I 

116TH CONGRESS 

1ST SESSION H. R. 2279 

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 10, 2019 

Mr. RUIZ (for himself and Mr. WENSTRUP) introduced the following bill; 

which was referred to the Committee on Education and Labor 

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’’. 


pamtmann on DSKBFK8HB2PROD with BILLS
2 

•HR 2279 IH

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, if necessary) that any of 

20 the circumstances listed in subsection (b) exists, au21 thorize coverage for the prescription drug without 

22 regard to 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: 


pamtmann on DSKBFK8HB2PROD with BILLS
3 

•HR 2279 IH

1 ‘‘(1) The treatment otherwise required under 

2 the protocol, or a drug or drugs in the same phar3 macological class or having the same mechanism of 

4 action, are contraindicated or have been ineffective 

5 in the treatment of the disease or condition of the 

6 participant or beneficiary. 

7 ‘‘(2) The treatment otherwise required under 

8 the protocol is reasonably expected to be ineffective 

9 based upon— 

10 ‘‘(A) the known physical or mental charac11 teristics of the participant or beneficiary, in12 cluding medical history; and 

13 ‘‘(B) the known characteristics of such 

14 treatment. 

15 ‘‘(3) The treatment otherwise required under 

16 the protocol will cause or is likely to cause an ad17 verse reaction or other physical harm to the partici18 pant or beneficiary. 

19 ‘‘(4) The treatment otherwise required under 

20 the protocol is not in the best interest of the partici21 pant or beneficiary, based on medical necessity, be22 cause the participant or beneficiary’s use of such 

23 treatment is expected to decrease the participant or 

24 beneficiary’s ability— 


pamtmann on DSKBFK8HB2PROD with BILLS
4 

•HR 2279 IH

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 drug or drugs selected by the prescribing health care 

9 provider. 

10 ‘‘(c) CLEAR PROCESS.—The process required by sub11 section (a)(1)— 

12 ‘‘(1) shall make information regarding such 

13 process readily available on the website of the group 

14 health plan, including— 

15 ‘‘(A) the requirements for requesting an 

16 exception to a medication step therapy protocol 

17 pursuant to this section; and 

18 ‘‘(B) any necessary forms, supporting in19 formation, and contact information; and 

20 ‘‘(2) may not require the submission of any in21 formation or supporting documentation beyond what 

22 is strictly necessary to determine whether any of the 

23 circumstances listed in subsection (b) exists. 

24 ‘‘(d) TIMING FOR GRANTING EXCEPTION.—The proc25 ess required by subsection (a)(1) shall provide for the disVerDate Sep 11 2014 00:10 Apr 24, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2279.IH H2279

pamtmann on DSKBFK8HB2PROD with BILLS
5 

•HR 2279 IH

1 position of requests received under such paragraph in ac2 cordance with the following: 

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

4 as the disease or condition of the participant or ben5 eficiary requires, but no later than 3 days after the 

6 day of receipt of the request. 

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

8 medication step therapy protocol may seriously jeop9 ardize the life, health, or ability to regain maximum 

10 function of the participant or beneficiary, such a re11 quest shall be granted— 

12 ‘‘(A) on an expedited basis; and 

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

14 of such request. 

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

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

17 means a protocol or program that establishes a specific 

18 sequence in which prescription drugs that— 

19 ‘‘(1) are for a specified disease or condition; 

20 and 

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

22 patient, 

23 are covered under a pharmacy or medical benefit by a 

24 group health plan or a health insurance issuer offering 

25 group or individual health insurance coverage. 


pamtmann on DSKBFK8HB2PROD with BILLS
6 

•HR 2279 IH

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

2 respect to any group health plan (or health insurance cov3 erage offered in connection with such a plan) that provides 

4 coverage of a prescription drug pursuant to a policy that 

5 meets the definition of the term ‘medication step therapy 

6 protocol’ in subsection (e), regardless of whether such pol7 icy is described by such group health plan (or health insur8 ance coverage) as a step therapy protocol.’’. 

9 (b) TECHNICAL CORRECTION; CLERICAL CHANGE.— 

10 The table of contents in section 1 of the Employee Retire11 ment Income Security Act of 1974 (29 U.S.C. 1001 et 

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

13 section 714 the following new items: 

‘‘Sec. 715. Additional market reforms. 

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

14 (c) EFFECTIVE DATE.— 

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

16 subsection (a) applies to plan years beginning no 

17 sooner than 6 months after the date of the enact18 ment of this Act. 

19 (2) REGULATIONS.—Not later than the date 

20 that is 9 months after the date of the enactment of 

21 this Act, the Secretary of Labor shall issue final reg22 ulations, through notice and comment rulemaking, 

23 to implement the provisions of section 716 of the 


pamtmann on DSKBFK8HB2PROD with BILLS
7 

•HR 2279 IH

1 Employee Retirement Income Security Act of 1974, 

2 as added by subsection (a). 

Æ 


pamtmann on DSKBFK8HB2PROD with BILLS