CMS Finalizes Guidance on Pharmaceutical Coupons and Cost Sharing

On Thursday, May 7, 2020, the United States Centers for Medicare and Medicaid Services (CMS) released the 2021 Notice of Benefit and Payment Parameters final rule. This rule finalizes the CMS’ proposed modification of existing policy relating to how pharmaceutical manufacturer direct assistance (i.e., coupons) accrues with respect to health plan enrollees’ annual limit on cost sharing.

Background

Under the Final 2020 Payment Rule (the prior Rule), CMS allowed insurers to exclude coupons from an enrollee’s annual limit on out-of-pocket costs in certain circumstances – including if the plan covered a medically appropriate and available generic equivalent. Such an exclusion