II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Safe Step Act’’. 


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1 SEC. 2. REQUIRED EXCEPTIONS PROCESS FOR MEDICA2 TION STEP THERAPY PROTOCOLS. 

3 (a) IN GENERAL.—The Employee Retirement Income 

4 Security Act of 1974 is amended by inserting after section 

5 713 of such Act (29 U.S.C. 1185b) the following new sec6 tion: 

7 ‘‘SEC. 713A. REQUIRED EXCEPTIONS PROCESS FOR MEDI8 CATION STEP THERAPY PROTOCOLS. 

9 ‘‘(a) IN GENERAL.—In the case of a group health 

10 plan or health insurance coverage offered in connection 

11 with such a plan that provides coverage of a prescription 

12 drug pursuant to a medication step therapy protocol, the 

13 plan or coverage shall— 

14 ‘‘(1) implement a clear and transparent process 

15 for a participant or beneficiary (or the prescribing 

16 health care provider on behalf of the participant or 

17 beneficiary) to request an exception to such medica18 tion step therapy protocol, pursuant to subsection 

19 (b); and 

20 ‘‘(2) where the participant or beneficiary or 

21 prescribing health care provider’s request for an ex22 ception to the medication step therapy protocols sat23 isfies the criteria and requirements of subsection (b), 

24 cover the requested drug in accordance with the 

25 terms established by the health plan or coverage for 

26 patient cost-sharing rates or amounts at the time of 


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1 the participant’s or beneficiary’s enrollment in the 

2 health plan or health insurance coverage. 

3 ‘‘(b) CIRCUMSTANCES FOR EXCEPTION APPROVAL.— 

4 The circumstances requiring an exception to a medication 

5 step therapy protocol, pursuant to a request under sub6 section (a), are any of the following: 

7 ‘‘(1) Any treatments otherwise required under 

8 the protocol, or treatments in the same pharma9 cological class or having the same mechanism of ac10 tion, have been ineffective in the treatment of the 

11 disease or condition of the participant or beneficiary, 

12 when prescribed consistent with clinical indications, 

13 clinical guidelines, or other peer-reviewed evidence. 

14 ‘‘(2) Delay of effective treatment would lead to 

15 severe or irreversible consequences, and the treat16 ment otherwise required under the protocol is rea17 sonably expected to be ineffective based upon the 

18 documented physical or mental characteristics of the 

19 participant or beneficiary and the known character20 istics of such treatment. 

21 ‘‘(3) Any treatments otherwise required under 

22 the protocol are contraindicated for the participant 

23 or beneficiary or have caused, or are likely to cause, 

24 based on clinical, peer-reviewed evidence, an adverse 


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1 reaction or other physical harm to the participant or 

2 beneficiary. 

3 ‘‘(4) Any treatment otherwise required under 

4 the protocol has prevented, will prevent, or is likely 

5 to prevent a participant or beneficiary from achiev6 ing or maintaining reasonable and safe functional 

7 ability in performing occupational responsibilities or 

8 activities of daily living (as defined in section 

9 441.505 of title 42, Code of Federal Regulations (or 

10 successor regulations)). 

11 ‘‘(5) The participant or beneficiary is stable for 

12 his or her disease or condition on the prescription 

13 drug or drugs selected by the prescribing health care 

14 provider and has previously received approval for 

15 coverage of the relevant drug or drugs for the dis16 ease or condition by any group health plan or health 

17 insurance issuer. 

18 ‘‘(6) Other circumstances, as determined by the 

19 Secretary. 

20 ‘‘(c) REQUIREMENT OF A CLEAR PROCESS.— 

21 ‘‘(1) IN GENERAL.—The process required by 

22 subsection (a)— 

23 ‘‘(A) shall provide the prescribing health 

24 care provider or beneficiary or designated third25 party advocate an opportunity to present such 


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1 provider’s clinical rationale and relevant med2 ical information for the group health plan or 

3 health insurance issuer to evaluate such request 

4 for exception; 

5 ‘‘(B) shall clearly set forth all required in6 formation and the specific criteria that will be 

7 used to determine whether an exception is war8 ranted, which may require disclosure of— 

9 ‘‘(i) the medical history or other 

10 health records of the participant or bene11 ficiary demonstrating that the participant 

12 or beneficiary seeking an exception— 

13 ‘‘(I) has tried other drugs in14 cluded in the drug therapy class with15 out success; or 

16 ‘‘(II) has taken the requested 

17 drug for a clinically appropriate 

18 amount of time to establish stability, 

19 in relation to the condition being 

20 treated and prescription guidelines 

21 given by the prescribing physician; or 

22 ‘‘(ii) other clinical information that 

23 may be relevant to conducting the excep24 tion review; 


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1 ‘‘(C) may not require the submission of 

2 any information or supporting documentation 

3 beyond what is strictly necessary to determine 

4 whether any of the circumstances listed in sub5 section (b) exists; and 

6 ‘‘(D) shall clearly outline conditions under 

7 which an exception request warrants expedited 

8 resolution from the group health plan or health 

9 insurance issuer, pursuant to subsection (d)(2). 

10 ‘‘(2) AVAILABILITY OF PROCESS INFORMA11 TION.—The group health plan or health insurance 

12 issuer shall make information regarding the process 

13 required under subsection (a) readily available on 

14 the internet website of the group health plan or 

15 health insurance issuer. Such information shall in16 clude— 

17 ‘‘(A) the requirements for requesting an 

18 exception to a medication step therapy protocol 

19 pursuant to this section; and 

20 ‘‘(B) any forms, supporting information, 

21 and contact information, as appropriate. 

22 ‘‘(d) TIMING FOR DETERMINATION OF EXCEP23 TION.—The process required under subsection (a)(1) shall 

24 provide for the disposition of requests received under such 

25 paragraph in accordance with the following: 


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1 ‘‘(1) Subject to paragraph (2), not later than 

2 72 hours after receiving an initial exception request, 

3 the plan or issuer shall respond to the requesting 

4 prescriber with either a determination of exception 

5 eligibility or a request for additional required infor6 mation strictly necessary to make a determination of 

7 whether the conditions specified in subsection (b) 

8 are met. The plan or issuer shall respond to the re9 questing provider with a determination of exception 

10 eligibility no later than 72 hours after receipt of the 

11 additional required information. 

12 ‘‘(2) In the case of a request under cir13 cumstances in which the applicable medication step 

14 therapy protocol may seriously jeopardize the life or 

15 health of the participant or beneficiary, the plan or 

16 issuer shall conduct a review of the request and re17 spond to the requesting prescriber with either a de18 termination of exception eligibility or a request for 

19 additional required information strictly necessary to 

20 make a determination of whether the conditions 

21 specified in subsection (b) are met, in accordance 

22 with the following: 

23 ‘‘(A) If the plan or issuer can make a de24 termination of exception eligibility without addi25 tional information, such determination shall be 


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1 made on an expedited basis, and no later than 

2 24 hours after receipt of such request. 

3 ‘‘(B) If the plan or issuer requires addi4 tional information before making a determina5 tion of exception eligibility, the plan or issuer 

6 shall respond to the requesting provider with a 

7 request for such information within 24 hours of 

8 the request for a determination, and shall re9 spond with a determination of exception eligi10 bility as quickly as the condition or disease re11 quires, and no later than 24 hours after receipt 

12 of the additional required information. 

13 ‘‘(e) MEDICATION STEP THERAPY PROTOCOL.—In 

14 this section, the term ‘medication step therapy protocol’ 

15 means a drug therapy utilization management protocol or 

16 program under which a group health plan or health insur17 ance issuer offering group health insurance coverage of 

18 prescription drugs requires a participant or beneficiary to 

19 try an alternative preferred, prescription drug or drugs be20 fore the plan or health insurance issuer approves coverage 

21 for the non-preferred drug therapy prescribed. 

22 ‘‘(f) CLARIFICATION.—This section shall apply with 

23 respect to any group health plan or health insurance cov24 erage offered in connection with such a plan that provides 

25 coverage of a prescription drug pursuant to a policy that 


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1 meets the definition of the term ‘medication step therapy 

2 protocol’ in subsection (e), regardless of whether such pol3 icy is described by such group health plan or health insur4 ance coverage as a step therapy protocol.’’. 

5 (b) CLERICAL AMENDMENT.—The table of contents 

6 in section 1 of the Employee Retirement Income Security 

7 Act of 1974 (29 U.S.C. 1001 et seq.) is amended by in8 serting after the item relating to section 713 the following 

9 new items: 

‘‘Sec. 713A. Required exceptions process for medication step therapy protocols.’’. 

10 (c) EFFECTIVE DATE.— 

11 (1) IN GENERAL.—The amendment made by 

12 subsection (a) applies with respect to plan years be13 ginning with the first plan year that begins at least 

14 6 months after the date of the enactment of this 

15 Act. 

16 (2) REGULATIONS.—Not later than 6 months 

17 after the date of the enactment of this Act, the Sec18 retary of Labor shall issue final regulations, through 

19 notice and comment rulemaking, to implement the 

20 provisions of section 713A of the Employee Retire21 ment Income Security Act of 1974, as added by sub22 section (a). 

Æ 


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