II 

116TH CONGRESS 

2D SESSION S. 4742 

To amend title XIX of the Social Security Act to promote access to lifesaving 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. 

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. 

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 ‘‘Covering Life-saving 

5 Investigations Needed In Cancer And other Life-threat6 ening conditions through Timely use of Resources for 

7 Easy and Affordable Treatment from Medicaid for EnrollVerDate Sep 11 2014 18:30 Oct 20, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4742.IS S4742
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1 ees in Need Today Act’’ or the ‘‘CLINICAL TREAT2 MENT Act’’. 

3 SEC. 2. PROMOTING ACCESS TO LIFE-SAVING THERAPIES 

4 FOR MEDICAID ENROLLEES BY ENSURING 

5 COVERAGE OF ROUTINE PATIENT COSTS FOR 

6 ITEMS AND SERVICES FURNISHED IN CON7 NECTION WITH PARTICIPATION IN QUALI8 FYING CLINICAL TRIALS. 

9 (a) IN GENERAL.—Section 1905 of the Social Secu10 rity Act (42 U.S.C. 1396d) is amended— 

11 (1) in subsection (a)— 

12 (A) in paragraph (29), by striking ‘‘and’’ 

13 at the end; 

14 (B) by redesignating paragraph (30) as 

15 paragraph (31); and 

16 (C) by inserting after paragraph (29) the 

17 following new paragraph: 

18 ‘‘(30) subject to subsection (gg), routine patient 

19 costs for items and services furnished in connection 

20 with participation in a qualifying clinical trial (as 

21 defined in such subsection); and’’; and 

22 (2) by adding at the end the following new sub23 section: 

24 ‘‘(gg)(1) ROUTINE PATIENT COSTS.—For purposes 

25 of subsection (a)(30), with respect to a State and an indiVerDate Sep 11 2014 02:37 Oct 17, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4742.IS S4742
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1 vidual enrolled under the State plan (or a waiver of such 

2 plan) who participates in a qualifying clinical trial, routine 

3 patient costs— 

4 ‘‘(A) include any item or service provided to the 

5 individual under the qualifying clinical trial, includ6 ing any item or service provided to prevent, diag7 nose, or treat complications resulting from such par8 ticipation, to the extent that the provision of such an 

9 item or service to the individual outside the course 

10 of such participation would otherwise be covered 

11 under the State plan or waiver; and 

12 ‘‘(B) does not include— 

13 ‘‘(i) the investigational item or service that 

14 is the subject of the qualifying clinical trial; or 

15 ‘‘(ii) an item or service that is— 

16 ‘‘(I) provided to the individual solely 

17 to satisfy data collection and analysis 

18 needs for the qualifying clinical trial and is 

19 not used in the direct clinical management 

20 of the individual; and 

21 ‘‘(II) not otherwise covered under the 

22 State plan or waiver. 

23 ‘‘(2) QUALIFYING CLINICAL TRIAL DEFINED.— 

24 ‘‘(A) IN GENERAL.—For purposes of this sub25 section and subsection (a)(30), the term ‘qualifying 

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1 clinical trial’ means a clinical trial (in any clinical 

2 phase of development) that is conducted in relation 

3 to the prevention, detection, or treatment of any se4 rious or life-threatening disease or condition and is 

5 described in any of the following clauses: 

6 ‘‘(i) The study or investigation is approved 

7 or funded (which may include funding through 

8 in-kind contributions) by one or more of the fol9 lowing: 

10 ‘‘(I) The National Institutes of 

11 Health. 

12 ‘‘(II) The Centers for Disease Control 

13 and Prevention. 

14 ‘‘(III) The Agency for Healthcare Re15 search and Quality. 

16 ‘‘(IV) The Centers for Medicare & 

17 Medicaid Services. 

18 ‘‘(V) A cooperative group or center of 

19 any of the entities described in subclauses 

20 (I) through (IV) or the Department of De21 fense or the Department of Veterans Af22 fairs. 

23 ‘‘(VI) A qualified non-governmental 

24 research entity identified in the guidelines 

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1 issued by the National Institutes of Health 

2 for center support grants. 

3 ‘‘(VII) Any of the following if the con4 ditions described in subparagraph (B) are 

5 met: 

6 ‘‘(aa) The Department of Vet7 erans Affairs. 

8 ‘‘(bb) The Department of De9 fense. 

10 ‘‘(cc) The Department of Energy. 

11 ‘‘(ii) The clinical trial is conducted pursu12 ant to an investigational new drug exemption 

13 under section 505(i) of the Federal Food, Drug, 

14 and Cosmetic Act (21 U.S.C. 355(i)) or an ex15 emption for a biological product undergoing in16 vestigation under section 351(a)(3) of the Pub17 lic Health Service Act (42 U.S.C. 262(a)(3)). 

18 ‘‘(iii) The clinical trial is a drug trial that 

19 is exempt from having such an investigational 

20 new drug application. 

21 ‘‘(B) CONDITIONS.—For purposes of subpara22 graph (A)(i)(VII), the conditions described in this 

23 subparagraph, with respect to a clinical trial ap24 proved or funded by an entity described in such sub25 paragraph (A)(i)(VII), are that the clinical trial has 

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1 been reviewed and approved through a system of 

2 peer review that the Secretary determines— 

3 ‘‘(i) to be comparable to the system of peer 

4 review of studies and investigations used by the 

5 National Institutes of Health; and 

6 ‘‘(ii) assures unbiased review of the highest 

7 scientific standards by qualified individuals with 

8 no interest in the outcome of the review. 

9 ‘‘(3) COVERAGE DETERMINATION REQUIREMENTS.— 

10 A determination with respect to coverage under subsection 

11 (a)(30) for an individual participating in a qualifying clin12 ical trial— 

13 ‘‘(A) shall be expedited and completed within 

14 24 hours; 

15 ‘‘(B) shall be made without limitation on the 

16 geographic location or network affiliation of the 

17 health care provider treating such individual or the 

18 principal investigator of the qualifying clinical trial; 

19 ‘‘(C) shall be based on attestation regarding the 

20 appropriateness of the qualifying clinical trial by the 

21 health care provider and principal investigator de22 scribed in subparagraph (B), which shall be made 

23 using a streamlined, uniform form developed for na24 tional use by the Secretary and that includes the op25 tion to reference information regarding the qualiVerDate Sep 11 2014 02:37 Oct 17, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4742.IS S4742
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1 fying clinical trial that is publicly available on a 

2 website maintained by the Secretary, such as 

3 clinicaltrials.gov (or a successor website); and 

4 ‘‘(D) shall not require submission of the proto5 cols of the qualifying clinical trial, or any other doc6 umentation that may be proprietary or determined 

7 by the Secretary to be burdensome to provide.’’. 

8 (b) REQUIRING MANDATORY COVERAGE UNDER

9 STATE PLAN.—Section 1902(a)(10)(A) of such Act is 

10 amended, in the matter preceding clause (i), by striking 

11 ‘‘and (29)’’ and inserting ‘‘(29), and (30)’’. 

12 (c) INCLUSION IN BENCHMARK COVERAGE.—Section 

13 1937(b)(5) of such Act is amended by inserting before the 

14 period at the end the following: ‘‘, and beginning January 

15 1, 2020, coverage of routine patient costs for items and 

16 services furnished in connection with participation in a 

17 qualifying clinical trial (as defined in section 1905(gg))’’. 

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 enact22 ment of this Act. 

23 (2) EXCEPTION FOR STATE LEGISLATION.—In 

24 the case of a State plan under title XIX of the So25 cial Security Act (42 U.S.C. 1396 et seq.) that the 

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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 amend4 ments made by this section, the respective plan shall 

5 not be regarded as failing to comply with the re6 quirements of such title solely on the basis of its 

7 failure to meet such an additional requirement be8 fore the first day of the first calendar quarter begin9 ning after the close of the first regular session of the 

10 State legislature that begins after the date of the en11 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. 

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