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 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 ‘‘Restoring the Patient’s 

5 Voice Act of 2017’’. 


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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 

5 715 of such Act (29 U.S.C. 1185d) the following new sec6 tion: 

7 ‘‘SEC. 716. REQUIRED EXCEPTIONS PROCESS FOR MEDICA8 TION 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 process for a participant 

15 or beneficiary (or the prescribing health care pro16 vider) to request an exception to such medication 

17 step therapy protocol; and 

18 ‘‘(2) if such a request demonstrates through 

19 supporting documentation that any of the cir20 cumstances listed in subsection (b) exists, authorize 

21 coverage for the prescription drug without regard to 

22 such medication step therapy protocol. 

23 ‘‘(b) EXPEDITED APPROVAL.—The circumstances 

24 warranting an exception to a medication step therapy pro25 tocol, pursuant to a request under subsection (a), are any 

26 of the following: 


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1 ‘‘(1) The treatment otherwise required under 

2 the protocol, or a drug or drugs in the same phar3 macological class, are contraindicated or have been 

4 ineffective in the treatment of the disease or condi5 tion of the participant or beneficiary. 

6 ‘‘(2) The treatment otherwise required under 

7 the protocol is reasonably expected to be ineffective 

8 based upon— 

9 ‘‘(A) the known physical or mental charac10 teristics of the participant or beneficiary, in11 cluding medical history; and 

12 ‘‘(B) the known characteristics of such 

13 treatment. 

14 ‘‘(3) The treatment otherwise required under 

15 the protocol will cause or is likely to cause an ad16 verse reaction or other physical harm to the partici17 pant or beneficiary. 

18 ‘‘(4) The treatment otherwise required under 

19 the protocol is not in the best interest of the partici20 pant or beneficiary, based on medical necessity, be21 cause the participant or beneficiary’s use of such 

22 treatment is expected to decrease the participant or 

23 beneficiary’s ability— 


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1 ‘‘(A) to achieve or maintain reasonable and 

2 safe functional ability in performing daily ac3 tivities or occupational responsibilities; or 

4 ‘‘(B) to adhere to the treatment plan as 

5 defined by the prescribing health care provider. 

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

7 his or her disease or condition on the prescription 

8 drugs selected by the prescribing health care pro9 vider. 

10 ‘‘(c) CLEAR PROCESS.—The process required by sub11 section (a)(1) shall make information regarding such proc12 ess readily available on the website of the group health 

13 plan, including— 

14 ‘‘(1) the requirements for requesting an excep15 tion to a medication step therapy protocol pursuant 

16 to this section; and 

17 ‘‘(2) any necessary forms and contact informa18 tion. 

19 ‘‘(d) TIMING FOR GRANTING EXCEPTION.—The proc20 ess required by subsection (a)(1) shall provide for the dis21 position of requests received under such paragraph in ac22 cordance with the following: 

23 ‘‘(1) Such a request shall be granted as quickly 

24 as the disease or condition of the participant or benVerDate Sep 11 2014 23:31 Apr 17, 2017 Jkt 069200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2077.IH H2077

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1 eficiary requires, but no later than 3 days after the 

2 day of receipt of the request. 

3 ‘‘(2) For circumstances in which the applicable 

4 medication step therapy protocol may seriously jeop5 ardize the life, health, or ability to regain maximum 

6 function of the participant or beneficiary, such a re7 quest shall be granted— 

8 ‘‘(A) on an expedited basis; and 

9 ‘‘(B) no later than 24 hours after receipt 

10 of such request. 

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

12 this section, the term ‘step therapy protocol’ means a pro13 tocol or program that establishes a specific sequence in 

14 which prescription drugs that— 

15 ‘‘(1) are for a specified disease or condition, 

16 and 

17 ‘‘(2) are medically necessary for a particular 

18 patient, 

19 are covered under a pharmacy or medical benefit by a 

20 group health plan or a health insurance issuer offering 

21 group or individual health insurance coverage.’’. 

22 (b) TECHNICAL CORRECTION; CLERICAL CHANGE.— 

23 The table of contents in section 1 of the Employee Retire24 ment Income Security Act of 1974 (29 U.S.C. 1001 et 


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1 seq.) is amended by inserting after the item relating to 

2 section 714 the following new items: 

Sec. 715. Additional market reforms. 

Sec. 716. Required exceptions process for medication step therapy protocols. 

3 (c) EFFECTIVE DATE.—The amendment made by 

4 subsection (a) applies to plan years beginning no sooner 

5 than 6 months after the date of enactment of this Act. 

Æ 


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