Safe Step Act

II 118TH CONGRESS 1ST SESSION S. 652 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 MARCH 2, 2023 Ms. MURKOWSKI (for herself, Ms. HASSAN, Mr. MARSHALL, Ms. ROSEN, Mr. TILLIS, Mr. MERKLEY, Mrs. CAPITO, Ms. CORTEZ MASTO, Mrs. HYDE- SMITH, Mr. BLUMENTHAL, Ms. LUMMIS, Ms. SMITH, Mr. CRAMER, Ms. SINEMA, Ms. COLLINS, Mr. CASEY, Mr. KAINE, Mr. WICKER, and Mrs. GILLIBRAND) introduced the following bill; which was read twice and re- ferred 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 insur- ance 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Safe Step Act’’. 4 VerDate Sep 11 2014 07:48 Mar 15, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 kjohnson on DSK79L0C42PROD with BILLS 2 •S 652 IS SEC. 2. REQUIRED EXCEPTIONS PROCESS FOR MEDICA- 1 TION STEP THERAPY PROTOCOLS. 2 (a) IN GENERAL.—The Employee Retirement Income 3 Security Act of 1974 is amended by inserting after section 4 713 of such Act (29 U.S.C. 1185b) the following new sec- 5 tion: 6 ‘‘SEC. 713A. REQUIRED EXCEPTIONS PROCESS FOR MEDI- 7 CATION STEP THERAPY PROTOCOLS. 8 ‘‘(a) IN GENERAL.—In the case of a group health 9 plan or health insurance coverage offered in connection 10 with such a plan that provides coverage of a prescription 11 drug pursuant to a medication step therapy protocol, the 12 plan or coverage shall— 13 ‘‘(1) implement a clear and transparent process 14 for a participant or beneficiary (or the prescribing 15 health care provider on behalf of the participant or 16 beneficiary) to request an exception to such medica- 17 tion step therapy protocol, pursuant to subsection 18 (b); and 19 ‘‘(2) where the participant or beneficiary or 20 prescribing health care provider’s request for an ex- 21 ception to the medication step therapy protocols sat- 22 isfies the criteria and requirements of subsection (b), 23 cover the requested drug in accordance with the 24 terms established by the health plan or coverage for 25 patient cost-sharing rates or amounts at the time of 26 VerDate Sep 11 2014 07:48 Mar 15, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 kjohnson on DSK79L0C42PROD with BILLS 3 •S 652 IS the participant’s or beneficiary’s enrollment in the 1 health plan or health insurance coverage. 2 ‘‘(b) CIRCUMSTANCES FOR EXCEPTION APPROVAL.— 3 The circumstances requiring an exception to a medication 4 step therapy protocol, pursuant to a request under sub- 5 section (a), are any of the following: 6 ‘‘(1) Any treatments otherwise required under 7 the protocol, or treatments in the same pharma- 8 cological class or having the same mechanism of ac- 9 tion, have been ineffective in the treatment of the 10 disease or condition of the participant or beneficiary, 11 when prescribed consistent with clinical indications, 12 clinical guidelines, or other peer-reviewed evidence. 13 ‘‘(2) Delay of effective treatment would lead to 14 severe or irreversible consequences, and the treat- 15 ment otherwise required under the protocol is rea- 16 sonably expected to be ineffective based upon the 17 documented physical or mental characteristics of the 18 participant or beneficiary and the known character- 19 istics of such treatment. 20 ‘‘(3) Any treatments otherwise required under 21 the protocol are contraindicated for the participant 22 or beneficiary or have caused, or are likely to cause, 23 based on clinical, peer-reviewed evidence, an adverse 24 VerDate Sep 11 2014 07:48 Mar 15, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 kjohnson on DSK79L0C42PROD with BILLS 4 •S 652 IS reaction or other physical harm to the participant or 1 beneficiary. 2 ‘‘(4) Any treatment otherwise required under 3 the protocol has prevented, will prevent, or is likely 4 to prevent a participant or beneficiary from achiev- 5 ing or maintaining reasonable and safe functional 6 ability in performing occupational responsibilities or 7 activities of daily living (as defined in section 8 441.505 of title 42, Code of Federal Regulations (or 9 successor regulations)). 10 ‘‘(5) The participant or beneficiary is stable for 11 his or her disease or condition on the prescription 12 drug or drugs selected by the prescribing health care 13 provider and has previously received approval for 14 coverage of the relevant drug or drugs for the dis- 15 ease or condition by any group health plan or health 16 insurance issuer. 17 ‘‘(6) Other circumstances, as determined by the 18 Secretary. 19 ‘‘(c) REQUIREMENT OF A CLEAR PROCESS.— 20 ‘‘(1) IN GENERAL.—The process required by 21 subsection (a)— 22 ‘‘(A) shall provide the prescribing health 23 care provider or beneficiary or designated third- 24 party advocate an opportunity to present such 25 VerDate Sep 11 2014 07:48 Mar 15, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 kjohnson on DSK79L0C42PROD with BILLS 5 •S 652 IS provider’s clinical rationale and relevant med- 1 ical information for the group health plan or 2 health insurance issuer to evaluate such request 3 for exception; 4 ‘‘(B) shall clearly set forth all required in- 5 formation and the specific criteria that will be 6 used to determine whether an exception is war- 7 ranted, which may require disclosure of— 8 ‘‘(i) the medical history or other 9 health records of the participant or bene- 10 ficiary demonstrating that the participant 11 or beneficiary seeking an exception— 12 ‘‘(I) has tried other drugs in- 13 cluded in the drug therapy class with- 14 out success; or 15 ‘‘(II) has taken the requested 16 drug for a clinically appropriate 17 amount of time to establish stability, 18 in relation to the condition being 19 treated and prescription guidelines 20 given by the prescribing physician; or 21 ‘‘(ii) other clinical information that 22 may be relevant to conducting the excep- 23 tion review; 24 VerDate Sep 11 2014 07:48 Mar 15, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 kjohnson on DSK79L0C42PROD with BILLS 6 •S 652 IS ‘‘(C) may not require the submission of 1 any information or supporting documentation 2 beyond what is strictly necessary to determine 3 whether any of the circumstances listed in sub- 4 section (b) exists; and 5 ‘‘(D) shall clearly outline conditions under 6 which an exception request warrants expedited 7 resolution from the group health plan or health 8 insurance issuer, pursuant to subsection (d)(2). 9 ‘‘(2) AVAILABILITY OF PROCESS INFORMA- 10 TION.—The group health plan or health insurance 11 issuer shall make information regarding the process 12 required under subsection (a) readily available on 13 the internet website of the group health plan or 14 health insurance issuer. Such information shall in- 15 clude— 16 ‘‘(A) the requirements for requesting an 17 exception to a medication step therapy protocol 18 pursuant to this section; and 19 ‘‘(B) any forms, supporting information, 20 and contact information, as appropriate. 21 ‘‘(d) TIMING FOR DETERMINATION OF EXCEP- 22 TION.—The process required under subsection (a)(1) shall 23 provide for the disposition of requests received under such 24 paragraph in accordance with the following: 25 VerDate Sep 11 2014 07:48 Mar 15, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 kjohnson on DSK79L0C42PROD with BILLS 7 •S 652 IS ‘‘(1) Subject to paragraph (2), not later than 1 72 hours after receiving an initial exception request, 2 the plan or issuer shall respond to the requesting 3 prescriber with either a determination of exception 4 eligibility or a request for additional required infor- 5 mation strictly necessary to make a determination of 6 whether the conditions specified in subsection (b) 7 are met. The plan or issuer shall respond to the re- 8 questing provider with a determination of exception 9 eligibility no later than 72 hours after receipt of the 10 additional required information. 11 ‘‘(2) In the case of a request under cir- 12 cumstances in which the applicable medication step 13 therapy protocol may seriously jeopardize the life or 14 health of the participant or beneficiary, the plan or 15 issuer shall conduct a review of the request and re- 16 spond to the requesting prescriber with either a de- 17 termination of exception eligibility or a request for 18 additional required information strictly necessary to 19 make a determination of whether the conditions 20 specified in subsection (b) are met, in accordance 21 with the following: 22 ‘‘(A) If the plan or issuer can make a de- 23 termination of exception eligibility without addi- 24 tional information, such determination shall be 25 VerDate Sep 11 2014 07:48 Mar 15, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 kjohnson on DSK79L0C42PROD with BILLS 8 •S 652 IS made on an expedited basis, and no later than 1 24 hours after receipt of such request. 2 ‘‘(B) If the plan or issuer requires addi- 3 tional information before making a determina- 4 tion of exception eligibility, the plan or issuer 5 shall respond to the requesting provider with a 6 request for such information within 24 hours of 7 the request for a determination, and shall re- 8 spond with a determination of exception eligi- 9 bility as quickly as the condition or disease re- 10 quires, and no later than 24 hours after receipt 11 of the additional required information. 12 ‘‘(e) MEDICATION STEP THERAPY PROTOCOL.—In 13 this section, the term ‘medication step therapy protocol’ 14 means a drug therapy utilization management protocol or 15 program under which a group health plan or health insur- 16 ance issuer offering group health insurance coverage of 17 prescription drugs requires a participant or beneficiary to 18 try an alternative preferred, prescription drug or drugs be- 19 fore the plan or health insurance issuer approves coverage 20 for the non-preferred drug therapy prescribed. 21 ‘‘(f) CLARIFICATION.—This section shall apply with 22 respect to any group health plan or health insurance cov- 23 erage offered in connection with such a plan that provides 24 coverage of a prescription drug pursuant to a policy that 25 VerDate Sep 11 2014 07:48 Mar 15, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 kjohnson on DSK79L0C42PROD with BILLS 9 •S 652 IS meets the definition of the term ‘medication step therapy 1 protocol’ in subsection (e), regardless of whether such pol- 2 icy is described by such group health plan or health insur- 3 ance coverage as a step therapy protocol.’’. 4 (b) CLERICAL AMENDMENT.—The table of contents 5 in section 1 of the Employee Retirement Income Security 6 Act of 1974 (29 U.S.C. 1001 et seq.) is amended by in- 7 serting after the item relating to section 713 the following 8 new items: 9 ‘‘Sec. 713A. Required exceptions process for medication step therapy proto- cols.’’. (c) EFFECTIVE DATE.— 10 (1) IN GENERAL.—The amendment made by 11 subsection (a) applies with respect to plan years be- 12 ginning with the first plan year that begins at least 13 6 months after the date of the enactment of this 14 Act. 15 (2) REGULATIONS.—Not later than 6 months 16 after the date of the enactment of this Act, the Sec- 17 retary of Labor shall issue final regulations, through 18 notice and comment rulemaking, to implement the 19 provisions of section 713A of the Employee Retire- 20 ment Income Security Act of 1974, as added by sub- 21 section (a). 22 Æ VerDate Sep 11 2014 07:48 Mar 15, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\S652.IS S652 kjohnson on DSK79L0C42PROD with BILLS