Safe Step Act
- Sponsor
- Sen. Murkowski, Lisa [R-AK]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Mar 19, 2026
Bottom line
The Safe Step Act aims to provide patients and their prescribers with a clear and timely pathway to override 'step therapy' requirements imposed by health plans, ensuring access to medically necessary prescription drugs without undue delay.
What it actually does
This bill amends the Employee Retirement Income Security Act of 1974 (ERISA) to mandate that group health plans and health insurance issuers offering coverage in connection with such plans implement a clear, prompt, and transparent exceptions process for medication step therapy protocols. It specifies six circumstances under which an exception must be granted, establishes strict timelines for review, and requires annual reporting to the Secretary of Labor on exception requests and outcomes.
Proponents argue
Supporters argue that step therapy protocols, while intended to control costs, often delay or deny patients access to the most effective treatments, leading to worse health outcomes, increased suffering, and higher long-term healthcare costs. They contend this bill empowers healthcare providers to make timely, patient-centered decisions, improving patient care and reducing administrative burdens.
Opponents contend
Opponents, typically health plans and pharmacy benefit managers (PBMs), argue that step therapy protocols are a crucial tool for managing prescription drug costs, promoting the use of clinically appropriate and cost-effective medications, and preventing waste. They might contend that this bill could undermine cost-containment efforts, increase healthcare premiums, and potentially lead to the overuse of more expensive drugs.
The bill is concise and clearly written, making it accessible for a quick but thorough review by an informed reader.
Section 2(a), adding new Section 713A(a) to ERISA
Mandate for a Clear, Prompt, and Transparent Exception Process
This provision requires all group health plans and health insurance issuers that use medication step therapy protocols to create a clear, fast, and open process for patients or their doctors to request an exception to these protocols. If the exception criteria are met, the plan must cover the requested drug in accordance with the standard patient cost-sharing rates.
Supporters argue
Supporters argue this process is essential to ensure patients receive timely, medically appropriate care, preventing delays that can worsen health conditions and increase overall healthcare costs. It respects the clinical judgment of prescribers.
Critics contend
Opponents may argue that creating and managing such an exceptions process adds significant administrative overhead and could lead to an increase in approvals for more expensive drugs, thereby driving up premiums for all beneficiaries.
Tradeoffs
Balances patient access to specific medications and prescriber autonomy against health plan cost-containment strategies and administrative efficiency.
Section 2(a), adding new Section 713A(b) to ERISA
Specific Criteria for Granting Step Therapy Exceptions
This section details six specific situations where a health plan must grant an exception to a step therapy protocol. These include when required treatments have been ineffective, when delay would cause severe or irreversible consequences, when treatments are contraindicated, when they prevent functional ability, when a patient is stable on a previously approved drug, or other circumstances determined by the Secretary.
Section 2(a), adding new Section 713A(c) to ERISA
Standardization and Transparency of the Exception Request Process
This provision mandates that the exception process must allow prescribers or patients to present clinical rationale, use standard paper and electronic forms, provide clear criteria for approval, and only require strictly necessary information. It also requires plans to outline conditions for expedited review and allow third-party advocates. Information about this process must be readily available.
Section 2(a), adding new Section 713A(d) to ERISA
Expedited Review Timelines for Exception Requests
This provision sets strict deadlines for health plans to respond to exception requests. For standard requests, a determination or request for more information must be made within 72 hours, with a final determination within 72 hours of receiving all information. For urgent cases where delay could jeopardize life, health, function, or cause severe pain, the initial determination must be within 24 hours, and the final determination also within 24 hours of receiving all necessary information.
Section 2(a), adding new Section 713A(e) to ERISA
Minimum One-Year Duration for Approved Exceptions
Once an exception to a medication step therapy protocol is granted, this provision ensures that coverage for the approved drug remains in effect with respect to that participant or beneficiary for at least one year.
Section 2(a), adding new Section 713A(h) to ERISA
Data Collection and Public Reporting on Step Therapy Exceptions
This provision requires group health plans and issuers to report annually to the Secretary of Labor on the number of step therapy exception requests received, approved, denied (with reasons), appealed, and reversed, broken down by exception circumstance. It also requires reporting on requests for additional information, who submitted requests, medical conditions, and entities providing pharmacy benefit management services. The Secretary must then submit a summary and analysis of this data to Congress and make it publicly available. Plans cannot contractually prevent PBMs from providing this data.
This subsection clarifies that the requirements of the new section apply to any policy that meets the definition of 'medication step therapy protocol,' regardless of what the group health plan or health insurance coverage calls such a policy.
Section 2(a), adding new Section 713A(g) to ERISA
Why it matters:This is standard legislative practice to prevent circumvention of the law through semantic reclassification.
Case for: Supporters would argue this prevents health plans from simply renaming their step therapy programs to avoid compliance with the new exception requirements, ensuring the law's intent is fully realized.
Case against: No specific opposition is typically raised against such anti-circumvention language, as it aims to uphold the spirit of the law.
Estimated impact: Ensures broad applicability of the new exception process, preventing loopholes.
This provision prohibits group health plans or health insurance issuers from entering into contracts with third-party administrators or pharmacy benefit management (PBM) services that prevent the plan or issuer from obtaining the information needed to comply with the new reporting requirements.
Section 2(a), adding new Section 713A(h)(2) to ERISA
Why it matters:This is a crucial enforcement mechanism, preventing PBMs from using contractual clauses to shield data necessary for oversight. It's technically phrased but has significant implications for transparency.
Case for: Proponents argue this is vital to ensure the reporting requirements are enforceable and that PBMs, who often manage these protocols, cannot hide data from public scrutiny or regulatory oversight.
Case against: PBMs might privately object, as it limits their contractual autonomy and exposes data they might prefer to keep proprietary, though they are unlikely to publicly oppose anti-circumvention measures.
Estimated impact: Significantly enhances the enforceability and transparency of the reporting requirements.