I 
117TH CONGRESS 
1ST SESSION H. R. 2163 
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 
MARCH 23, 2021 
Mr. RUIZ (for himself, Mr. WENSTRUP, Mrs. MCBATH, and Mrs. MILLER- 
MEEKS) introduced the following bill; which was referred to the Com-
mittee on Education and Labor 
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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safe Step Act’’. 
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SEC. 2. REQUIRED EXCEPTIONS PROCESS FOR MEDICA-
TION STEP THERAPY PROTOCOLS. 
(a) IN GENERAL.—The Employee Retirement Income 
Security Act of 1974 is amended by inserting after section 
725 of such Act (29 U.S.C. 1185d) the following new sec-
tion: 
‘‘SEC. 726. REQUIRED EXCEPTIONS PROCESS FOR MEDICA-
TION 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 medica-
tion step therapy protocol, pursuant to subsection 
(b); and 
‘‘(2) where the participant or beneficiary or 
prescribing health care provider’s request for an ex-
ception to the medication step therapy protocols sat-
isfies 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 
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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 sub-
section (a), are any of the following: 
‘‘(1) Any treatments otherwise required under 
the protocol, or treatments in the same pharma-
cological class or having the same mechanism of ac-
tion, 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 treat-
ment otherwise required under the protocol is rea-
sonably expected to be ineffective based upon the 
documented physical or mental characteristics of the 
participant or beneficiary and the known character-
istics 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 
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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 achiev-
ing 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 dis-
ease 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 
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provider’s clinical rationale and relevant med-
ical information for the group health plan or 
health insurance issuer to evaluate such request 
for exception; 
‘‘(B) shall clearly set forth all required in-
formation and the specific criteria that will be 
used to determine whether an exception is war-
ranted, which may require disclosure of— 
‘‘(i) the medical history or other 
health records of the participant or bene-
ficiary demonstrating that the participant 
or beneficiary seeking an exception— 
‘‘(I) has tried other drugs in-
cluded in the drug therapy class with-
out 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 excep-
tion review; 
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‘‘(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 sub-
section (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
INFORMA-
TION.—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 in-
clude— 
‘‘(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
EXCEP-
TION.—The process required under subsection (a)(1) shall 
provide for the disposition of requests received under such 
paragraph in accordance with the following: 
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‘‘(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 infor-
mation strictly necessary to make a determination of 
whether the conditions specified in subsection (b) 
are met. The plan or issuer shall respond to the re-
questing 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 circum-
stances in which the applicable medication step ther-
apy 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 re-
spond to the requesting prescriber with either a de-
termination 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 de-
termination of exception eligibility without addi-
tional information, such determination shall be 
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made on an expedited basis, and no later than 
24 hours after receipt of such request. 
‘‘(B) If the plan or issuer requires addi-
tional information before making a determina-
tion 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 re-
spond with a determination of exception eligi-
bility as quickly as the condition or disease re-
quires, 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 insur-
ance issuer offering group health insurance coverage of 
prescription drugs requires a participant or beneficiary to 
try an alternative preferred, prescription drug or drugs be-
fore 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 cov-
erage offered in connection with such a plan that provides 
coverage of a prescription drug pursuant to a policy that 
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meets the definition of the term ‘medication step therapy 
protocol’ in subsection (e), regardless of whether such pol-
icy is described by such group health plan or health insur-
ance 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 in-
serting after the item relating to section 725 the following 
new items: 
‘‘Sec. 726. 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 be-
ginning 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 Sec-
retary of Labor shall issue final regulations, through 
notice and comment rulemaking, to implement the 
provisions of section 726 of the Employee Retire-
ment Income Security Act of 1974, as added by sub-
section (a). 
Æ 
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