Qui Tam Quarterly: Enforcement Trends in False Claims Act Liability for Patient Assistance Programs

Patient assistance programs (“PAPs”) provide financial assistance to patients of limited financial means in a variety of forms, including free or discounted products, product coupons, cost-sharing assistance, and, in some cases, financial support to pay health insurance premiums, cost of living expenses, and travel reimbursement related to the receipt of medical care. Independent charitable organizations or foundations bolstered by donations from drug and medical device manufacturers generally administer these programs pursuant to the Health and Human Services Office of Inspector General’s guidance. However, in recent years, federal and state regulators have subjected PAPs to intense scrutiny and increased enforcement, particularly those programs that assist patients with drug costs.

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