Co-Pay Accumulator Programs Await Further Guidance

In April 2019 the U.S. Department of Health and Human Services ("HHS") issued regulations addressing whether the amount of financial support provided by drug manufacturers, such as co-pay assistance coupons, must be counted toward the annual cost-sharing limits under the Patient Protection and Affordable Care Act (the "ACA"). HHS was concerned that drug manufacturers' cost-sharing support increased the cost of prescription drugs and encouraged patients to use higher-cost brand name drugs instead of less expensive generic drugs. Accordingly, under the new regulation, amounts individuals pay toward cost-sharing using support provided by a drug manufacturer (e.g., a co-pay coupon) to reduce or eliminate their out-of-pocket costs for certain brand-name prescription drugs are generally not required to be counted toward the annual cost-sharing limits under the ACA. To qualify for this treatment, a brand-name prescription drug must have a generic equivalent that is available