I 
119TH CONGRESS 
1ST SESSION H. R. 5509 
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. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 19, 2025 
Mr. ALLEN (for himself, Mrs. MCBATH, Mrs. MILLER-MEEKS, Mr. RUIZ, and 
Mr. ONDER) introduced the following bill; which was referred to the Com-
mittee on Education and Workforce 
A BILL 
To amend the Employee Retirement Income Security Act 
of 1974 to require a group health plan or health insur-
ance coverage offered in connection with such a plan 
to provide an exceptions process for any medication step 
therapy protocol, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safe Step Act’’. 
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SEC. 2. REQUIRED EXCEPTIONS PROCESS FOR MEDICA-
TION STEP THERAPY PROTOCOLS. 
(a) REQUIRED EXCEPTIONS PROCESS FOR MEDICA-
TION STEP THERAPY PROTOCOLS.—The Employee Re-
tirement Income Security Act of 1974 is amended by in-
serting after section 713 of such Act (29 U.S.C. 1185b) 
the following new section: 
‘‘SEC. 713A. REQUIRED EXCEPTIONS PROCESS FOR MEDI-
CATION STEP THERAPY PROTOCOLS. 
‘‘(a) IN GENERAL.—In the case of a group health 
plan or health insurance issuer offering coverage offered 
in connection with such a plan that provides coverage of 
a prescription drug pursuant to a medication step therapy 
protocol, the plan or issuer shall— 
‘‘(1) implement a clear, prompt, and trans-
parent process for a participant or beneficiary (or 
the prescribing health care provider (referred to in 
this section as the ‘prescriber’) on behalf of the par-
ticipant or beneficiary) to request an exception to 
such medication step therapy protocol, pursuant to 
subsection (b); and 
‘‘(2) where the participant or beneficiary or 
prescriber’s request for an exception to the medica-
tion step therapy protocols satisfies the criteria and 
requirements of subsection (b), cover the requested 
drug in accordance with the terms established by the 
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plan or coverage for patient cost-sharing rates or 
amounts at the beginning of the plan year. 
‘‘(b) CIRCUMSTANCES FOR EXCEPTION APPROVAL.— 
The circumstances requiring an exception to a medication 
step therapy protocol, pursuant to a request under sub-
section (a), are any of the following: 
‘‘(1) Any treatments otherwise required under 
the protocol, or treatments in the same pharma-
cological class or having the same mechanism of ac-
tion, including treatments provided prior to the ef-
fective date of the participant’s or beneficiary’s cov-
erage under the plan or coverage, have been ineffec-
tive in the treatment of the disease or condition of 
the participant or beneficiary, when prescribed con-
sistent with clinical indications, clinical guidelines, or 
other peer-reviewed evidence, based on the pre-
scribing health care professional’s judgement or rel-
evant information provided by the participant or 
beneficiary (including the medical records of the par-
ticipant or beneficiary). 
‘‘(2) Delay of effective treatment would lead to 
severe or irreversible consequences, or worsen dis-
ease progression or a comorbidity and the treatment 
otherwise required under the protocol is reasonably 
expected by the prescriber to be ineffective based 
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upon the documented physical or mental characteris-
tics of the participant or beneficiary and the known 
characteristics of such treatment. 
‘‘(3) Any treatments otherwise required under 
the protocol are contraindicated for the participant 
or beneficiary or have caused, or are likely to cause, 
based on clinical, peer-reviewed evidence, an adverse 
reaction or other physical or mental harm to the 
participant or beneficiary. 
‘‘(4) Any treatment otherwise required under 
the protocol has prevented, will prevent, or is likely 
to prevent a participant or beneficiary from achiev-
ing or maintaining reasonable and safe functional 
ability in performing occupational responsibilities or 
activities of daily living (as defined in section 
441.505 of title 42, Code of Federal Regulations (or 
successor regulations)). 
‘‘(5) The participant or beneficiary is stable for 
his or her disease or condition on the prescription 
drug or drugs selected by the prescriber and has 
previously received approval for coverage of the rel-
evant drug or drugs for the disease or condition by 
any public or private health plan. 
‘‘(6) Other circumstances, as determined by the 
Secretary. 
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‘‘(c) REQUIREMENT OF A CLEAR PROCESS.— 
‘‘(1) IN
GENERAL.—The process required by 
subsection (a) shall— 
‘‘(A) provide the prescriber or participant 
or beneficiary an opportunity to present such 
prescriber’s clinical rationale and relevant med-
ical information for the group health plan or 
health insurance issuer to evaluate such request 
for exception; 
‘‘(B) develop and use a standard form and 
instructions for the request of an exception 
under subsection (b), available in paper and 
electronic forms, and allow for submission of 
such form by paper and electronic means; 
‘‘(C) provide both paper and electronic 
means for the submission of requests for addi-
tional information; 
‘‘(D) clearly set forth all required informa-
tion and the specific criteria that will be used 
to determine whether an exception is warranted, 
which may require disclosure of— 
‘‘(i) the medical history or other 
health records of the participant or bene-
ficiary demonstrating that the participant 
or beneficiary seeking an exception— 
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‘‘(I) has tried other drugs in-
cluded in the drug therapy class with-
out success; or 
‘‘(II) has taken the requested 
drug for a clinically appropriate 
amount of time to establish stability, 
in relation to the condition being 
treated and prescription guidelines 
given by the prescribing physician; or 
‘‘(ii) other clinical information that 
may be relevant to conducting the excep-
tion review; 
‘‘(E) not require the submission of any in-
formation or supporting documentation beyond 
what is strictly necessary (as determined by the 
Secretary) to determine whether a circumstance 
listed in subsection (b) exists; 
‘‘(F) clearly outline conditions under which 
an exception request warrants expedited resolu-
tion from the group health plan or health insur-
ance issuer, pursuant to subsection (d)(2); and 
‘‘(G) allow a representative of a participant 
or beneficiary, which may include a designated 
third-party advocate, to act on behalf of the 
participant or beneficiary. 
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