Safe Step Act
Sponsored By: Senator Murkowski, Lisa [R-AK]
In Committee
Summary
A mandated exceptions process for medication step therapy would require ERISA-covered group health plans to give patients and prescribers a clear, prompt way to request coverage for non-preferred drugs, backed by strict timelines and public reporting.
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- Patients and families would get faster access when clinical reasons apply. Initial determinations must be made within 72 hours and expedited reviews for life-threatening or severe pain cases within 24 hours.
- Prescribers and patient advocates would use a standard paper or electronic form to submit clinical rationale and limited necessary records. Approved exceptions must stay in effect for at least one year.
- Plans, issuers, and pharmacy benefit managers must adopt transparent processes, limit information requests to what is necessary, and report step-therapy exception data to the Secretary of Labor within three years and then annually by October 1. Contracts may not block data sharing needed for reporting.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
Annual reporting on step therapy use
If enacted, each group health plan and issuer would report step‑therapy exception data to the Department of Labor starting no later than three years after enactment and then yearly by October 1. Reports would include counts of requests, outcomes (approved and denied with reasons), appeals and reversals, extra information requests, whether the participant or prescriber filed, medical conditions for adverse‑reaction exceptions, and which PBM or TPA provided services. The Secretary would publish an annual report to Congress summarizing this data.
Faster reviews and one-year coverage
If enacted, plans using step therapy would have to use a standard form and accept requests and extra information by paper or electronic means. Plans would have 72 hours to make an initial determination and 72 hours to issue a final decision after receiving any required additional information. Urgent, life‑threatening, or severe‑pain cases would be expedited to 24‑hour timing. If an exception is approved, coverage must follow the plan's cost‑sharing rules for that plan year and remain in effect for at least one year.
Medical reasons for step exceptions
If enacted, the bill would require plans to approve an exception when any of six medical circumstances apply. These include prior treatment failures, risk of severe or irreversible harm from delaying the requested drug, contraindications or likely adverse reactions, likely loss of reasonable and safe function, clinical stability with prior approval by any plan, or other reasons the Secretary finds appropriate. When one of these conditions is met, plans would have to treat the request as an exception under the statute.
Which plans count as step therapy
If enacted, this bill would apply to any group health plan or group health insurance that uses a medication step therapy protocol, no matter what the plan calls that policy. It would define a medication step therapy protocol as rules that make you try a preferred drug before covering a non-preferred drug. The rules would apply to plan years that begin at least six months after enactment, and the Secretary of Labor would have six months to issue final implementing rules.
Sponsors & CoSponsors
Sponsor
Murkowski, Lisa [R-AK]
AK • R
Cosponsors
Sen. Hassan, Margaret Wood [D-NH]
NH • D
Sponsored 9/18/2025
Sen. Marshall, Roger [R-KS]
KS • R
Sponsored 9/18/2025
Sen. Rosen, Jacky [D-NV]
NV • D
Sponsored 9/18/2025
Sen. Padilla, Alex [D-CA]
CA • D
Sponsored 9/18/2025
John Hickenlooper
CO • D
Sponsored 9/18/2025
Sen. Merkley, Jeff [D-OR]
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
Sen. Cortez Masto, Catherine [D-NV]
NV • D
Sponsored 9/18/2025
Sen. Moran, Jerry [R-KS]
KS • R
Sponsored 9/18/2025
Sen. Cramer, Kevin [R-ND]
ND • R
Sponsored 9/18/2025
Sen. Kaine, Tim [D-VA]
VA • D
Sponsored 9/18/2025
Sen. Budd, Ted [R-NC]
NC • R
Sponsored 9/18/2025
Sen. Shaheen, Jeanne [D-NH]
NH • D
Sponsored 9/18/2025
Sen. Booker, Cory A. [D-NJ]
NJ • D
Sponsored 9/18/2025
Sen. Wyden, Ron [D-OR]
OR • D
Sponsored 9/18/2025
Sen. Coons, Christopher A. [D-DE]
DE • D
Sponsored 9/18/2025
Sen. Blumenthal, Richard [D-CT]
CT • D
Sponsored 10/1/2025
John Boozman
AR • R
Sponsored 10/1/2025
Sen. Gillibrand, Kirsten E. [D-NY]
NY • D
Sponsored 10/1/2025
Sen. Tillis, Thomas [R-NC]
NC • R
Sponsored 10/7/2025
Sen. Heinrich, Martin [D-NM]
NM • D
Sponsored 10/7/2025
Amy Klobuchar
MN • D
Sponsored 10/7/2025
Sen. Van Hollen, Chris [D-MD]
MD • D
Sponsored 10/21/2025
Sen. Schiff, Adam B. [D-CA]
CA • D
Sponsored 10/23/2025
Sen. Kelly, Mark [D-AZ]
AZ • D
Sponsored 10/23/2025
Sen. Fischer, Deb [R-NE]
NE • R
Sponsored 10/27/2025
Gary Peters
MI • D
Sponsored 11/19/2025
Sen. Duckworth, Tammy [D-IL]
IL • D
Sponsored 12/4/2025
Sen. Ossoff, Jon [D-GA]
GA • D
Sponsored 12/9/2025
Sen. Smith, Tina [D-MN]
MN • D
Sponsored 12/16/2025
Sen. Collins, Susan M. [R-ME]
ME • R
Sponsored 2/12/2026
Sen. Gallego, Ruben [D-AZ]
AZ • D
Sponsored 2/24/2026
Sen. Warner, Mark R. [D-VA]
VA • D
Sponsored 2/25/2026
Peter Welch
VT • D
Sponsored 3/2/2026
Sen. Whitehouse, Sheldon [D-RI]
RI • D
Sponsored 3/5/2026
Sen. Murray, Patty [D-WA]
WA • D
Sponsored 3/5/2026
Sen. Hirono, Mazie K. [D-HI]
HI • D
Sponsored 3/10/2026
Sen. Kim, Andy [D-NJ]
NJ • D
Sponsored 3/10/2026
Sen. Cantwell, Maria [D-WA]
WA • D
Sponsored 3/17/2026
Shelley Capito
WV • R
Sponsored 3/25/2026
Sen. Justice, James C. [R-WV]
WV • R
Sponsored 4/28/2026
Roll Call Votes
No roll call votes available for this bill.
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