A ground-breaking medical device, although recognized by major clinical compendia, was lacking the appropriate Current Procedural Terminology (CPT) codes. This created hesitancy among providers, who feared they would not be reimbursed or prescribing this supportive care technology for their patients.
To ensure broad access for their supportive care technology, a European-based medical device company looking to enter the US market sought guidance and support in understanding the US payer system and how to gain buy-in from US healthcare providers.
A clinical-stage pharmaceutical company faced a unique barrier in bringing its ﬁrst product to market—seeking pan-tumor approval based on a genetic marker, rather than a traditional approval based on cancer type. They subsequently sought recognition for the product across relevant clinical compendia.