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