Patient Assistance Programs and the Anti-Kickback Statute: Charting a Pathway Forward
In the US health care system, as millions of patients remain uninsured and many more experience substantial cost exposures through deductibles, coinsurance, and co-payments,1 some have turned to patient assistance programs for help in paying for expensive prescription drugs. Patient assistance programs provide subsidies that allow patients to meet their out-of-pocket payment obligations when filling prescriptions for expensive drugs. Although patient assistance programs are generally nonprofit entities, they often receive substantial support from pharmaceutical manufacturers.2 These programs work by either acquiring and providing drugs at little or no cost to patients or by providing subsidies (including coupons) that offset patient out-of-pocket costs for drugs that are reimbursed by insurers. The latter approach raises broader policy and legal questions, especially where public insurers, like Medicare, are involved.3,4