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) the treatment is expected to be ineffective, (2) the treatment will cause or is likely to cause an adverse reaction to the individual, (3) the treatment is expected to decrease the individual's ability either to perform daily activities or occupational responsibilities or adhere to the treatment plan, (4) the individual is stable based on the prescription drugs already selected, or (5) there are other medical reasons that warrant withholding the treatment.
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. Requests must be granted no later than three days after receipt of the request. In certain cases where the life, health, and ability of the individual are jeopardized by the protocol, the request shall be granted no later than 24 hours after receipt of the request.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2279 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 2279

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

                             April 10, 2019

Mr. Ruiz (for himself and Mr. Wenstrup) introduced the following bill; 
       which was referred to the Committee on Education and Labor

_______________________________________________________________________

                                 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 715 of such Act (29 U.S.C. 
1185d) the following new section:

``SEC. 716. 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 process for a participant or 
        beneficiary (or the prescribing health care provider) to 
        request an exception to such medication step therapy protocol; 
        and
            ``(2) if such a request demonstrates (through supporting 
        documentation, if necessary) that any of the circumstances 
        listed in subsection (b) exists, authorize coverage for the 
        prescription drug without regard to such medication step 
        therapy protocol.
    ``(b) Expedited Approval.--The circumstances warranting an 
exception to a medication step therapy protocol, pursuant to a request 
under subsection (a), are any of the following:
            ``(1) The treatment otherwise required under the protocol, 
        or a drug or drugs in the same pharmacological class or having 
        the same mechanism of action, are contraindicated or have been 
        ineffective in the treatment of the disease or condition of the 
        participant or beneficiary.
            ``(2) The treatment otherwise required under the protocol 
        is reasonably expected to be ineffective based upon--
                    ``(A) the known physical or mental characteristics 
                of the participant or beneficiary, including medical 
                history; and
                    ``(B) the known characteristics of such treatment.
            ``(3) The treatment otherwise required under the protocol 
        will cause or is likely to cause an adverse reaction or other 
        physical harm to the participant or beneficiary.
            ``(4) The treatment otherwise required under the protocol 
        is not in the best interest of the participant or beneficiary, 
        based on medical necessity, because the participant or 
        beneficiary's use of such treatment is expected to decrease the 
        participant or beneficiary's ability--
                    ``(A) to achieve or maintain reasonable and safe 
                functional ability in performing daily activities or 
                occupational responsibilities; or
                    ``(B) to adhere to the treatment plan as defined by 
                the prescribing health care provider.
            ``(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.
    ``(c) Clear Process.--The process required by subsection (a)(1)--
            ``(1) shall make information regarding such process readily 
        available on the website of the group health plan, including--
                    ``(A) the requirements for requesting an exception 
                to a medication step therapy protocol pursuant to this 
                section; and
                    ``(B) any necessary forms, supporting information, 
                and contact information; and
            ``(2) 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.
    ``(d) Timing for Granting Exception.--The process required by 
subsection (a)(1) shall provide for the disposition of requests 
received under such paragraph in accordance with the following:
            ``(1) Such a request shall be granted as quickly as the 
        disease or condition of the participant or beneficiary 
        requires, but no later than 3 days after the day of receipt of 
        the request.
            ``(2) For circumstances in which the applicable medication 
        step therapy protocol may seriously jeopardize the life, 
        health, or ability to regain maximum function of the 
        participant or beneficiary, such a request shall be granted--
                    ``(A) on an expedited basis; and
                    ``(B) no later than 24 hours after receipt of such 
                request.
    ``(e) Medication Step Therapy Protocol.--In this section, the term 
`medication step therapy protocol' means a protocol or program that 
establishes a specific sequence in which prescription drugs that--
            ``(1) are for a specified disease or condition; and
            ``(2) are medically necessary for a particular patient,
are covered under a pharmacy or medical benefit by a group health plan 
or a health insurance issuer offering group or individual health 
insurance coverage.
    ``(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) Technical Correction; Clerical Change.--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 714 the following new items:

``Sec. 715. Additional market reforms.
``Sec. 716. Required exceptions process for medication step therapy 
                            protocols.''.
    (c) Effective Date.--
            (1) In general.--The amendment made by subsection (a) 
        applies to plan years beginning no sooner than 6 months after 
        the date of the enactment of this Act.
            (2) Regulations.--Not later than the date that is 9 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 716 of the 
        Employee Retirement Income Security Act of 1974, as added by 
        subsection (a).
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