Safe Step Act

IntroducedSeptember 18, 2025

Introduced4 months ago

Intro

Senate

House

Pres

Committee on Health, Education, Labor, and Pensions. Hearings held.

HealthCongressional oversightGovernment information and archivesDrug therapyPrescription drugsHealth care costs and insurance

Why This Matters

The Safe Step Act requires group health plans and insurers to provide a clear and timely process for patients or their doctors to request exceptions to medication step therapy rules. It also sets deadlines for decisions and annual reporting requirements.

Who this affects

group health plans · health insurance issuers · participants · beneficiaries

What changes is this bill making?

1Step therapy requires patients to try a preferred drug before a non-preferred drug is covered.
2The bill mandates a transparent exception process so patients or prescribers can request coverage of a different drug.
3Exceptions must be approved if prior drugs were ineffective, caused harm, are contraindicated, or would delay urgently needed treatment.
4Plans must use standard forms, allow paper and electronic submissions, and ask only for information strictly needed to decide.
5Plans must decide routine exception requests within 72 hours and urgent requests within 24 hours.
6Approved exceptions must remain in effect for at least one year.
7Plans must report annually to the Secretary of Labor on exception requests, approvals, denials, appeals, and trends; the Secretary must report to Congress.

Read full document

Safe Step Act

IntroducedSeptember 18, 2025

Introduced4 months ago

Intro

Senate

House

Pres

Committee on Health, Education, Labor, and Pensions. Hearings held.

HealthCongressional oversightGovernment information and archivesDrug therapyPrescription drugsHealth care costs and insurance

Why This Matters

Who this affects

group health plans · health insurance issuers · participants · beneficiaries

What changes is this bill making?

1Step therapy requires patients to try a preferred drug before a non-preferred drug is covered.
2The bill mandates a transparent exception process so patients or prescribers can request coverage of a different drug.
3Exceptions must be approved if prior drugs were ineffective, caused harm, are contraindicated, or would delay urgently needed treatment.
4Plans must use standard forms, allow paper and electronic submissions, and ask only for information strictly needed to decide.
5Plans must decide routine exception requests within 72 hours and urgent requests within 24 hours.
6Approved exceptions must remain in effect for at least one year.
7Plans must report annually to the Secretary of Labor on exception requests, approvals, denials, appeals, and trends; the Secretary must report to Congress.

Read full document