Eric and Sean tackle the world of FDA Devices and Biologics and address the fact that on June 1, 2021, manufacturers of cell and gene therapy HCT/Ps that do not hold an approved marketing application or fall within one of the two exempt categories are operating at risk of violating the PHS Act and/or FD&C Act.

What does it mean to have an “Approved HCPCS Code” vs an actual coverage policy and how do providers and clinics mitigate their risk when vendors provide less than accurate information regarding the coding and billing of services…?