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Safe Step Act

H.R. 5509 Rep. Rick Allen (R-GA-12) In committee
Bill text PDF
  1. Introduced Sep 19
  2. Committee Sep 19
  3. Passed House Next
  4. Passed Senate Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, Sep 19, 2025Next: House vote
404d ago Sep 19, 2025: Referred to the House Committee on Education and Workforce.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
8companies, 24 filings
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16trades in the last 90 days
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Summary

This bill amends the Employee Retirement Income Security Act of 1974 to require group health plans and health insurance issuers that use medication step therapy protocols to have a clear, prompt, and transparent exceptions process for patients or their prescribers to request a waiver of the step therapy requirements.

Sec. 2, Required exceptions process for medication step therapy protocols: The bill adds a new section to ERISA requiring plans to implement an exceptions process. Exceptions must be granted if: (1) required treatments have been ineffective; (2) delay would cause severe or irreversible harm; (3) required treatments are contraindicated or likely to cause harm; (4) required treatments prevent reasonable daily functioning; (5) the patient is stable on a drug previously approved by any health plan; or (6) other circumstances determined by the Secretary. The process must include a standard form, allow paper and electronic submission, not require unnecessary information, and allow a representative to act for the patient. Plans must respond to standard requests within 72 hours, and to expedited requests (where life or health is at risk) within 24 hours. If an exception is granted, coverage for the requested drug must last at least one year. Plans must report to the Secretary annually on the number of requests, approvals, denials, appeals, and other data, and the Secretary must submit a summary report to Congress. The bill applies to plan years beginning at least 6 months after enactment, and the Secretary must issue final regulations within 6 months.

Summary of the bill text as introduced in House (Sep 19, 2025), generated by SecBot from the official bill text; the Library of Congress summary is not yet published.

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 27, 2026.