CLINICAL TREATMENT Act

II 116TH CONGRESS 2D SESSION S. 4742 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 SENATE OF THE UNITED STATES SEPTEMBER 29, 2020 Mr. BURR (for himself and Mr. CARDIN) introduced the following bill; which was read twice and referred to the Committee on Finance 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 18:30 Oct 20, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4742.IS S4742 2 •S 4742 IS 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 (gg), 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 ‘‘(gg)(1) ROUTINE PATIENT COSTS.—For purposes 24 of subsection (a)(30), with respect to a State and an indi- 25 VerDate Sep 11 2014 02:37 Oct 17, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4742.IS S4742 3 •S 4742 IS 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— 15 ‘‘(I) provided to the individual solely 16 to satisfy data collection and analysis 17 needs for the qualifying clinical trial and is 18 not used in the direct clinical management 19 of the individual; and 20 ‘‘(II) not otherwise covered under the 21 State plan or waiver. 22 ‘‘(2) QUALIFYING CLINICAL TRIAL DEFINED.— 23 ‘‘(A) IN GENERAL.—For purposes of this sub- 24 section and subsection (a)(30), the term ‘qualifying 25 VerDate Sep 11 2014 02:37 Oct 17, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4742.IS S4742 4 •S 4742 IS clinical trial’ means a clinical trial (in any clinical 1 phase of development) that is conducted in relation 2 to the prevention, detection, or treatment of any se- 3 rious or life-threatening disease or condition and is 4 described in any of the following clauses: 5 ‘‘(i) The study or investigation is approved 6 or funded (which may include funding through 7 in-kind contributions) by one or more of the fol- 8 lowing: 9 ‘‘(I) The National Institutes of 10 Health. 11 ‘‘(II) The Centers for Disease Control 12 and Prevention. 13 ‘‘(III) The Agency for Healthcare Re- 14 search and Quality. 15 ‘‘(IV) The Centers for Medicare & 16 Medicaid Services. 17 ‘‘(V) A cooperative group or center of 18 any of the entities described in subclauses 19 (I) through (IV) or the Department of De- 20 fense or the Department of Veterans Af- 21 fairs. 22 ‘‘(VI) A qualified non-governmental 23 research entity identified in the guidelines 24 VerDate Sep 11 2014 02:37 Oct 17, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4742.IS S4742 5 •S 4742 IS issued by the National Institutes of Health 1 for center support grants. 2 ‘‘(VII) Any of the following if the con- 3 ditions described in subparagraph (B) are 4 met: 5 ‘‘(aa) The Department of Vet- 6 erans Affairs. 7 ‘‘(bb) The Department of De- 8 fense. 9 ‘‘(cc) The Department of Energy. 10 ‘‘(ii) The clinical trial is conducted pursu- 11 ant to an investigational new drug exemption 12 under section 505(i) of the Federal Food, Drug, 13 and Cosmetic Act (21 U.S.C. 355(i)) or an ex- 14 emption for a biological product undergoing in- 15 vestigation under section 351(a)(3) of the Pub- 16 lic Health Service Act (42 U.S.C. 262(a)(3)). 17 ‘‘(iii) The clinical trial is a drug trial that 18 is exempt from having such an investigational 19 new drug application. 20 ‘‘(B) CONDITIONS.—For purposes of subpara- 21 graph (A)(i)(VII), the conditions described in this 22 subparagraph, with respect to a clinical trial ap- 23 proved or funded by an entity described in such sub- 24 paragraph (A)(i)(VII), are that the clinical trial has 25 VerDate Sep 11 2014 02:37 Oct 17, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4742.IS S4742 6 •S 4742 IS been reviewed and approved through a system of 1 peer review that the Secretary determines— 2 ‘‘(i) to be comparable to the system of peer 3 review of studies and investigations used by the 4 National Institutes of Health; and 5 ‘‘(ii) assures unbiased review of the highest 6 scientific standards by qualified individuals with 7 no interest in the outcome of the review. 8 ‘‘(3) 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 24 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 on attestation regarding the 19 appropriateness of the qualifying clinical trial by the 20 health care provider and principal investigator de- 21 scribed in subparagraph (B), which shall be made 22 using a streamlined, uniform form developed for na- 23 tional use by the Secretary and that includes the op- 24 tion to reference information regarding the quali- 25 VerDate Sep 11 2014 02:37 Oct 17, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4742.IS S4742 7 •S 4742 IS fying clinical trial that is publicly available on a 1 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) INCLUSION IN BENCHMARK COVERAGE.—Section 12 1937(b)(5) of such Act is amended by inserting before the 13 period at the end the following: ‘‘, and beginning January 14 1, 2020, coverage of routine patient costs for items and 15 services furnished in connection with participation in a 16 qualifying clinical trial (as defined in section 1905(gg))’’. 17 (d) EFFECTIVE DATE.— 18 (1) IN GENERAL.—The amendments made by 19 this section shall apply with respect to items and 20 services furnished on or after the date of the enact- 21 ment of this Act. 22 (2) EXCEPTION FOR STATE LEGISLATION.—In 23 the case of a State plan under title XIX of the So- 24 cial Security Act (42 U.S.C. 1396 et seq.) that the 25 VerDate Sep 11 2014 02:37 Oct 17, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4742.IS S4742 8 •S 4742 IS Secretary of Health and Human Services determines 1 requires State legislation in order for the respective 2 plan to meet any requirement imposed by amend- 3 ments made by this section, the respective plan shall 4 not be regarded as failing to comply with the re- 5 quirements of such title solely on the basis of its 6 failure to meet such an additional requirement be- 7 fore the first day of the first calendar quarter begin- 8 ning after the close of the first regular session of the 9 State legislature that begins after the date of the en- 10 actment of this Act. For purposes of the previous 11 sentence, in the case of a State that has a 2-year 12 legislative session, each year of the session shall be 13 considered to be a separate regular session of the 14 State legislature. 15 Æ VerDate Sep 11 2014 02:37 Oct 17, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\S4742.IS S4742