Safe Step Act
- Sponsor
- Rep. Allen, Rick W. [R-GA-12]
- Committees
- Education and Workforce Committee (primary)
- Last action
- Sep 19, 2025
Bottom line
The Safe Step Act aims to protect patients by ensuring they can bypass step therapy requirements when medically necessary, preventing delays in accessing appropriate prescription drugs.
What it actually does
This bill amends the Employee Retirement Income Security Act of 1974 (ERISA) to require group health plans and health insurance coverage offered in connection with such plans to implement a clear, prompt, and transparent exceptions process for medication step therapy protocols. It specifies six circumstances under which an exception must be granted, sets strict timelines for determinations, and mandates annual reporting on exception requests to the Secretary of Labor.
Proponents argue
Supporters argue that step therapy protocols, while intended to control costs, often delay or deny patients access to the most effective medications, leading to worsened health outcomes, increased suffering, and potentially higher long-term healthcare costs. This bill provides crucial patient protections by establishing a clear, prompt, and transparent exceptions process, empowering patients and their prescribers.
Opponents contend
Opponents, typically health plans and pharmacy benefit managers, contend that step therapy is an essential tool for managing prescription drug costs and promoting the use of clinically appropriate, cost-effective medications. They argue that broad exceptions could undermine cost-containment efforts, increase premiums for all plan participants, and potentially lead to less efficient healthcare spending.
The bill is concise and clearly written, making it accessible for a thorough review within a reasonable timeframe.
Section 2(a), new Section 713A(a) of ERISA
Mandate for Step Therapy Exception Process
This provision requires all group health plans and health insurance issuers to establish a clear, prompt, and transparent process. This process allows a participant, beneficiary, or their prescribing healthcare provider to request an exception to any medication step therapy protocol. If the request meets the specified criteria, the plan must cover the requested drug according to its standard cost-sharing terms.
Supporters argue
Supporters argue this provision empowers patients and providers, ensuring access to necessary medications without undue administrative burden or health risks, thereby prioritizing patient care.
Critics contend
Critics may argue this provision adds administrative complexity and costs to health plans, potentially undermining existing cost-containment strategies that rely on step therapy.
Tradeoffs
This provision balances patient access and provider autonomy against health plan cost management and administrative efficiency, aiming to find a middle ground.
Section 2(a), new Section 713A(b) of ERISA
Criteria for Granting Step Therapy Exceptions
This section outlines six specific conditions under which a health plan must grant an exception to a step therapy protocol. These conditions include situations where prior treatments were ineffective, delaying treatment would lead to severe consequences, the required treatment is contraindicated or likely to cause adverse reactions, the treatment prevents functional ability, the patient is stable on a previously approved drug, or other circumstances determined by the Secretary.
Section 2(a), new Section 713A(d) of ERISA
Expedited Review and Response Timelines
This provision establishes strict deadlines for health plans to respond to step therapy exception requests. For standard requests, a response is required within 72 hours, with an additional 72 hours after receiving any necessary additional information. For expedited requests, where a delay could seriously jeopardize a patient's life, health, or functional ability, the plan must respond within 24 hours.
Section 2(a), new Section 713A(h) of ERISA
Data Collection and Congressional Reporting
This provision mandates that group health plans and health insurance issuers annually report detailed data to the Secretary of Labor regarding step therapy exception requests. This data includes approval/denial rates, reasons for denials, appeals, and information on entities providing pharmacy benefit management services. The Secretary is then required to submit a summary and analysis of this data to Congress and make it publicly available.
These subsections define 'medication step therapy protocol' broadly to include any drug therapy utilization management protocol requiring a participant to try an alternative preferred drug before approving coverage for a non-preferred drug. Subsection (g) explicitly clarifies that the requirements of the section apply regardless of how a plan or issuer describes such a policy.
Section 2(a), new Section 713A(f) and (g) of ERISA
Why it matters:While standard legislative practice to define terms, the clarification in (g) is crucial to prevent circumvention of the bill's intent by health plans attempting to re-label their policies.
Case for: Supporters argue this broad definition and explicit clarification are essential to ensure the law applies comprehensively to all forms of step therapy, preventing health plans from using semantic distinctions to avoid compliance and ensuring consistent patient protections.
Case against: Health plans might argue this broad definition could inadvertently capture other legitimate utilization management tools, increasing compliance burden and potentially stifling innovation in cost-management strategies.
Estimated impact: Ensures broad applicability of the bill's protections across various plan designs and utilization management strategies, preventing loopholes.
This subsection prohibits group health plans or health insurance issuers from entering into contracts with third-party administrators or entities providing pharmacy benefit management (PBM) services that would prevent the plan or issuer from obtaining the information necessary to comply with the bill's reporting requirements.
Section 2(a), new Section 713A(h)(2) of ERISA
Why it matters:This is a critical enforcement mechanism for the reporting requirements, designed to address a known issue where PBM contracts can obscure data. Such technical enforcement provisions are often placed in detailed sections.
Case for: Proponents argue this provision is vital for transparency, ensuring that PBMs cannot hide data essential for oversight and accountability, thereby strengthening the effectiveness of the reporting mandate.
Case against: PBMs might argue this interferes with proprietary data or existing contractual agreements, potentially increasing their administrative burden and possibly impacting their ability to negotiate effectively, which they claim could lead to higher drug costs.
Estimated impact: Significantly increases transparency in PBM practices and strengthens the enforceability of the data reporting mandate, providing regulators with more comprehensive information.