HR5509-119

In Committee

Safe Step Act

119th Congress Introduced Sep 19, 2025

Summary

What This Bill Does

The bill amends ERISA by inserting new Section 713A requiring group health plans and insurers to establish step therapy exception processes with defined criteria, timelines, annual reporting requirements, and implementing and requires new ERISA Section 713A establishing step therapy exception process: six defined exception circumstances, 72-hour standard and 24-hour expedited determination timelines, minimum 1-year coverage duration. It relies on compliance mandates, reporting requirements, and exemptions. The main policy areas are Healthcare, Health Insurance Regulation, Finance, and Social Welfare.

Who Benefits and How

Prescribing healthcare providers could face fewer barriers, Brand-name and specialty pharmaceutical manufacturers could gain revenue opportunities, and Patients on step therapy protocols could face fewer barriers.

Who Bears the Burden and How

Group health plans and health insurance issuers would take on compliance duties, Pharmacy benefit managers (PBMs) would take on compliance duties, and Generic and preferred-drug pharmaceutical manufacturers could lose revenue opportunities.

Key Provisions

  • Amends ERISA by inserting new Section 713A requiring group health plans and insurers to establish step therapy exception processes with defined criteria, timelines, annual reporting requirements, and implementing...
  • Requires new ERISA Section 713A establishing step therapy exception process: six defined exception circumstances, 72-hour standard and 24-hour expedited determination timelines, minimum 1-year coverage duration...

Evidence Chain:

This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.

At a Glance

What This Bill Does

The bill amends ERISA by inserting new Section 713A requiring group health plans and insurers to establish step therapy exception processes with defined criteria, timelines, annual reporting requirements, and implementing and requires new ERISA Section 713A establishing step therapy exception process: six defined exception circumstances, 72-hour standard and 24-hour expedited determination timelines, minimum 1-year coverage duration.

Key Policy Areas

Healthcare, Health Insurance Regulation, Finance, Social Welfare

Primary Purpose

The bill amends ERISA by inserting new Section 713A requiring group health plans and insurers to establish step therapy exception processes with defined criteria, timelines, annual reporting requirements, and implementing and requires new ERISA Section 713A establishing step therapy exception process: six defined exception circumstances, 72-hour standard and 24-hour expedited determination timelines, minimum 1-year coverage duration.

Policy Domains

Healthcare Health Insurance Regulation Finance Social Welfare

Whole bill

Identified Gains
  • Prescribing healthcare providers
  • Brand-name and specialty pharmaceutical manufacturers
  • Patients on step therapy protocols
  • Patients enrolled in employer-sponsored group health plans
  • Pharmacy benefit managers (PBMs) - transparency restrictions
Model: codex-gpt-5:bulk-repair | Version: bill_summary_v2 | Source: ih
Prescribing healthcare providers: ,
Patients on step therapy protocols:
Brand-name and specialty pharmaceutical manufacturers: ,
Patients enrolled in employer-sponsored group health plans:
Pharmacy benefit managers (PBMs) - transparency restrictions:
Identified Costs
  • Group health plans and health insurance issuers
  • Pharmacy benefit managers (PBMs)
  • Generic and preferred-drug pharmaceutical manufacturers
  • Department of Labor
Model: codex-gpt-5:bulk-repair | Version: bill_summary_v2 | Source: ih
Department of Labor:
Pharmacy benefit managers (PBMs): ,
Group health plans and health insurance issuers: ,
Generic and preferred-drug pharmaceutical manufacturers: ,

Legislative Progress

In Committee
Introduced Committee Passed
Sep 19, 2025

Mr. Allen (for himself, Mrs. McBath, Mrs. Miller-Meeks, Mr. Ruiz, …

Sep 19, 2025

Referred to the House Committee on Education and Workforce.

Sep 19, 2025

Introduced in House

Stakeholder Effects

cui bono?

How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.

Pharmaceuticals
4 mentions across 2 clauses
+2 positive -2 negative

Brand-name and specialty pharmaceutical manufacturers, Generic and preferred-drug pharmaceutical manufacturers

Positive-direction: Brand-name and specialty pharmaceutical manufacturers

Negative-direction: Generic and preferred-drug pharmaceutical manufacturers

Pharmacy Benefit Management
3 mentions across 2 clauses
-3 negative

Pharmacy benefit managers (PBMs), Pharmacy benefit managers (PBMs) - transparency restrictions

Financial Services
2 mentions across 2 clauses
-2 negative

Group health plans and health insurance issuers

General Public
2 mentions across 2 clauses
+2 positive

Patients enrolled in employer-sponsored group health plans, Patients on step therapy protocols

Health Professionals
2 mentions across 2 clauses
+2 positive

Prescribing healthcare providers

Government
1 mention across 1 clause
-1 negative

Department of Labor

2/3
sections analyzed
Full impact breakdown

Bill Structure & Actor Mappings

Who is "The Secretary" in each section?

Domains
Healthcare Health Insurance Regulation Finance Social Welfare

We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.

Learn more about our methodology