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.
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.