The healthcare regulation and reimbursement landscape in the US is fraught with complexities. Lengthy processes and nuanced pathways mean companies seeking to enter the US face significant hurdles to bring their technology to market.
The onset of the Covid-19 pandemic has only added to these challenges. Companies seeking to enter this industry must not only understand the challenges relating to market entry, but also how to navigate this landscape and develop a strategy for long-term success.
In this webinar we will:
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Gain a better understanding of the US regulatory and reimbursement challenges within the healthcare industry
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Outline and discuss issues regarding access to the US market
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Identify and discuss the nuances between FDA regulatory processes and EUA authorization pathways
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Recognize the regulatory requirements for digital-health/tele-health products in the US
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Discuss the process regarding evidence generation for FDA submissions, payment, and purchasing decisions
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Develop effective strategies for a pre-submission meeting with the FDA
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Consider all major aspects of healthcare coding, billing, and reimbursement
