[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5509 Introduced in House (IH)]
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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
Committee on Education and Workforce
_______________________________________________________________________
A BILL
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Safe Step Act''.
SEC. 2. REQUIRED EXCEPTIONS PROCESS FOR MEDICATION STEP THERAPY
PROTOCOLS.
(a) Required Exceptions Process for Medication Step Therapy
Protocols.--The Employee Retirement Income Security Act of 1974 is
amended by inserting after section 713 of such Act (29 U.S.C. 1185b)
the following new section:
``SEC. 713A. REQUIRED EXCEPTIONS PROCESS FOR MEDICATION 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 transparent process
for a participant or beneficiary (or the prescribing health
care provider (referred to in this section as the `prescriber')
on behalf of the participant 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 medication step therapy
protocols satisfies the criteria and requirements of subsection
(b), cover the requested drug in accordance with the terms
established by the 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 subsection (a), are any of the following:
``(1) Any treatments otherwise required under the protocol,
or treatments in the same pharmacological class or having the
same mechanism of action, including treatments provided prior
to the effective date of the participant's or beneficiary's
coverage under the plan or coverage, have been ineffective in
the treatment of the disease or condition of the participant or
beneficiary, when prescribed consistent with clinical
indications, clinical guidelines, or other peer-reviewed
evidence, based on the prescribing health care professional's
judgement or relevant information provided by the participant
or beneficiary (including the medical records of the
participant or beneficiary).
``(2) Delay of effective treatment would lead to severe or
irreversible consequences, or worsen disease progression or a
comorbidity and the treatment otherwise required under the
protocol is reasonably expected by the prescriber to be
ineffective based upon the documented physical or mental
characteristics 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 achieving 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 relevant drug or drugs for the disease or
condition by any public or private health plan.
``(6) Other circumstances, as determined by the Secretary.
``(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 medical 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 additional information;
``(D) clearly set forth all required information
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 beneficiary
demonstrating that the participant or
beneficiary seeking an exception--
``(I) has tried other drugs
included in the drug therapy class
without 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 exception review;
``(E) not require the submission of any information
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 resolution from
the group health plan or health insurance 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.
``(2) Availability of process information.--The group
health plan or health insurance issuer shall make information
regarding the process required under subsection (a) readily
available in the relevant plan materials, including the summary
of benefits and, if available, on the website of the group
health plan or health insurance issuer. Such information shall
include--
``(A) the requirements for requesting an exception
to a medication step therapy protocol pursuant to this
section; and
``(B) any forms, supporting information, and
contact information, as appropriate.
``(d) Timing for Determination of Exception.--The process required
under subsection (a)(1) shall provide for the disposition of requests
received under such paragraph in accordance with the following:
``(1) Subject to paragraph (2), not later than 72 hours
after receiving an initial exception request, the plan or
issuer shall respond to the participant or beneficiary and, if
applicable, the requesting prescriber with either a
determination of exception eligibility or a request for
additional required information strictly necessary to make a
determination of whether the conditions specified in subsection
(b) are met. The plan or issuer shall respond to the
participant or beneficiary and, if applicable, the requesting
prescriber, with a determination of exception eligibility no
later than 72 hours after receipt of the additional required
information.
``(2) In the case of a request under circumstances in which
the applicable medication step therapy protocol may seriously
jeopardize the life or health of the participant or
beneficiary, may jeopardize the ability of the participant or
beneficiary to regain maximum function, or may subject the
participant or beneficiary to severe pain that cannot be
adequately managed without the treatment that is the subject of
the request, the plan or issuer shall conduct a review of the
request and respond to the participant or beneficiary and, if
applicable, the requesting prescriber, with either a
determination of exception eligibility or a request for
additional required information strictly necessary to make a
determination of whether the conditions specified in subsection
(b) are met, in accordance with the following:
``(A) If the plan or issuer can make a
determination of exception eligibility without
additional information, such determination shall be
made on an expedited basis, and no later than 24 hours
after receipt of such request.
``(B) If the plan or issuer requires additional
information before making a determination of exception
eligibility, the plan or issuer shall respond to the
participant or beneficiary and, if applicable, the
requesting prescriber, with a request for such
information within 24 hours of the request for a
determination, and shall respond with a determination
of exception eligibility as quickly as the condition or
disease requires, and no later than 24 hours after
receipt of the additional required information.
``(e) Duration of a Grant.--If an exception to a medication step
therapy protocol is granted under this section to a participant or
beneficiary, coverage for the requested drug shall remain in effect
with respect to such participant or beneficiary for not less than one
year.
``(f) Medication Step Therapy Protocol.--In this section, the term
`medication step therapy protocol' means a drug therapy utilization
management protocol or program under which a group health plan or
health insurance issuer offering group health insurance coverage of
prescription drugs requires a participant or beneficiary to try an
alternative preferred prescription drug or drugs before the plan or
health insurance issuer approves coverage for the non-preferred drug
therapy prescribed.
``(g) Clarification.--This section shall apply with respect to any
group health plan or health insurance coverage offered in connection
with such a plan that provides coverage of a prescription drug pursuant
to a policy that meets the definition of the term `medication step
therapy protocol' in subsection (f), regardless of whether such policy
is described by such group health plan or health insurance coverage as
a step therapy protocol.
``(h) Reporting.--
``(1) Reporting to the secretary.--Not later than 3 years
after the date of enactment of the Safe Step Act and not later
than October 1 of each year thereafter, each group health plan
and health insurance issuer offering group health insurance
coverage shall report to the Secretary, in such manner as the
Secretary shall require, the following:
``(A) The number of step therapy exception requests
received for each exception circumstance described in
paragraphs (1) through (6) of subsection (b), and the
numbers of such requests for each such circumstance
that were--
``(i) approved;
``(ii) denied, and the reasons for the
denials;
``(iii) initially denied and appealed; and
``(iv) initially denied and then
subsequently reversed by internal appeals or
external reviews.
``(B) The number of times a plan or issuer
requested additional information in response to a step
therapy exception request, by exception circumstance
described in paragraphs (1) through (6) of subsection
(b).
``(C) The number of exception requests submitted by
participants or beneficiaries, and the number of
exception requests submitted by prescribers, by medical
specialty.
``(D) The medical conditions for which participants
and beneficiaries were granted exceptions due to the
likelihood that switching from a prescription drug will
likely cause an adverse reaction by, or physical or
mental harm to, the participant or beneficiary, as
described in subsection (b)(3).
``(E) The entities responsible for providing
pharmacy benefit management services for the group
health plan or health insurance coverage.
``(2) Information.--A group health plan or health insurance
issuer offering group health insurance coverage shall not enter
into a contract with a third-party administrator or an entity
providing pharmacy benefit management services on behalf of the
plan or coverage that prevents the plan or issuer from
obtaining from the third-party administrator or the entity
providing pharmacy benefit management services any information
needed for the plan or issuer to comply with the reporting
requirements under paragraph (1).
``(3) Reports to congress.--Not later than 3 years after
the date of enactment of the Safe Step Act, and not later than
October 1 of each year thereafter, the Secretary shall submit
to Congress, and make publicly available, a report that
contains a summary and analysis of the information reported
under paragraph (1), including an analysis of, with respect to
requests for exceptions under this section, approvals, and
denials, including the reasons for denials; appeals and
external reviews; and trends, if any, in exception requests by
medical specialty or medical condition.''.
(b) Clerical Amendment.--The table of contents in section 1 of the
Employee Retirement Income Security Act of 1974 (29 U.S.C. 1001 et
seq.) is amended by inserting after the item relating to section 713
the following new item:
``Sec. 713A. Required exceptions process for medication step therapy
protocols.''.
(c) Effective Date.--
(1) In general.--The amendment made by subsection (a)
applies with respect to plan years beginning with the first
plan year that begins at least 6 months after the date of the
enactment of this Act.
(2) Regulations.--Not later than 6 months after the date of
the enactment of this Act, the Secretary of Labor shall issue
final regulations, through notice and comment rulemaking, to
implement the provisions of section 713A of the Employee
Retirement Income Security Act of 1974, as added by subsection
(a).
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