In a recent Special Advisory Bulletin and a separate report, the Office of Inspector General (OIG) emphasized the Anti-Kickback Statute risks for manufacturers that offer coupons to reduce or eliminate co-payments for brand-name drugs (co-payment coupons). The OIG explained that the Anti-Kickback Statute is implicated when co-payment coupons are used for drugs reimbursable by Medicare Part D or another federal health care program. Further, the OIG found that current safeguards are inadequate to prevent such coupons from being used for Medicare Part D drugs. The Special Advisory Bulletin and report were concurrently released in September.

Special Advisory Bulletin

The Special Advisory Bulletin addressed the Anti-Kickback Statute implications of pharmaceutical manufacturer co-payment coupons and the significance of cost-sharing for federal health program drugs. Co-payment coupons are any form of direct support offered by manufacturers to insured patients that reduce or eliminate immediate out-of-pocket costs for specific prescription medication.

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