ACOI

Organizations Request Step Therapy Impact Study

by ACOI

August 18, 2025

ACOI has joined nearly 60 organizations on a letter to the U.S. Department of Health and Human Services Office of the Inspector General (OIG) requesting a study and report on the impacts of step therapy by Medicare Advantage (MA) plans for Part B drugs on Medicare beneficiary access to care. In 2018, the Department issued a memo which allowed MA plans to use step therapy for Part B drugs as of January 1, 2019.  

Because the use of step therapy, also referred to as “fail first,” has increased significantly since the guidance was issued, as well as MA enrollment, the letter asks for research to assess whether step therapy protocols are leading to disparate access to covered Part B drugs and medically necessary care.  

The letter provides examples of different permutations of step therapy requirements and noted the limited success organizations have had in convincing health plans to revise harmful step therapy policies, making evaluation of current Medicare policy an imperative next step.   

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