I 

116TH CONGRESS 

1ST SESSION H. R. 913 

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 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. 

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 

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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 (ff), 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 ‘‘(ff)(1) ROUTINE PATIENT COSTS.—For purposes of 

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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 provided to 

16 the individual solely to satisfy data collection 

17 and analysis needs for the qualifying clinical 

18 trial and is not used in the direct clinical man19 agement of the individual. 

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

21 ‘‘(A) IN GENERAL.—For purposes of this sub22 section and subsection (a)(30), the term ‘qualifying 

23 clinical trial’ means a phase I, phase II, phase III, 

24 or phase IV clinical trial that is conducted in rela25 tion to the prevention, detection, or treatment of 


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1 cancer or any other life-threatening condition and is 

2 described in any of the following clauses: 

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

4 or funded (which may include funding through 

5 in-kind contributions) by one or more of the fol6 lowing: 

7 ‘‘(I) The National Institutes of 

8 Health. 

9 ‘‘(II) The Centers for Disease Control 

10 and Prevention. 

11 ‘‘(III) The Agency for Healthcare Re12 search and Quality. 

13 ‘‘(IV) The Centers for Medicare & 

14 Medicaid Services. 

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

16 any of the entities described in subclauses 

17 (I) through (IV) or the Department of De18 fense or the Department of Veterans Af19 fairs. 

20 ‘‘(VI) A qualified non-governmental 

21 research entity identified in the guidelines 

22 issued by the National Institutes of Health 

23 for center support grants. 


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1 ‘‘(VII) Any of the following if the con2 ditions described in subparagraph (B) are 

3 met: 

4 ‘‘(aa) The Department of Vet5 erans Affairs. 

6 ‘‘(bb) The Department of De7 fense. 

8 ‘‘(cc) The Department of Energy. 

9 ‘‘(ii) The clinical trial is conducted under 

10 an investigational new drug application re11 viewed by the Food and Drug Administration. 

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

13 is exempt from having such an investigational 

14 new drug application. 

15 ‘‘(B) CONDITIONS.—For purposes of subpara16 graph (A)(i)(VII), the conditions described in this 

17 subparagraph, with respect to a clinical trial ap18 proved or funded by an entity described in such sub19 paragraph (A)(i)(VII), are that the clinical trial has 

20 been reviewed and approved through a system of 

21 peer review that the Secretary determines— 

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

23 review of studies and investigations used by the 

24 National Institutes of Health; and 


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

2 scientific standards by qualified individuals with 

3 no interest in the outcome of the review. 

4 ‘‘(3) LIFE-THREATENING CONDITION DEFINED.— 

5 For purposes of this subsection, the term ‘life-threatening 

6 condition’ means any disease or condition from which the 

7 likelihood of death is probable unless the course of the dis8 ease or condition is interrupted. 

9 ‘‘(4) 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 48 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 solely on attestation regard20 ing the appropriateness of the qualifying clinical 

21 trial by the health care provider and principal inves22 tigator described in subparagraph (B), which shall 

23 be made using a streamlined, uniform form devel24 oped for national use by the Secretary and that in25 cludes the option to reference information regarding 


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1 the qualifying clinical trial that is publicly available 

2 on a 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) ENSURING ACCESS FOR MEDICAID EXPANSION

13 POPULATION.—Section 1937(b)(5) of such Act is amend14 ed by inserting before the period at the end the following: 

15 ‘‘, and beginning January 1, 2020, coverage of routine pa16 tient costs for items and services furnished in connection 

17 with participation in a qualifying clinical trial (as defined 

18 in section 1905(ff))’’. 

19 (d) EFFECTIVE DATE.— 

20 (1) IN GENERAL.—The amendments made by 

21 this section shall apply with respect to items and 

22 services furnished on or after the date of the enact23 ment of this Act. 

24 (2) EXCEPTION FOR STATE LEGISLATION.—In 

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1 cial Security Act (42 U.S.C. 1396 et seq.) that the 

2 Secretary of Health and Human Services determines 

3 requires State legislation in order for the respective 

4 plan to meet any requirement imposed by amend5 ments made by this section, the respective plan shall 

6 not be regarded as failing to comply with the re7 quirements of such title solely on the basis of its 

8 failure to meet such an additional requirement be9 fore the first day of the first calendar quarter begin10 ning after the close of the first regular session of the 

11 State legislature that begins after the date of the en12 actment of this Act. For purposes of the previous 

13 sentence, in the case of a State that has a 2-year 

14 legislative session, each year of the session shall be 

15 considered to be a separate regular session of the 

16 State legislature. 

Æ 


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