US Federal 2025-2026 Regular Session

US Federal House Bill HB5509

Introduced
 
Introduced
9/19/25  

Caption

Safe Step Act

Impact

The implementation of HB5509 would significantly alter how health plans handle requests for medication step therapy exceptions. By instituting clear timelines for responses, including expedited reviews in cases where life or health is at risk, the law is intended to protect patient interests and ensure access to necessary medications without unnecessary delays. If enacted, the bill would require plans to report on exception requests and outcomes, fostering accountability and transparency in how these protocols are managed.

Summary

House Bill 5509, known as the Safe Step Act, seeks to amend the Employee Retirement Income Security Act of 1974 by instituting a mandatory exceptions process for group health plans and health insurance issuers regarding medication step therapy protocols. The bill requires that if a health plan necessitates a patient to try a preferred drug before covering a prescribed non-preferred drug, the patient or their healthcare provider must have the ability to request an exception. This process aims to provide a fair and transparent avenue for patients who might face adverse effects or ineffectiveness from first-line treatments.

Contention

Despite its intentions, the Safe Step Act is not without contention. Critics may argue that the added requirements for plans could potentially lead to increased administrative burdens and costs for insurance companies. Furthermore, there could be disagreements regarding how effectively these exceptions are handled in practice, with potential concerns about delays in care or inadequate coverage of requests. Supporters, on the other hand, contend that these measures ensure patients receive the most appropriate treatment without arbitrary barriers that could jeopardize their health.

Companion Bills

US SB2903

Same As Safe Step Act

Previously Filed As

US SB2903

Safe Step Act

US SB307

AN ACT relating to step therapy protocols.

US S0264

Step-therapy Protocols

US SB668

SAFE STEPS for Veterans Act of 2025 Supporting Access to Falls Education and Prevention and Strengthening Training Efforts and Promoting Safety Initiatives for Veterans Act of 2025

US SB2010

Health insurance; require health benefit plans to follow new procedure related to step therapy protocol for CRF-COPD treatment.

US SB2069

Health insurance; require health benefit plans to follow new procedure related to step therapy protocol for CRF-COPD treatment.

US SB1064

Health insurance; establishing guidelines for step therapy protocol. Effective date,

US SB1064

Health insurance; establishing guidelines for step therapy protocol. Effective date,

US S2468

Limits the use by insurers of step therapy, a protocol that establishes a specific sequence in which prescription drugs for a specified medical condition are covered by an insurer, by allowing medical providers to request step therapy exceptions.

US H7539

Limits the use by insurers of step therapy, a protocol that establishes a specific sequence in which prescription drugs for a specified medical condition are covered by an insurer, by allowing medical providers to request step therapy exceptions.

Similar Bills

MS SB2069

Health insurance; require health benefit plans to follow new procedure related to step therapy protocol for CRF-COPD treatment.

MS SB2010

Health insurance; require health benefit plans to follow new procedure related to step therapy protocol for CRF-COPD treatment.

US SB2903

Safe Step Act

CA AB543

Medi-Cal: field medicine.

LA SB221

Provides relative to ambulance providers. (8/1/26) (EN NO IMPACT See Note)

CA AB2335

Unclaimed property: digital financial assets.

AR SB444

To Amend The Medical Ethics And Diversity Act.

NY A09169

Enacts the New York-Dominican health partnership act; establishes a commission to study and develop a framework for authorizing New York state-funded health services for eligible seniors and individuals with disabilities residing part-time in the Dominican Republic through a pilot partnership with the Seguro Nacional de Salud (SeNaSa), the primary public health insurer of the Dominican Republic and explores overall bilateral health collaboration between the state of New York and the Dominican Republic.