ACOI

ACOI Joins Coalition in Asking for Step Therapy Regulations

by ACOI

June 16, 2026

The ACOI has joined more than 100 organizations are part of the Safe Step Ad Hoc Coalition in a letter asking the Centers for Medicare and Medicaid Services (CMS) to undertake rulemaking to create common-sense guardrails on the use of step therapy, or "fail-first," processes, including if the patient already tried the insurer’s preferred drug, and it has failed or is reasonably expected to be ineffective.

The letter is in response to a request from information from CMS on whether increased interoperability of information technology systems across payers could be used to make utilization management policies, such as step therapy, more transparent. The Coalition asked for standardization in the step-therapy exceptions process across payers, including requiring plans to provide clinical rationales and other supporting evidence for all step therapy protocols.

Legislation is also pending in Congress that would require exceptions to step-therapy processes used by self-insured plans governed by the Employee Retirement Income Security Act (ERISA). ACOI members can speak up in favor of the legislation — the Safe Step Act (S. 2903 / H.R. 5509) — by contacting their members of Congress through the ACOI Action Center.

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