OIG Issues Favorable Advisory Opinion to Pharmaceutical Manufacturer on Direct-to-Patient Discount Sales Program

On July 28, 2014, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued a favorable opinion concerning a drug manufacturer’s program to offer a certain branded drug via an online, mail order pharmacy directly to cash-paying customers at a discounted price. In Advisory Opinion 14-05, the OIG concludes that, while aspects of the proposed arrangement implicate the Anti-Kickback Statute (AKS), certain outlined safeguards provide OIG comfort with the proposed arrangement such that the OIG will not impose administrative sanctions on the manufacturer or pharmacy.

* This article was originally published in the Health Care Counsel blog. To read it in its entirety, click here.