II 116th CONGRESS 1st Session S. 2546 IN THE SENATE OF THE UNITED STATES September 25, 2019 Ms. Murkowski (for herself, Mr. Jones , Mr. Cassidy , Ms. Hassan , Mrs. Hyde-Smith , Ms. Rosen , Mr. Cramer , and Mr. King ) 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.

1. Short title This Act may be cited as the Safe Step Act . 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: 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 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 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 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 716 of the Employee Retirement Income Security Act of 1974, as added by subsection (a).