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. 

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 ‘‘Inclusive Clinical 

5 Trials Act’’. 


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1 SEC. 2. PARTICIPATION BY MEDICAID BENEFICIARIES IN 

2 APPROVED CLINICAL TRIALS. 

3 (a) IN GENERAL.—Title XIX of the Social Security 

4 Act (42 U.S.C. 1396 et seq.) is amended by adding at 

5 the end the following new section: 

6 ‘‘SEC. 1947. PARTICIPATION IN AN APPROVED CLINICAL 

7 TRIAL. 

8 ‘‘(a) COVERAGE OF ROUTINE PATIENT COSTS ASSO9 CIATED WITH APPROVED CLINICAL TRIALS.— 

10 ‘‘(1) INCLUSION.—Subject to paragraph (2), 

11 routine patient costs shall include all items and serv12 ices consistent with the medical assistance provided 

13 under the State plan that would otherwise be pro14 vided to the individual under such State plan if such 

15 individual was not enrolled in an approved clinical 

16 trial, including any items or services related to the 

17 prevention, detection, and treatment of any medical 

18 complications that arise as a result of participation 

19 in the approved clinical trial. 

20 ‘‘(2) EXCLUSION.—For purposes of paragraph 

21 (1), routine patient costs does not include— 

22 ‘‘(A) the investigational item, device, or 

23 service itself; 

24 ‘‘(B) items and services that are provided 

25 solely to satisfy data collection and analysis 


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1 needs and that are not used in the direct clin2 ical management of the patient; or 

3 ‘‘(C) a service that is clearly inconsistent 

4 with widely accepted and established standards 

5 of care for a particular diagnosis. 

6 ‘‘(3) INFORMATION CONCERNING CLINICAL

7 TRIALS.— 

8 ‘‘(A) IN GENERAL.—Subject to subpara9 graph (B), the Secretary, in consultation with 

10 relevant stakeholders, shall develop a single 

11 standardized electronic form for use by the indi12 vidual or the referring health care provider to 

13 submit to the State agency administering the 

14 State plan in order to verify that the clinical 

15 trial meets the conditions established for an ap16 proved clinical trial (as defined in subsection 

17 (c)). 

18 ‘‘(B) EXCLUDED INFORMATION.—For pur19 poses of subparagraph (A) or any such request 

20 by the State agency for information regarding 

21 a clinical trial, an individual or referring health 

22 care provider shall not be required to submit— 

23 ‘‘(i) the clinical protocol document for 

24 the clinical trial; or 


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1 ‘‘(ii) subject to subparagraph (C), any 

2 additional information other than such in3 formation as is required pursuant to the 

4 form described in subparagraph (A). 

5 ‘‘(C) OPTIONAL INFORMATION.—For pur6 poses of subparagraphs (A) and (B)(ii), the 

7 form may include a requirement that the refer8 ring health care provider attest that the indi9 vidual is eligible to participate in the clinical 

10 trial pursuant to the trial protocol and that in11 dividual participation in such trial would be ap12 propriate. 

13 ‘‘(D) REVIEW OF INFORMATION.— 

14 ‘‘(i) IN GENERAL.—A State plan 

15 under this title shall establish a process for 

16 timely review by the State agency of the 

17 form and information submitted pursuant 

18 to subparagraph (A) and, not later than 

19 48 hours after receipt of such form, con20 firmation that the information provided in 

21 such form satisfies the requirements estab22 lished under such subparagraph, with such 

23 process to include establishment and oper24 ation of a 24-hour, toll-free telephone numVerDate Sep 11 2014 21:58 Jan 07, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H9006.IH H9006

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1 ber and email address to provide for expe2 dited communication. 

3 ‘‘(ii) FAILURE TO RESPOND.—If an 

4 individual or the referring health care pro5 vider does not receive a response or re6 quest for additional information from the 

7 State agency following the 48-hour period 

8 described in clause (i), the information 

9 provided in the form may be presumed to 

10 satisfy the requirements established under 

11 this paragraph. 

12 ‘‘(b) ENCOURAGEMENT OF PARTICIPATION IN AP13 PROVED CLINICAL TRIALS.— 

14 ‘‘(1) REASONABLY ACCESSIBLE PROVIDER.— 

15 For purposes of participation in an approved clinical 

16 trial by an individual eligible for medical assistance 

17 under this title, the State agency administering the 

18 State plan shall make reasonable efforts to ensure 

19 that the individual is provided with access to a pro20 vider who is— 

21 ‘‘(A) participating in the approved clinical 

22 trial; 

23 ‘‘(B) located not more than 25 miles from 

24 the residence of the individual (or, if no such 


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1 provider is available, as close as possible to the 

2 residence of the individual); and 

3 ‘‘(C) a participating provider under the 

4 State plan or has been deemed to be a partici5 pating provider under the State plan for pur6 poses of providing medical assistance to the in7 dividual during their participation in the ap8 proved clinical trial. 

9 ‘‘(2) INFORMATIONAL MATERIALS.—The State 

10 agency administering the plan approved under this 

11 title shall develop informational materials and pro12 grams to encourage participating providers to make 

13 appropriate referrals to physicians and other appro14 priate health care professionals who can provide in15 dividuals with access to approved clinical trials. 

16 ‘‘(c) DEFINITION OF APPROVED CLINICAL TRIAL.— 

17 The term ‘approved clinical trial’ has the same meaning 

18 as provided under subsection (d) of section 2709 of the 

19 Public Health Service Act that relates to coverage for indi20 viduals participating in approved clinical trials.’’. 

21 (b) CONFORMING AMENDMENT.—Section 1902(a) of 

22 the Social Security Act (42 U.S.C. 1396a(a)) is amend23 ed— 

24 (1) by striking ‘‘and’’ at the end of paragraph 

25 (84); 


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1 (2) by striking the period at the end of para2 graph (85) and inserting ‘‘; and’’; and 

3 (3) by inserting after paragraph (85) the fol4 lowing new paragraph: 

5 ‘‘(86) provide that participation in an approved 

6 clinical trial and coverage of routine patient costs 

7 associated with such trial for an individual eligible 

8 for medical assistance under this title is conducted 

9 in accordance with the requirements under section 

10 1947.’’. 

11 (c) EFFECTIVE DATE.— 

12 (1) IN GENERAL.—Except as provided in para13 graph (2), the amendments made by this section 

14 shall apply to calendar quarters beginning on or 

15 after October 1, 2020. 

16 (2) DELAY PERMITTED FOR STATE PLAN

17 AMENDMENT.—In the case of a State plan for med18 ical assistance under title XIX of the Social Security 

19 Act (42 U.S.C. 1396 et seq.) which the Secretary of 

20 Health and Human Services determines requires 

21 State legislation (other than legislation appro22 priating funds) in order for the plan to meet the ad23 ditional requirements imposed by the amendments 

24 made by this section, the State plan shall not be re25 garded as failing to comply with the requirements of 


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1 such title solely on the basis of its failure to meet 

2 these additional requirements before the first day of 

3 the first calendar quarter beginning after the close 

4 of the first regular session of the State legislature 

5 that begins after the date of enactment of this Act. 

6 For purposes of the previous sentence, in the case 

7 of a State that has a 2-year legislative session, each 

8 year of such session shall be deemed to be a sepa9 rate regular session of the State legislature. 

Æ 


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