I 
115TH CONGRESS 
1ST SESSION H. R. 2077 
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 
APRIL 6, 2017 
Mr. WENSTRUP (for himself and Mr. RUIZ) introduced the following bill; 
which was referred to the Committee on Education and the Workforce 
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 ‘‘Restoring the Patient’s 
Voice Act of 2017’’. 
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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 
715 of such Act (29 U.S.C. 1185d) the following new sec-
tion: 
‘‘SEC. 716. 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 process for a participant 
or beneficiary (or the prescribing health care pro-
vider) to request an exception to such medication 
step therapy protocol; and 
‘‘(2) if such a request demonstrates through 
supporting documentation that any of the cir-
cumstances 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 pro-
tocol, pursuant to a request under subsection (a), are any 
of the following: 
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‘‘(1) The treatment otherwise required under 
the protocol, or a drug or drugs in the same phar-
macological class, are contraindicated or have been 
ineffective in the treatment of the disease or condi-
tion 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 charac-
teristics of the participant or beneficiary, in-
cluding 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 ad-
verse reaction or other physical harm to the partici-
pant or beneficiary. 
‘‘(4) The treatment otherwise required under 
the protocol is not in the best interest of the partici-
pant or beneficiary, based on medical necessity, be-
cause the participant or beneficiary’s use of such 
treatment is expected to decrease the participant or 
beneficiary’s ability— 
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‘‘(A) to achieve or maintain reasonable and 
safe functional ability in performing daily ac-
tivities 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 
drugs selected by the prescribing health care pro-
vider. 
‘‘(c) CLEAR PROCESS.—The process required by sub-
section (a)(1) shall make information regarding such proc-
ess readily available on the website of the group health 
plan, including— 
‘‘(1) the requirements for requesting an excep-
tion to a medication step therapy protocol pursuant 
to this section; and 
‘‘(2) any necessary forms and contact informa-
tion. 
‘‘(d) TIMING FOR GRANTING EXCEPTION.—The proc-
ess required by subsection (a)(1) shall provide for the dis-
position of requests received under such paragraph in ac-
cordance with the following: 
‘‘(1) Such a request shall be granted as quickly 
as the disease or condition of the participant or ben-
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eficiary 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 jeop-
ardize the life, health, or ability to regain maximum 
function of the participant or beneficiary, such a re-
quest 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 ‘step therapy protocol’ means a pro-
tocol 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.’’. 
(b) TECHNICAL CORRECTION; CLERICAL CHANGE.— 
The table of contents in section 1 of the Employee Retire-
ment Income Security Act of 1974 (29 U.S.C. 1001 et 
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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.—The amendment made by 
subsection (a) applies to plan years beginning no sooner 
than 6 months after the date of enactment of this Act. 
Æ 
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