Avoiding the Patient Assistance Program Spotlight
In efforts to understand the rising cost of some drugs, Patient Assistance programs, particularly independent foundations, have become a focus of government investigations. This article explains what PAPs are, why they may be viewed as suspect and provides tips for providing patient assistance in a compliant manner.
While Patient Assistance Programs (“PAPs”) have existed for many years, lately, industry support of PAPs has come under increased government scrutiny. Before 2013, PAPs were under the radar as the government focused its Anti-Kickback Statute (“AKS”) violation investigations on hospitals and physicians.
The continuing drug pricing controversy has shifted the focus of AKS investigations, spurred by the proposed correlation between drug prices and donations to PAPs. Recently, PAPs have become a target of both the United States Department of Justice (“DOJ”) and the Department of Health and Human Services Officer of the Inspector General (“OIG”).