72 Fla. L. Rev. 639 (2020)
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Governments and Legislation


Largely funded by the pharmaceutical industry, Independent Charity
Patient Assistance Programs (PAPs) dispense billions of dollars of aid
annually to help financially vulnerable patients afford their prescription
drugs. Recently, these charitable entities and their drug company donors
have faced mounting legal scrutiny for allegedly funneling illegal
kickbacks to Medicare beneficiaries. This Note examines Independent
Charity PAPs and the issues they raise under the Anti-Kickback Statute
(AKS). It explores the uncertain legal environment in which Independent
Charity PAPs operate and concludes that a new AKS regulatory safe
harbor may be necessary to preserve the viability of the safety net
assistance that Independent Charity PAPs provide.