Safe Step Act
Sponsored By: Senator Lisa Murkowski
Introduced
Summary
Creates a mandatory, transparent exceptions process for medication step therapy so patients and prescribers can quickly request coverage of a non-preferred drug when medically needed. The bill sets timelines, standard forms, and public notice rules to make exception requests faster and clearer.
Show full summary
- Patients and prescribers would get a clear path to request exceptions, submit clinical rationale on a standard paper or electronic form, and designate a third-party advocate. Plans must respond within 72 hours for routine requests and within 24 hours for emergencies, and granted exceptions must remain covered for at least one year.
- Group health plans and insurers would have to publish the process, forms, required supporting information, and contact details on plan materials and websites. The bill limits information requests to what is strictly necessary and stops pharmacy benefit managers or third-party administrators from withholding data needed for reporting.
- Plans would report counts and outcomes of exception requests by circumstance, specialty, and condition starting not later than three years after enactment and each year thereafter by October 1. The Secretary of Labor would compile a Congressional summary of trends, and the Secretary must issue final implementing regulations within six months with the rule applying to plan years that begin at least six months after enactment.
Bill Overview
Analyzed Economic Effects
6 provisions identified: 6 benefits, 0 costs, 0 mixed.
Clear drug exception process
This bill would require employer group health plans that use step therapy to have a clear, quick exception process. You, your doctor, or a chosen representative could request an exception using a standard form. Plans would have to publish the form, instructions, and contact information in plan materials and on plan websites.
Faster decisions for drug exceptions
This bill would require plans to answer routine exception requests within 72 hours. If a plan asks for more needed information, it must decide within 72 hours after getting it. For urgent cases that could risk life, health, major function, or severe pain, plans would have 24 hours to decide.
Guaranteed coverage after an exception
If a plan grants an exception, this bill would require the plan to cover the drug under the plan's cost-sharing terms in effect at the plan year's start. Coverage under the exception would have to last at least one year for that person.
When exceptions must be approved
This bill would list six reasons a plan must approve a step-therapy exception. Examples include when required drugs already failed, are contraindicated, would seriously harm health or function, or when a patient is stable on the prescribed drug. The Secretary could add other reasons.
Annual reports on step-therapy requests
This bill would make group plans report counts of exception requests and outcomes to the Secretary. The first report would be due within three years of enactment, then every year by October 1. Plans could not sign contracts that block the data needed for these reports.
Labor must write final rules
This bill would require the Labor Department to issue final rules to implement the exceptions process within six months of enactment. The rules would go through public notice-and-comment rulemaking to guide plans and issuers.
Sponsors & CoSponsors
Sponsor
Lisa Murkowski
AK • R
Cosponsors
Maggie Hassan
NH • D
Sponsored 9/18/2025
Roger Marshall
KS • R
Sponsored 9/18/2025
Jacky Rosen
NV • D
Sponsored 9/18/2025
Alex Padilla
CA • D
Sponsored 9/18/2025
John Hickenlooper
CO • D
Sponsored 9/18/2025
Jeff Merkley
OR • D
Sponsored 9/18/2025
Dan Sullivan
AK • R
Sponsored 9/18/2025
Raphael Warnock
GA • D
Sponsored 9/18/2025
Cindy Hyde-Smith
MS • R
Sponsored 9/18/2025
Catherine Cortez Masto
NV • D
Sponsored 9/18/2025
Jerry Moran
KS • R
Sponsored 9/18/2025
Kevin Cramer
ND • R
Sponsored 9/18/2025
Timothy Kaine
VA • D
Sponsored 9/18/2025
Ted Budd
NC • R
Sponsored 9/18/2025
Jeanne Shaheen
NH • D
Sponsored 9/18/2025
Cory Booker
NJ • D
Sponsored 9/18/2025
Ron Wyden
OR • D
Sponsored 9/18/2025
Christopher Coons
DE • D
Sponsored 9/18/2025
Richard Blumenthal
CT • D
Sponsored 10/1/2025
John Boozman
AR • R
Sponsored 10/1/2025
Kirsten Gillibrand
NY • D
Sponsored 10/1/2025
Thomas Tillis
NC • R
Sponsored 10/7/2025
Martin Heinrich
NM • D
Sponsored 10/7/2025
Amy Klobuchar
MN • D
Sponsored 10/7/2025
Chris Van Hollen
MD • D
Sponsored 10/21/2025
Adam Schiff
CA • D
Sponsored 10/23/2025
Mark Kelly
AZ • D
Sponsored 10/23/2025
Deb Fischer
NE • R
Sponsored 10/27/2025
Gary Peters
MI • D
Sponsored 11/19/2025
Tammy Duckworth
IL • D
Sponsored 12/4/2025
Jon Ossoff
GA • D
Sponsored 12/9/2025
Tina Smith
MN • D
Sponsored 12/16/2025
Susan Collins
ME • R
Sponsored 2/12/2026
Roll Call Votes
No roll call votes available for this bill.
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