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Thu, Apr 18


Barcelona, Spain

Coming to America

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

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Time & Location

Apr 18, 2024, 8:30 AM GMT+2 – Apr 19, 2024, 12:00 PM GMT+2

Barcelona, Spain

About the event

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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