I 116th CONGRESS 1st Session H. R. 2279 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.

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 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).