On March 18, the Office of Inspector General (OIG) issued a
favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy (Product) providing the Product to qualified patients (Program), including patients insured under state or federal healthcare programs. In issuing its Opinion, the OIG relied on many of the same factors it relied upon in Advisory Opinions 20-05, 18-14, and 15-11. These key factors include risks associated with seeding, overutilization, influencing patients to select a certain provider or practitioner, and providing benefits to the prescriber. Because the Product is administered in specified healthcare facilities, the Opinion does not address risks for pharmacies administering free drug programs.