I 
116TH CONGRESS 
2D SESSION 
H. R. 9006 
To amend title XIX of the Social Security Act to provide for coverage 
under the Medicaid program under such title of routine patient costs 
associated with participation in certain clinical trials, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 17, 2020 
Mr. GARCI´A of Illinois 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 provide 
for coverage under the Medicaid program under such 
title of routine patient costs associated with participation 
in certain 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 ‘‘Inclusive Clinical 
Trials Act’’. 
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SEC. 2. PARTICIPATION BY MEDICAID BENEFICIARIES IN 
APPROVED CLINICAL TRIALS. 
(a) IN GENERAL.—Title XIX of the Social Security 
Act (42 U.S.C. 1396 et seq.) is amended by adding at 
the end the following new section: 
‘‘SEC. 1947. PARTICIPATION IN AN APPROVED CLINICAL 
TRIAL. 
‘‘(a) COVERAGE OF ROUTINE PATIENT COSTS ASSO-
CIATED WITH APPROVED CLINICAL TRIALS.— 
‘‘(1) INCLUSION.—Subject to paragraph (2), 
routine patient costs shall include all items and serv-
ices consistent with the medical assistance provided 
under the State plan that would otherwise be pro-
vided to the individual under such State plan if such 
individual was not enrolled in an approved clinical 
trial, including any items or services related to the 
prevention, detection, and treatment of any medical 
complications that arise as a result of participation 
in the approved clinical trial. 
‘‘(2) EXCLUSION.—For purposes of paragraph 
(1), routine patient costs does not include— 
‘‘(A) the investigational item, device, or 
service itself; 
‘‘(B) items and services that are provided 
solely to satisfy data collection and analysis 
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needs and that are not used in the direct clin-
ical management of the patient; or 
‘‘(C) a service that is clearly inconsistent 
with widely accepted and established standards 
of care for a particular diagnosis. 
‘‘(3) 
INFORMATION
CONCERNING
CLINICAL 
TRIALS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the Secretary, in consultation with 
relevant stakeholders, shall develop a single 
standardized electronic form for use by the indi-
vidual or the referring health care provider to 
submit to the State agency administering the 
State plan in order to verify that the clinical 
trial meets the conditions established for an ap-
proved clinical trial (as defined in subsection 
(c)). 
‘‘(B) EXCLUDED INFORMATION.—For pur-
poses of subparagraph (A) or any such request 
by the State agency for information regarding 
a clinical trial, an individual or referring health 
care provider shall not be required to submit— 
‘‘(i) the clinical protocol document for 
the clinical trial; or 
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‘‘(ii) subject to subparagraph (C), any 
additional information other than such in-
formation as is required pursuant to the 
form described in subparagraph (A). 
‘‘(C) OPTIONAL INFORMATION.—For pur-
poses of subparagraphs (A) and (B)(ii), the 
form may include a requirement that the refer-
ring health care provider attest that the indi-
vidual is eligible to participate in the clinical 
trial pursuant to the trial protocol and that in-
dividual participation in such trial would be ap-
propriate. 
‘‘(D) REVIEW OF INFORMATION.— 
‘‘(i) IN
GENERAL.—A State plan 
under this title shall establish a process for 
timely review by the State agency of the 
form and information submitted pursuant 
to subparagraph (A) and, not later than 
48 hours after receipt of such form, con-
firmation that the information provided in 
such form satisfies the requirements estab-
lished under such subparagraph, with such 
process to include establishment and oper-
ation of a 24-hour, toll-free telephone num-
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ber and email address to provide for expe-
dited communication. 
‘‘(ii) FAILURE
TO
RESPOND.—If an 
individual or the referring health care pro-
vider does not receive a response or re-
quest for additional information from the 
State agency following the 48-hour period 
described in clause (i), the information 
provided in the form may be presumed to 
satisfy the requirements established under 
this paragraph. 
‘‘(b) ENCOURAGEMENT OF PARTICIPATION IN AP-
PROVED CLINICAL TRIALS.— 
‘‘(1) REASONABLY
ACCESSIBLE
PROVIDER.— 
For purposes of participation in an approved clinical 
trial by an individual eligible for medical assistance 
under this title, the State agency administering the 
State plan shall make reasonable efforts to ensure 
that the individual is provided with access to a pro-
vider who is— 
‘‘(A) participating in the approved clinical 
trial; 
‘‘(B) located not more than 25 miles from 
the residence of the individual (or, if no such 
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provider is available, as close as possible to the 
residence of the individual); and 
‘‘(C) a participating provider under the 
State plan or has been deemed to be a partici-
pating provider under the State plan for pur-
poses of providing medical assistance to the in-
dividual during their participation in the ap-
proved clinical trial. 
‘‘(2) INFORMATIONAL MATERIALS.—The State 
agency administering the plan approved under this 
title shall develop informational materials and pro-
grams to encourage participating providers to make 
appropriate referrals to physicians and other appro-
priate health care professionals who can provide in-
dividuals with access to approved clinical trials. 
‘‘(c) DEFINITION OF APPROVED CLINICAL TRIAL.— 
The term ‘approved clinical trial’ has the same meaning 
as provided under subsection (d) of section 2709 of the 
Public Health Service Act that relates to coverage for indi-
viduals participating in approved clinical trials.’’. 
(b) CONFORMING AMENDMENT.—Section 1902(a) of 
the Social Security Act (42 U.S.C. 1396a(a)) is amend-
ed— 
(1) by striking ‘‘and’’ at the end of paragraph 
(84); 
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(2) by striking the period at the end of para-
graph (85) and inserting ‘‘; and’’; and 
(3) by inserting after paragraph (85) the fol-
lowing new paragraph: 
‘‘(86) provide that participation in an approved 
clinical trial and coverage of routine patient costs 
associated with such trial for an individual eligible 
for medical assistance under this title is conducted 
in accordance with the requirements under section 
1947.’’. 
(c) EFFECTIVE DATE.— 
(1) IN GENERAL.—Except as provided in para-
graph (2), the amendments made by this section 
shall apply to calendar quarters beginning on or 
after October 1, 2020. 
(2) DELAY
PERMITTED
FOR
STATE
PLAN 
AMENDMENT.—In the case of a State plan for med-
ical assistance under title XIX of the Social Security 
Act (42 U.S.C. 1396 et seq.) which the Secretary of 
Health and Human Services determines requires 
State legislation (other than legislation appro-
priating funds) in order for the plan to meet the ad-
ditional requirements imposed by the amendments 
made by this section, the State plan shall not be re-
garded as failing to comply with the requirements of 
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such title solely on the basis of its failure to meet 
these additional requirements before the first day of 
the first calendar quarter beginning after the close 
of the first regular session of the State legislature 
that begins after the date of enactment 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 such session shall be deemed to be a sepa-
rate regular session of the State legislature. 
Æ 
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