HR 5509119th CongressIn Committee

Safe Step Act

Introduced: Sep 19, 2025

Sponsor: Rep. Allen, Rick W. [R-GA-12] (R-Georgia)

Healthcare

Standard Summary

Comprehensive overview in 1-2 paragraphs

The Safe Step Act would amend the Employee Retirement Income Security Act of 1974 (ERISA) to require group health plans and health insurance coverage that use medication step therapy protocols to establish a formal exceptions process. Under the bill, a participant, beneficiary, or their prescriber can request an exception to the step-therapy requirement, and if the request meets defined criteria, the plan must cover the requested medication at the plan’s standard cost-sharing for at least one year. The process must be clear, timely, and capable of handling urgent cases, with specific criteria for when an exception should be approved. The bill also requires annual reporting to the Secretary of Labor (and related oversight by Congress) on step-therapy exception requests, outcomes, and related information, and it imposes data-access requirements on plans’ PBMs/TPAs. The act would take effect for plan years beginning at least six months after enactment, with final regulations due within six months of enactment. In essence, the bill is designed to curb barriers created by step-therapy (also known as “prior authorization” or “fail-first” requirements) by guaranteeing a formal, timely path to obtain an exception when clinically appropriate, while increasing transparency and data reporting on how step therapy is used.

Key Points

1Establishes a new ERISA provision (SEC. 713A) requiring a mandatory exceptions process for medication step therapy protocols in group health plans and associated prescription drug coverage.
2Defines clear, enumerated criteria for when an exception can be approved, including prior treatment failure, potential harm if delayed, contraindications, functional impairment, prior plan approvals, and other Secretary-approved circumstances.
3Requires a transparent, prescriber- or patient-friendly process (forms, submission methods, ability to present clinical rationale, and expedited review for urgent cases) and ensures that approved exceptions are covered at the plan’s standard cost-sharing for at least one year.
4Allows expedited determinations in urgent situations (as fast as 24 hours if no additional information is needed; otherwise within 24 hours after receipt of required information, with base determinations within 72 hours in non-urgent cases).
5Adds annual reporting to the Secretary (and a Congress-facing summary) on the number and outcomes of step-therapy exception requests, appeals, the circumstances involved, and PBM/TPA information, plus a prohibition on contracting practices that block data necessary for reporting.

Impact Areas

Primary group/area affected- Participants and beneficiaries in employer-sponsored group health plans and their prescription drug coverage, as well as their prescribing cliniciansSecondary group/area affected- Plan sponsors and health insurers offering group health coverage; health plan administrators and pharmacy benefit managers (PBMs) that support coverage decisionsAdditional impacts- Providers (physicians, nurses, physician assistants) who submit exception requests and may engage in expedited reviews for urgent cases- Federal regulators (Department of Labor, potentially Department of Health and Human Services) responsible for rulemaking and oversight- Researchers and policymakers through annual reporting to Congress and public release of trend data- Potential impacts on plan design, administrative costs, and drug pricing/patient access dynamics depending on how plans implement the new process and respond to reporting requirementsThe bill labels the measure the “Safe Step Act” and sets an effective date for plan years beginning at least six months after enactment, with final regulations due within six months of enactment.It applies to any policy meeting the definition of a medication step therapy protocol, regardless of labeling by the plan.

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