As Prescribed

Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose medications are typically costly, such that even affording copay or coinsurance payments can be a prohibitive challenge. However, for various reasons, PAPs have come under intense scrutiny from the US Department of Health and Human Services Office of Inspector General (HHS OIG) under theories that the subject programs run afoul of, among others, the anti-kickback statute, and civil monetary penalties laws, which expressly prohibit any person from offering or transferring anything of value to a government beneficiary that the person knows or should have known is likely to influence a beneficiary’s selection of a particular provider, practitioner, or supplier.