Step therapy (also known as "fail first") is a policy used by health insurers that require patients to try and fail one or more formulary-covered medications before providing coverage for the originally prescribed non-formulary or non-preferred medication. Insurers implement this policy to control formulary access for the highest rebated drugs, which provides a bigger profit for the insurer and PBM with very little consideration for efficacy.
Step therapy can lead to serious negative patient outcomes. Some patients are required to try up to 5 different medications with durations lasting up to 130 days per medication. This practice inhibits physicians from being able to provide individualized care, can sacrifice valuable treatment time, and may cause patients to suffer unnecessarily. Also, step therapy can lead to increased costs for patients if it is not carefully managed.
CSRO supports policies that establish commonsense reforms that prevent insurance companies from abusive step therapy practices that prevent patients from accessing the medications they need. This includes legislation that requires step therapy protocols to be based on clinical practice guidelines and establish step therapy exceptions processes.
CSRO is the Immediate Past Chair of the State Access to Innovative Medicine (SAIM) Coalition, which is responsible for the creation of the step therapy reform model language. Each year, CSRO commits resources to state efforts through both SAIM and to its state society members to educate and advocate in support of step therapy reform. This includes providing committee testimony, submitting letters of support, attending advocacy days, placing op-eds and social media posts, and sending out action alerts for members to send their own letters to elected officials.
At the federal level, CSRO supports the Safe Step Act, which would require employer-sponsored plans to establish commonsense reforms that prevent insurance companies from abusive step therapy practices that prevent patients from accessing the medications they need. The legislation codifies exceptions to step therapy in five specific circumstances and creates a regulatory process for the agency to add additional circumstances in the future.
CSRO coordinates advocacy efforts with several coalitions in support of the Safe Step Act, including the Alliance of Specialty Medicine and the Safe Step Act Coalition.
Visit our Legislative Map Tool to read about current step therapy laws or legislation in your state. You can send letters in support of pending legislation and find educational materials.
