Safe Step Act

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 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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Safe Step Act’’. 4 VerDate Sep 11 2014 00:10 Apr 24, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2279.IH H2279 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 2279 IH SEC. 2. REQUIRED EXCEPTIONS PROCESS FOR MEDICA- 1 TION STEP THERAPY PROTOCOLS. 2 (a) IN GENERAL.—The Employee Retirement Income 3 Security Act of 1974 is amended by inserting after section 4 715 of such Act (29 U.S.C. 1185d) the following new sec- 5 tion: 6 ‘‘SEC. 716. REQUIRED EXCEPTIONS PROCESS FOR MEDICA- 7 TION STEP THERAPY PROTOCOLS. 8 ‘‘(a) IN GENERAL.—In the case of a group health 9 plan (or health insurance coverage offered in connection 10 with such a plan) that provides coverage of a prescription 11 drug pursuant to a medication step therapy protocol, the 12 plan or coverage shall— 13 ‘‘(1) implement a clear process for a participant 14 or beneficiary (or the prescribing health care pro- 15 vider) to request an exception to such medication 16 step therapy protocol; and 17 ‘‘(2) if such a request demonstrates (through 18 supporting documentation, if necessary) that any of 19 the circumstances listed in subsection (b) exists, au- 20 thorize coverage for the prescription drug without 21 regard to such medication step therapy protocol. 22 ‘‘(b) EXPEDITED APPROVAL.—The circumstances 23 warranting an exception to a medication step therapy pro- 24 tocol, pursuant to a request under subsection (a), are any 25 of the following: 26 VerDate Sep 11 2014 00:10 Apr 24, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2279.IH H2279 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 2279 IH ‘‘(1) The treatment otherwise required under 1 the protocol, or a drug or drugs in the same phar- 2 macological class or having the same mechanism of 3 action, are contraindicated or have been ineffective 4 in the treatment of the disease or condition of the 5 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 charac- 10 teristics of the participant or beneficiary, in- 11 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 ad- 16 verse reaction or other physical harm to the partici- 17 pant or beneficiary. 18 ‘‘(4) The treatment otherwise required under 19 the protocol is not in the best interest of the partici- 20 pant or beneficiary, based on medical necessity, be- 21 cause the participant or beneficiary’s use of such 22 treatment is expected to decrease the participant or 23 beneficiary’s ability— 24 VerDate Sep 11 2014 00:10 Apr 24, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2279.IH H2279 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 2279 IH ‘‘(A) to achieve or maintain reasonable and 1 safe functional ability in performing daily ac- 2 tivities or occupational responsibilities; or 3 ‘‘(B) to adhere to the treatment plan as 4 defined by the prescribing health care provider. 5 ‘‘(5) The participant or beneficiary is stable for 6 his or her disease or condition on the prescription 7 drug or drugs selected by the prescribing health care 8 provider. 9 ‘‘(c) CLEAR PROCESS.—The process required by sub- 10 section (a)(1)— 11 ‘‘(1) shall make information regarding such 12 process readily available on the website of the group 13 health plan, including— 14 ‘‘(A) the requirements for requesting an 15 exception to a medication step therapy protocol 16 pursuant to this section; and 17 ‘‘(B) any necessary forms, supporting in- 18 formation, and contact information; and 19 ‘‘(2) may not require the submission of any in- 20 formation or supporting documentation beyond what 21 is strictly necessary to determine whether any of the 22 circumstances listed in subsection (b) exists. 23 ‘‘(d) TIMING FOR GRANTING EXCEPTION.—The proc- 24 ess required by subsection (a)(1) shall provide for the dis- 25 VerDate 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 position of requests received under such paragraph in ac- 1 cordance with the following: 2 ‘‘(1) Such a request shall be granted as quickly 3 as the disease or condition of the participant or ben- 4 eficiary requires, but no later than 3 days after the 5 day of receipt of the request. 6 ‘‘(2) For circumstances in which the applicable 7 medication step therapy protocol may seriously jeop- 8 ardize the life, health, or ability to regain maximum 9 function of the participant or beneficiary, such a re- 10 quest shall be granted— 11 ‘‘(A) on an expedited basis; and 12 ‘‘(B) no later than 24 hours after receipt 13 of such request. 14 ‘‘(e) MEDICATION STEP THERAPY PROTOCOL.—In 15 this section, the term ‘medication step therapy protocol’ 16 means a protocol or program that establishes a specific 17 sequence in which prescription drugs that— 18 ‘‘(1) are for a specified disease or condition; 19 and 20 ‘‘(2) are medically necessary for a particular 21 patient, 22 are covered under a pharmacy or medical benefit by a 23 group health plan or a health insurance issuer offering 24 group or individual health insurance coverage. 25 VerDate Sep 11 2014 00:10 Apr 24, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2279.IH H2279 pamtmann on DSKBFK8HB2PROD with BILLS 6 •HR 2279 IH ‘‘(f) CLARIFICATION.—This section shall apply with 1 respect to any group health plan (or health insurance cov- 2 erage offered in connection with such a plan) that provides 3 coverage of a prescription drug pursuant to a policy that 4 meets the definition of the term ‘medication step therapy 5 protocol’ in subsection (e), regardless of whether such pol- 6 icy is described by such group health plan (or health insur- 7 ance coverage) as a step therapy protocol.’’. 8 (b) TECHNICAL CORRECTION; CLERICAL CHANGE.— 9 The table of contents in section 1 of the Employee Retire- 10 ment Income Security Act of 1974 (29 U.S.C. 1001 et 11 seq.) is amended by inserting after the item relating to 12 section 714 the following new items: 13 ‘‘Sec. 715. Additional market reforms. ‘‘Sec. 716. Required exceptions process for medication step therapy protocols.’’. (c) EFFECTIVE DATE.— 14 (1) IN GENERAL.—The amendment made by 15 subsection (a) applies to plan years beginning no 16 sooner than 6 months after the date of the enact- 17 ment of this Act. 18 (2) REGULATIONS.—Not later than the date 19 that is 9 months after the date of the enactment of 20 this Act, the Secretary of Labor shall issue final reg- 21 ulations, through notice and comment rulemaking, 22 to implement the provisions of section 716 of the 23 VerDate Sep 11 2014 00:10 Apr 24, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2279.IH H2279 pamtmann on DSKBFK8HB2PROD with BILLS 7 •HR 2279 IH Employee Retirement Income Security Act of 1974, 1 as added by subsection (a). 2 Æ VerDate Sep 11 2014 00:10 Apr 24, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H2279.IH H2279 pamtmann on DSKBFK8HB2PROD with BILLS