
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:
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​Market Access / reimbursement strategies, considerations, timelines, etc. (product medical policy / Medicare Local Coverage Determination / payor coverage)
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Coding (AMA CPT, PLA, MAAA, MolDX Z, WHO ICD-10 codes, etc.)
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Reimbursement (Clinical Lab Fee Schedule/CMS)
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FDA regulatory pathways, considerations, processes, and timelines
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Impact of recent legislative initiatives on the molecular diagnostic and medical device markets
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Commercial insurance / payor perspective on evidence development, addressing unmet needs, and processes in support of favorable medical policy coverage
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Business development, legal, and fund-raising considerations
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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
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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!