Do patients benefit from legislation regulating step therapy?

Abstract

Step therapy, also termed fail-first policy, describes a practice of insurance and pharmacy benefit management companies denying reimbursement for a specific treatment until after other treatments have first been found ineffective (i.e. failed). Laws to limit step therapy have been passed in 29 states of the United States. Using extrapolated data on fully insured employees, we find that except for New York and New Mexico, enacted State laws don't apply to even one-third of a state's population. Using the more robust Kaiser Family Foundation (KFF) data, which do not include fully insured employees, we find that only 2-10% of a state's population is covered. Advocating for these laws has been an expensive and time-consuming process, likely to become more so for the 21 states without such laws. The laws that have been enacted can be near impossible, to enforce, and loopholes exist. As a result, using KFF data, more than 90% of people in the United States with health insurance may still be unable to access the treatment chosen as most appropriate for them with their physician. Based on these data, we conclude federal step-therapy legislation is needed.

Keywords: Fail-first policy; insurance company policy; legislation; patient advocacy; patient-centered outcomes; pharmacy benefit management; reimbursement; safe step act; step therapy.