Congress·In Committee·H.R. 5509

Congress Proposes New Rules to Help Patients Skip Insurance "Step Therapy" for Medications

Safe Step Act

6 months ago·View on Congress.gov

Part of: New Federal Bill Aims to Fast-Track Step Therapy Exception Requests

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Stalled

No legislative action in over 90 days.

↔Companion bill: Congress Proposes New Rules to Help Patients Skip Insurance 'Fail-First' Drug Requirements

Legislative Progress

House

Senate

President

Law

Key Points

This bill requires health insurance companies to create a clear and fast way for patients to skip "step therapy." Step therapy is a rule where an insurance company makes you try a cheaper or different medicine first and "fail" on it before they will pay for the one your doctor originally prescribed.
Patients and doctors can request an exception if the insurance company's preferred drug is likely to cause a bad reaction, if the patient is already doing well on a different medicine, or if waiting to try a different drug would be dangerous. This ensures patients get the right treatment without unnecessary delays.
Insurance companies would be required to respond to these requests quickly. For most cases, they must give an answer within 72 hours. In emergencies where a delay could seriously hurt the patient's health, the company must respond within 24 hours.
If an exception is granted, the insurance company must continue to cover that specific medication for at least one year. This prevents patients from having to repeat the request process every few months for the same condition.
To make sure the law is working, health plans will have to report data to the government every year. They must share how many requests they approved or denied and the reasons for those decisions. This information will be made public so people can see how insurance companies are handling these cases.

HealthcareLabor Employment

Impact Analysis

Personal Impact

Who is affectedScoreImpactCertaintyScopeDurationSentiment

Scores: 1 = low, 5 = highSentiment: -5 to +5 (net benefit)

Milestones

2 milestones2 actions

Sep 19, 2025House

Referred to the House Committee on Education and Workforce.

Sep 19, 2025

Introduced in House

Related News

5 articles

Healio·5 months ago

Congress reintroduces Safe Step Act to amend step therapy policies

In September 2025, members of the U.S. House and Senate reintroduced the Safe Step Act, requiring group health insurance plans to offer a timely exceptions process for 'fail-first' protocols. The bill aims to protect patients from delays in treatment that can worsen chronic conditions.

Dermatology Times·3 months ago

Safe Step Act Supports Timely Access to Essential Therapy

The Safe Step Act, a bipartisan federal bill establishing guardrails for step therapy, represents a potential turning point for clinicians and patients. By codifying timely exception processes and promoting transparency, the legislation aims to align insurer protocols with clinical judgment.

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Bio.News·4 months ago

Oncologist warns PBM step therapy has 'crossed a dangerous line'

An oncologist highlights how step therapy enforced by PBMs prevents timely access to essential medicines. The article discusses the reintroduction of the Safe Step Act on Sept. 19, 2025, as a critical measure to allow exceptions when alternative treatments could cause harm or delay care.

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