H.R. 5509: Safe Step Act

Introduced Sep 19, 202589 cosponsors

Sponsor

Rick Allen

Rick Allen

Republican · GA-12

Bill Progress

IntroducedSep 19
Committee 
Pass House 
Pass Senate 
Signed 
Law 

Latest Action · Sep 19, 2025

1/4

Referred to the House Committee on Education and Workforce.

A faster way past insurance 'fail first' drug rules

5 min readLast updated May 16, 2026

Why it matters

When your doctor prescribes a specific medicine, an employer health plan can make you try its cheaper picks first. That practice is called step therapy, or 'fail first.' H.R. 5509 would not ban it, but it would force workplace health plans to build a formal exceptions process: a decision within 72 hours, 24 hours when waiting could seriously harm you, and once an exception is granted it holds for at least a year. The bill has drawn 89 cosponsors from both parties and sits in the House Education and Workforce Committee.

The Safe Step Act takes aim at a routine insurance practice: before a plan covers the drug your doctor chose, it can require you to try one or more of its preferred alternatives first. Supporters of the bill argue that step therapy delays effective treatment, particularly for people with chronic or complex conditions who already know what works for them.

The bill does not outlaw step therapy. Instead, it requires workplace health plans to build a clear exceptions process and to grant the exception when one of six situations applies: the required drug already failed, it is expected to fail, it is unsafe or contraindicated, it would keep you from functioning at work or in daily life, or you are already stable on the drug your doctor prescribed and another health plan previously covered it.

H.R. 5509 Bill Summary

What H.R. 5509 actually does.

1

You get a formal way to challenge a 'fail first' rule

Workplace health plans that use step therapy would have to run a clear, transparent process letting you or your doctor request an exception, and cover the prescribed drug when the request qualifies.

2

Six situations force the plan to grant an exception

An exception must be approved if the required drug already failed, is expected to be ineffective, is unsafe or contraindicated, would keep you from functioning at work or daily life, or you are already stable on the prescribed drug and another plan previously covered it.

3

A 72-hour clock, or 24 hours when it is urgent

Plans must respond within 72 hours of a standard request. When delay could seriously jeopardize health, the ability to regain function, or cause unmanageable pain, the decision comes within 24 hours.

4

An approved exception lasts at least a year

Once a plan grants an exception, coverage for that drug stays in effect for the patient for no less than one year.

5

Standard forms, less paperwork, an advocate can file for you

Plans must use a standard paper and electronic form, ask only for information strictly necessary to decide, and allow a representative, including a third-party advocate, to act on your behalf.

6

Annual reporting to the Labor Department

Plans would report exception requests, approvals, denials, and appeals, and the Secretary would publish an annual analysis for Congress starting three years after enactment.

Who benefits from H.R. 5509?

People with chronic or complex conditions

Patients managing illnesses like rheumatoid arthritis, multiple sclerosis, Crohn's disease, psoriasis, cancer, or serious mental illness, where cycling through drugs that do not work can mean months of lost ground.

Anyone changing jobs or health plans

If you are stable on a medication and your previous plan covered it, your new employer plan would have to grant an exception instead of restarting you on its preferred drug.

Doctors and prescribing clinicians

They get one standard, time-limited process for arguing that step therapy is medically wrong for a patient, instead of plan-by-plan paperwork with no deadline.

Caregivers and patient advocates

The bill lets a representative, including a designated third-party advocate, file and pursue an exception for someone too sick or overwhelmed to navigate it alone.

Who is affected by H.R. 5509?

Employer-sponsored health plans

Private-sector plans governed by federal benefits law would have to redesign their step-therapy procedures, forms, notices, and review timelines to comply.

Insurers and pharmacy benefit managers

Companies administering these plans would face the 72-hour and 24-hour deadlines, documentation limits, and the annual reporting requirement to the Labor Department.

Employers offering health benefits

Companies could see changes in plan administration and potentially higher prescription drug spending if more patients gain access to non-preferred medications sooner.

People on Medicare, Medicaid, or marketplace plans

This bill amends employer-benefits law, so it would not change step-therapy rules for those coverage types, which are governed separately.

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Tracking floor activity — no debate on H.R. 5509 yet. Updates when a legislator speaks on the record.

HR5509 Legislative Journey

1 actions

House: Committee Action

Sep 19, 2025

Referred to the House Committee on Education and Workforce.

About the Sponsor

Rick Allen

Rick Allen

Republican, Georgia's 12th congressional district · 11 years in Congress

Committees: Education and Workforce, Energy and Commerce

View full profile →

Cosponsors (89)

No new cosponsors in 90 days — momentum stalled

This bill has 89 cosponsors: 69 Democrats, 20 Republicans, reflecting bipartisan support. Cosponsors represent 33 states: Arkansas, California, Connecticut, and 30 more.

69Democrats20Republicans·33 statesBipartisan

Committee Sponsors

Education and Workforce Committee

16D20R
|9 signed27 not yet

9 of 36 committee members cosponsored

17 Republicans across this committee haven't cosponsored yet. Mobilize their constituents

What laws does H.R. 5509 change?

1 changes

Full Text

Sections Amended

Section 1 of Employee Retirement Income Security Act of 1974 (29 U.S.C. 1001 et seq.)

inserting after the item relating to section 713 the following new item: ``Sec

H.R. 5509 Quick Facts

Cosponsors
89
Lucy McBath
Mariannette Miller-Meeks
Raul Ruiz
Robert Onder
Christopher Deluzio
+84 more
Committee
Education and Workforce
Chamber
House
Policy
Health
Introduced
Sep 19, 2025

Referred to the House Committee on Education and Workforce.

Sep 19, 2025

Constituent Resources

Get notified when this bill moves

Official Sources

H.R. 5509 on Congress.gov

The official bill page with full text, current status, the 89 cosponsors, and the House Education and Workforce Committee referral.

ERISA §713 (29 U.S.C. 1185b)

The Safe Step Act inserts its new step-therapy exceptions section (713A) directly after this section of the Employee Retirement Income Security Act.

Employee Retirement Income Security Act (29 U.S.C. Chapter 18)

The federal law the bill amends; ERISA governs private-sector, employer-sponsored group health plans and is enforced by the Department of Labor, which is why this bill does not reach Medicare, Medicaid, or marketplace coverage.

29 CFR Part 2590 — Rules and Regulations for Group Health Plans

The Labor Department's ERISA Part 7 group-health-plan regulations, where the Secretary's implementing rules for the bill's required exceptions process would be codified.

42 CFR 441.505 — Activities of Daily Living Definition

The bill cites this regulation's definition of 'activities of daily living' to define one of the six circumstances that force a plan to grant a step-therapy exception.

Who is lobbying on H.R. 5509?

2 organizations lobbying on this bill

Total filings: 4
THE HS COALITION
2
CROHN'S & COLITIS FOUNDATION
2

Showing 1-2 of 2 organizations

H.R. 5509 Common Questions

What is step therapy, or 'fail first'?

It is when your health plan makes you try one or more of its preferred, usually cheaper, drugs before it will cover the medicine your doctor actually prescribed. H.R. 5509 does not ban the practice, but it forces employer plans to offer a fast way to get an exception.

How fast would my insurer have to decide an exception request?

Within 72 hours of a standard request. If waiting could seriously jeopardize your health, your ability to regain function, or leave you in severe pain, the plan must respond within 24 hours.

What situations force my plan to grant a step therapy exception?

Six: the required drug already failed for you, it is expected to be ineffective, it is unsafe or contraindicated, it would keep you from functioning at work or daily life, or you are already stable on the prescribed drug and another health plan previously covered it.

If I switch jobs, can I keep the medication I'm stable on?

Under H.R. 5509, yes. If you are stable on a drug your doctor prescribed and any public or private plan previously covered it, your new employer plan must grant an exception instead of restarting you on its preferred drug.

How long does a step therapy exception last once it is granted?

At least one year. Under H.R. 5509, once a plan approves an exception, coverage for that drug must stay in effect for the patient for no less than 12 months.

Does the Safe Step Act cover Medicare, Medicaid, or marketplace plans?

No. H.R. 5509 amends the federal law governing private-sector, employer-sponsored group health plans, so it applies to workplace coverage. Medicare, Medicaid, and individual marketplace plans are regulated separately and are not changed by this bill.

Can someone file the exception request for me?

Yes. H.R. 5509 lets you authorize a representative, including a designated third-party advocate, to request and pursue a step therapy exception on your behalf. Your prescribing doctor can also file the request.

When would the Safe Step Act take effect if it passes?

It applies starting with the first plan year that begins at least six months after enactment, and the Labor Department must issue final rules within six months. As of now the bill is in the House Education and Workforce Committee with 89 bipartisan cosponsors.

Based on H.R. 5509 bill text

H.R. 5509 Bill Text

PDF

To amend the Employee Retirement Income Security Act of 1974 to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes.

Source: U.S. Government Publishing Office

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