Title: Safe Step Act
Policy area: Health

Summary:
Safe Step Act
This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer.
A request for such an exception to the protocol must be granted if (1) an otherwise required treatment has been ineffective, (2) such treatment is expected to be ineffective and delaying effective treatment would lead to irreversible consequences, (3) such treatment will cause or is likely to cause an adverse reaction to the individual, (4) such treatment is expected to prevent the individual from performing daily activities or occupational responsibilities, (5) the individual is stable based on the prescription drugs already selected, or (6) there are other circumstances as determined by the Employee Benefits Security Administration.
The bill requires a group health plan to implement and make readily available a clear process for an individual to request an exception to the protocol, including required information and criteria for granting an exception. The bill further specifies timelines under which plans must respond to such requests.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 464 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                 S. 464

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

                           February 25, 2021

 Ms. Murkowski (for herself, Ms. Hassan, Mr. Cassidy, Ms. Rosen, Mrs. 
 Hyde-Smith, Mrs. Gillibrand, Ms. Sinema, Mrs. Capito, Ms. Hirono, Mr. 
  Tillis, Mrs. Shaheen, Mr. Cramer, Mr. Merkley, and Mr. Blumenthal) 
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) In General.--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 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 coverage shall--
            ``(1) implement a clear and transparent process for a 
        participant or beneficiary (or the prescribing health care 
        provider 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 prescribing 
        health care provider'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 health plan or 
        coverage for patient cost-sharing rates or amounts at the time 
        of the participant's or beneficiary's enrollment in the health 
        plan or health insurance coverage.
    ``(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, 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.
            ``(2) Delay of effective treatment would lead to severe or 
        irreversible consequences, and the treatment otherwise required 
        under the protocol is reasonably expected 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 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 prescribing health care provider and has 
        previously received approval for coverage of the relevant drug 
        or drugs for the disease or condition by any group health plan 
        or health insurance issuer.
            ``(6) Other circumstances, as determined by the Secretary.
    ``(c) Requirement of a Clear Process.--
            ``(1) In general.--The process required by subsection (a)--
                    ``(A) shall provide the prescribing health care 
                provider or beneficiary or designated third-party 
                advocate an opportunity to present such provider's 
                clinical rationale and relevant medical information for 
                the group health plan or health insurance issuer to 
                evaluate such request for exception;
                    ``(B) shall 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;
                    ``(C) may not require the submission of any 
                information or supporting documentation beyond what is 
                strictly necessary to determine whether any of the 
                circumstances listed in subsection (b) exists; and
                    ``(D) shall 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).
            ``(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 on the internet 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 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 requesting 
        provider 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, the plan or issuer shall conduct a review of the 
        request and respond to 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 
                requesting provider 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) 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.
    ``(f) 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 (e), regardless of whether such policy 
is described by such group health plan or health insurance coverage as 
a step therapy protocol.''.
    (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 items:

``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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