CLINICAL TREATMENT Act

I 116TH CONGRESS 1ST SESSION H. R. 913 To amend title XIX of the Social Security Act to promote access to life- saving therapies for Medicaid enrollees by ensuring coverage of routine patient costs for items and services furnished in connection with partici- pation in qualifying clinical trials, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JANUARY 30, 2019 Mr. LUJA´N (for himself and Mr. BILIRAKIS) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend title XIX of the Social Security Act to promote access to life-saving therapies for Medicaid enrollees by ensuring coverage of routine patient costs for items and services furnished in connection with participation in qualifying clinical trials, 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 ‘‘Covering Life-saving 4 Investigations Needed in Cancer and Other Life-threat- 5 ening Conditions through Timely use of Resources for 6 Easy and Affordable Treatment from Medicaid for Enroll- 7 VerDate Sep 11 2014 21:12 Feb 11, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H913.IH H913 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 913 IH ees in Need Today Act’’ or the ‘‘CLINICAL TREAT- 1 MENT Act’’. 2 SEC. 2. PROMOTING ACCESS TO LIFE-SAVING THERAPIES 3 FOR MEDICAID ENROLLEES BY ENSURING 4 COVERAGE OF ROUTINE PATIENT COSTS FOR 5 ITEMS AND SERVICES FURNISHED IN CON- 6 NECTION WITH PARTICIPATION IN QUALI- 7 FYING CLINICAL TRIALS. 8 (a) IN GENERAL.—Section 1905 of the Social Secu- 9 rity Act (42 U.S.C. 1396d) is amended— 10 (1) in subsection (a)— 11 (A) in paragraph (29), by striking ‘‘and’’ 12 at the end; 13 (B) by redesignating paragraph (30) as 14 paragraph (31); and 15 (C) by inserting after paragraph (29) the 16 following new paragraph: 17 ‘‘(30) subject to subsection (ff), routine patient 18 costs for items and services furnished in connection 19 with participation in a qualifying clinical trial (as 20 defined in such subsection); and’’; and 21 (2) by adding at the end the following new sub- 22 section: 23 ‘‘(ff)(1) ROUTINE PATIENT COSTS.—For purposes of 24 subsection (a)(30), with respect to a State and an indi- 25 VerDate Sep 11 2014 21:12 Feb 11, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H913.IH H913 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 913 IH vidual enrolled under the State plan (or a waiver of such 1 plan) who participates in a qualifying clinical trial, routine 2 patient costs— 3 ‘‘(A) include any item or service provided to the 4 individual under the qualifying clinical trial, includ- 5 ing any item or service provided to prevent, diag- 6 nose, or treat complications resulting from such par- 7 ticipation, to the extent that the provision of such an 8 item or service to the individual outside the course 9 of such participation would otherwise be covered 10 under the State plan (or waiver); and 11 ‘‘(B) does not include— 12 ‘‘(i) the investigational item or service that 13 is the subject of the qualifying clinical trial; or 14 ‘‘(ii) an item or service that is provided to 15 the individual solely to satisfy data collection 16 and analysis needs for the qualifying clinical 17 trial and is not used in the direct clinical man- 18 agement of the individual. 19 ‘‘(2) QUALIFYING CLINICAL TRIAL DEFINED.— 20 ‘‘(A) IN GENERAL.—For purposes of this sub- 21 section and subsection (a)(30), the term ‘qualifying 22 clinical trial’ means a phase I, phase II, phase III, 23 or phase IV clinical trial that is conducted in rela- 24 tion to the prevention, detection, or treatment of 25 VerDate Sep 11 2014 21:12 Feb 11, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H913.IH H913 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 913 IH cancer or any other life-threatening condition and is 1 described in any of the following clauses: 2 ‘‘(i) The study or investigation is approved 3 or funded (which may include funding through 4 in-kind contributions) by one or more of the fol- 5 lowing: 6 ‘‘(I) The National Institutes of 7 Health. 8 ‘‘(II) The Centers for Disease Control 9 and Prevention. 10 ‘‘(III) The Agency for Healthcare Re- 11 search and Quality. 12 ‘‘(IV) The Centers for Medicare & 13 Medicaid Services. 14 ‘‘(V) A cooperative group or center of 15 any of the entities described in subclauses 16 (I) through (IV) or the Department of De- 17 fense or the Department of Veterans Af- 18 fairs. 19 ‘‘(VI) A qualified non-governmental 20 research entity identified in the guidelines 21 issued by the National Institutes of Health 22 for center support grants. 23 VerDate Sep 11 2014 21:12 Feb 11, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H913.IH H913 pamtmann on DSKBFK8HB2PROD with BILLS 5 •HR 913 IH ‘‘(VII) Any of the following if the con- 1 ditions described in subparagraph (B) are 2 met: 3 ‘‘(aa) The Department of Vet- 4 erans Affairs. 5 ‘‘(bb) The Department of De- 6 fense. 7 ‘‘(cc) The Department of Energy. 8 ‘‘(ii) The clinical trial is conducted under 9 an investigational new drug application re- 10 viewed by the Food and Drug Administration. 11 ‘‘(iii) The clinical trial is a drug trial that 12 is exempt from having such an investigational 13 new drug application. 14 ‘‘(B) CONDITIONS.—For purposes of subpara- 15 graph (A)(i)(VII), the conditions described in this 16 subparagraph, with respect to a clinical trial ap- 17 proved or funded by an entity described in such sub- 18 paragraph (A)(i)(VII), are that the clinical trial has 19 been reviewed and approved through a system of 20 peer review that the Secretary determines— 21 ‘‘(i) to be comparable to the system of peer 22 review of studies and investigations used by the 23 National Institutes of Health; and 24 VerDate Sep 11 2014 21:12 Feb 11, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H913.IH H913 pamtmann on DSKBFK8HB2PROD with BILLS 6 •HR 913 IH ‘‘(ii) assures unbiased review of the highest 1 scientific standards by qualified individuals with 2 no interest in the outcome of the review. 3 ‘‘(3) LIFE-THREATENING CONDITION DEFINED.— 4 For purposes of this subsection, the term ‘life-threatening 5 condition’ means any disease or condition from which the 6 likelihood of death is probable unless the course of the dis- 7 ease or condition is interrupted. 8 ‘‘(4) COVERAGE DETERMINATION REQUIREMENTS.— 9 A determination with respect to coverage under subsection 10 (a)(30) for an individual participating in a qualifying clin- 11 ical trial— 12 ‘‘(A) shall be expedited and completed within 13 48 hours; 14 ‘‘(B) shall be made without limitation on the 15 geographic location or network affiliation of the 16 health care provider treating such individual or the 17 principal investigator of the qualifying clinical trial; 18 ‘‘(C) shall be based solely on attestation regard- 19 ing the appropriateness of the qualifying clinical 20 trial by the health care provider and principal inves- 21 tigator described in subparagraph (B), which shall 22 be made using a streamlined, uniform form devel- 23 oped for national use by the Secretary and that in- 24 cludes the option to reference information regarding 25 VerDate Sep 11 2014 21:12 Feb 11, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H913.IH H913 pamtmann on DSKBFK8HB2PROD with BILLS 7 •HR 913 IH the qualifying clinical trial that is publicly available 1 on a website maintained by the Secretary, such as 2 clinicaltrials.gov (or a successor website); and 3 ‘‘(D) shall not require submission of the proto- 4 cols of the qualifying clinical trial, or any other doc- 5 umentation that may be proprietary or determined 6 by the Secretary to be burdensome to provide.’’. 7 (b) REQUIRING MANDATORY COVERAGE UNDER 8 STATE PLAN.—Section 1902(a)(10)(A) of such Act is 9 amended, in the matter preceding clause (i), by striking 10 ‘‘and (29)’’ and inserting ‘‘(29), and (30)’’. 11 (c) ENSURING ACCESS FOR MEDICAID EXPANSION 12 POPULATION.—Section 1937(b)(5) of such Act is amend- 13 ed by inserting before the period at the end the following: 14 ‘‘, and beginning January 1, 2020, coverage of routine pa- 15 tient costs for items and services furnished in connection 16 with participation in a qualifying clinical trial (as defined 17 in section 1905(ff))’’. 18 (d) EFFECTIVE DATE.— 19 (1) IN GENERAL.—The amendments made by 20 this section shall apply with respect to items and 21 services furnished on or after the date of the enact- 22 ment of this Act. 23 (2) EXCEPTION FOR STATE LEGISLATION.—In 24 the case of a State plan under title XIX of the So- 25 VerDate Sep 11 2014 21:12 Feb 11, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H913.IH H913 pamtmann on DSKBFK8HB2PROD with BILLS 8 •HR 913 IH cial Security Act (42 U.S.C. 1396 et seq.) that the 1 Secretary of Health and Human Services determines 2 requires State legislation in order for the respective 3 plan to meet any requirement imposed by amend- 4 ments made by this section, the respective plan shall 5 not be regarded as failing to comply with the re- 6 quirements of such title solely on the basis of its 7 failure to meet such an additional requirement be- 8 fore the first day of the first calendar quarter begin- 9 ning after the close of the first regular session of the 10 State legislature that begins after the date of the en- 11 actment of this Act. For purposes of the previous 12 sentence, in the case of a State that has a 2-year 13 legislative session, each year of the session shall be 14 considered to be a separate regular session of the 15 State legislature. 16 Æ VerDate Sep 11 2014 21:12 Feb 11, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\H913.IH H913 pamtmann on DSKBFK8HB2PROD with BILLS