‘‘(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 in the 
relevant plan materials, including the summary of 
benefits and, if available, on the website of the group 
health plan or health insurance issuer. Such infor-
mation 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
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: 
‘‘(1) Subject to paragraph (2), not later than 
72 hours after receiving an initial exception request, 
the plan or issuer shall respond to the participant or 
beneficiary and, if applicable, the requesting pre-
scriber with either a determination of exception eligi-
bility or a request for additional required informa-
tion strictly necessary to make a determination of 
whether the conditions specified in subsection (b) 
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are met. The plan or issuer shall respond to the par-
ticipant or beneficiary and, if applicable, the request-
ing prescriber, with a determination of exception eli-
gibility no later than 72 hours after receipt of the 
additional required information. 
‘‘(2) In the case of a request under cir-
cumstances in which the applicable medication step 
therapy protocol may seriously jeopardize the life or 
health of the participant or beneficiary, may jeop-
ardize the ability of the participant or beneficiary to 
regain maximum function, or may subject the partic-
ipant or beneficiary to severe pain that cannot be 
adequately managed without the treatment that is 
the subject of the request, the plan or issuer shall 
conduct a review of the request and respond to the 
participant or beneficiary and, if applicable, the re-
questing prescriber, with either a determination of 
exception eligibility or a request for additional re-
quired information strictly necessary to make a de-
termination of whether the conditions specified in 
subsection (b) are met, in accordance with the fol-
lowing: 
‘‘(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 participant or beneficiary 
and, if applicable, the requesting prescriber, 
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 re-
ceipt of the additional required information. 
‘‘(e) DURATION OF A GRANT.—If an exception to a 
medication step therapy protocol is granted under this sec-
tion to a participant or beneficiary, coverage for the re-
quested drug shall remain in effect with respect to such 
participant or beneficiary for not less than one year. 
‘‘(f) 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-
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fore the plan or health insurance issuer approves coverage 
for the non-preferred drug therapy prescribed. 
‘‘(g) 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 
meets the definition of the term ‘medication step therapy 
protocol’ in subsection (f), regardless of whether such pol-
icy is described by such group health plan or health insur-
ance coverage as a step therapy protocol. 
‘‘(h) REPORTING.— 
‘‘(1) REPORTING
TO
THE
SECRETARY.—Not 
later than 3 years after the date of enactment of the 
Safe Step Act and not later than October 1 of each 
year thereafter, each group health plan and health 
insurance issuer offering group health insurance cov-
erage shall report to the Secretary, in such manner 
as the Secretary shall require, the following: 
‘‘(A) The number of step therapy exception 
requests received for each exception cir-
cumstance described in paragraphs (1) through 
(6) of subsection (b), and the numbers of such 
requests for each such circumstance that 
were— 
‘‘(i) approved; 
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‘‘(ii) denied, and the reasons for the 
denials; 
‘‘(iii) initially denied and appealed; 
and 
‘‘(iv) initially denied and then subse-
quently reversed by internal appeals or ex-
ternal reviews. 
‘‘(B) The number of times a plan or issuer 
requested additional information in response to 
a step therapy exception request, by exception 
circumstance described in paragraphs (1) 
through (6) of subsection (b). 
‘‘(C) The number of exception requests 
submitted by participants or beneficiaries, and 
the number of exception requests submitted by 
prescribers, by medical specialty. 
‘‘(D) The medical conditions for which 
participants and beneficiaries were granted ex-
ceptions due to the likelihood that switching 
from a prescription drug will likely cause an ad-
verse reaction by, or physical or mental harm 
to, the participant or beneficiary, as described 
in subsection (b)(3). 
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‘‘(E) The entities responsible for providing 
pharmacy benefit management services for the 
group health plan or health insurance coverage. 
‘‘(2) INFORMATION.—A group health plan or 
health insurance issuer offering group health insur-
ance coverage shall not enter into a contract with a 
third-party administrator or an entity providing 
pharmacy benefit management services on behalf of 
the plan or coverage that prevents the plan or issuer 
from obtaining from the third-party administrator or 
the entity providing pharmacy benefit management 
services any information needed for the plan or 
issuer to comply with the reporting requirements 
under paragraph (1). 
‘‘(3) REPORTS TO CONGRESS.—Not later than 
3 years after the date of enactment of the Safe Step 
Act, and not later than October 1 of each year 
thereafter, the Secretary shall submit to Congress, 
and make publicly available, a report that contains 
a summary and analysis of the information reported 
under paragraph (1), including an analysis of, with 
respect to requests for exceptions under this section, 
approvals, and denials, including the reasons for de-
nials; appeals and external reviews; and trends, if 
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any, in exception requests by medical specialty or 
medical condition.’’. 
(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 713 the following 
new item: 
‘‘Sec. 713A. Required exceptions process for medication step therapy proto-
cols.’’. 
(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 713A of the Employee Retire-
ment Income Security Act of 1974, as added by sub-
section (a). 
Æ 
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