

  • End of meeting panel discussion


​Please enter your contact information and we will keep you posted on the venue. We look forward to seeing you in Spain!

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