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HR 5509
Recent Bills/HR 5509

Safe Step Act

IntroducedSeptember 19, 2025
Introduced10 months ago
Intro
House
Senate
Pres
Referred to the House Committee on Education and Workforce.
HealthCongressional oversightGovernment information and archivesDrug therapyPrescription drugsHealth care costs and insurance
Why This Matters

This bill amends the Employee Retirement Income Security Act of 1974 (ERISA) to require group health plans and insurers to offer a clear exceptions process for step therapy drug protocols. It sets criteria for approving exceptions, deadlines for decisions, and reporting duties.

Who this affects
group health plans · health insurance issuers · plan participants · prescribing health care providers
What changes is this bill making?
  1. 1Step therapy protocols require patients to try a preferred drug before covering a nonpreferred one.
  2. 2Plans and insurers must provide a clear, prompt, transparent process for participants or their prescribers to request exceptions to these protocols.
  3. 3Exceptions must be approved if required drugs have been ineffective or harmful, if delays pose serious health risks or functional harm, or if a patient is already stable on the requested drug.
  4. 4Plans must use standard forms, allow paper and electronic submissions, clearly list needed information, and let third-party advocates submit requests.
  5. 5Plans must respond to standard exception requests within 72 hours and to urgent requests that risk serious harm within 24 hours.
  6. 6Approved exceptions must remain in effect for at least one year.
  7. 7Plans and insurers must report annually to the Secretary of Labor on exception requests, decisions, and related data; the Secretary must report to Congress.
  8. 8The rules apply to plan years starting six months after enactment and the Secretary must issue final regulations within six months.
Read full document
Bill Progress1 of 4
Bills must pass the House, Senate, and be signed by the President to become law.
Intro
House
Senate
Pres
IntroducedCurrentSep 19, 2025

Referred to the House Committee on Education and Workforce.

Sponsors
See all 149 sponsors
House
Senate
President

The President

Donald Trump
President
Awaiting Vote
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