OIG bulletin on DTC and AKS

HHS’s Office of the Inspector General has issued a new advisory bulletin about pharma manufacturers selling medications directly to consumers. The gist? “[T]here is a low risk that a manufacturer would violate the Federal anti-kickback statute.” Of course, low risk doesn’t mean no risk, and there are cases when a manufacturer’s program would run afoul of the law. “Because DTC programs have only recently begun to proliferate,” the bulletin says, “it is impossible to predict the ways in which abuse may occur.”