119-s2903

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2903 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 2903

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 SENATE OF THE UNITED STATES

 September 18 (legislative day, September 16), 2025

 Ms. Murkowski (for herself, Ms. Hassan, Mr. Marshall, Ms. Rosen, Mr. 
Padilla, Mr. Hickenlooper, Mr. Merkley, Mr. Sullivan, Mr. Warnock, Mrs. 
 Hyde-Smith, Ms. Cortez Masto, Mr. Moran, Mr. Cramer, Mr. Kaine, Mr. 
 Budd, Mrs. Shaheen, Mr. Booker, Mr. Wyden, and Mr. Coons) introduced 
the following bill; which was read twice and referred to the Committee 
 on Health, Education, Labor, and Pensions

_______________________________________________________________________

 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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