Inclusive Clinical Trials Act

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Inclusive Clinical 4 Trials Act’’. 5 VerDate Sep 11 2014 21:58 Jan 07, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H9006.IH H9006 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 9006 IH SEC. 2. PARTICIPATION BY MEDICAID BENEFICIARIES IN 1 APPROVED CLINICAL TRIALS. 2 (a) IN GENERAL.—Title XIX of the Social Security 3 Act (42 U.S.C. 1396 et seq.) is amended by adding at 4 the end the following new section: 5 ‘‘SEC. 1947. PARTICIPATION IN AN APPROVED CLINICAL 6 TRIAL. 7 ‘‘(a) COVERAGE OF ROUTINE PATIENT COSTS ASSO- 8 CIATED WITH APPROVED CLINICAL TRIALS.— 9 ‘‘(1) INCLUSION.—Subject to paragraph (2), 10 routine patient costs shall include all items and serv- 11 ices consistent with the medical assistance provided 12 under the State plan that would otherwise be pro- 13 vided to the individual under such State plan if such 14 individual was not enrolled in an approved clinical 15 trial, including any items or services related to the 16 prevention, detection, and treatment of any medical 17 complications that arise as a result of participation 18 in the approved clinical trial. 19 ‘‘(2) EXCLUSION.—For purposes of paragraph 20 (1), routine patient costs does not include— 21 ‘‘(A) the investigational item, device, or 22 service itself; 23 ‘‘(B) items and services that are provided 24 solely to satisfy data collection and analysis 25 VerDate Sep 11 2014 21:58 Jan 07, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H9006.IH H9006 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 9006 IH needs and that are not used in the direct clin- 1 ical management of the patient; or 2 ‘‘(C) a service that is clearly inconsistent 3 with widely accepted and established standards 4 of care for a particular diagnosis. 5 ‘‘(3) INFORMATION CONCERNING CLINICAL 6 TRIALS.— 7 ‘‘(A) IN GENERAL.—Subject to subpara- 8 graph (B), the Secretary, in consultation with 9 relevant stakeholders, shall develop a single 10 standardized electronic form for use by the indi- 11 vidual or the referring health care provider to 12 submit to the State agency administering the 13 State plan in order to verify that the clinical 14 trial meets the conditions established for an ap- 15 proved clinical trial (as defined in subsection 16 (c)). 17 ‘‘(B) EXCLUDED INFORMATION.—For pur- 18 poses of subparagraph (A) or any such request 19 by the State agency for information regarding 20 a clinical trial, an individual or referring health 21 care provider shall not be required to submit— 22 ‘‘(i) the clinical protocol document for 23 the clinical trial; or 24 VerDate Sep 11 2014 21:58 Jan 07, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H9006.IH H9006 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 9006 IH ‘‘(ii) subject to subparagraph (C), any 1 additional information other than such in- 2 formation as is required pursuant to the 3 form described in subparagraph (A). 4 ‘‘(C) OPTIONAL INFORMATION.—For pur- 5 poses of subparagraphs (A) and (B)(ii), the 6 form may include a requirement that the refer- 7 ring health care provider attest that the indi- 8 vidual is eligible to participate in the clinical 9 trial pursuant to the trial protocol and that in- 10 dividual participation in such trial would be ap- 11 propriate. 12 ‘‘(D) REVIEW OF INFORMATION.— 13 ‘‘(i) IN GENERAL.—A State plan 14 under this title shall establish a process for 15 timely review by the State agency of the 16 form and information submitted pursuant 17 to subparagraph (A) and, not later than 18 48 hours after receipt of such form, con- 19 firmation that the information provided in 20 such form satisfies the requirements estab- 21 lished under such subparagraph, with such 22 process to include establishment and oper- 23 ation of a 24-hour, toll-free telephone num- 24 VerDate Sep 11 2014 21:58 Jan 07, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H9006.IH H9006 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 9006 IH ber and email address to provide for expe- 1 dited communication. 2 ‘‘(ii) FAILURE TO RESPOND.—If an 3 individual or the referring health care pro- 4 vider does not receive a response or re- 5 quest for additional information from the 6 State agency following the 48-hour period 7 described in clause (i), the information 8 provided in the form may be presumed to 9 satisfy the requirements established under 10 this paragraph. 11 ‘‘(b) ENCOURAGEMENT OF PARTICIPATION IN AP- 12 PROVED CLINICAL TRIALS.— 13 ‘‘(1) REASONABLY ACCESSIBLE PROVIDER.— 14 For purposes of participation in an approved clinical 15 trial by an individual eligible for medical assistance 16 under this title, the State agency administering the 17 State plan shall make reasonable efforts to ensure 18 that the individual is provided with access to a pro- 19 vider who is— 20 ‘‘(A) participating in the approved clinical 21 trial; 22 ‘‘(B) located not more than 25 miles from 23 the residence of the individual (or, if no such 24 VerDate Sep 11 2014 21:58 Jan 07, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H9006.IH H9006 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 9006 IH provider is available, as close as possible to the 1 residence of the individual); and 2 ‘‘(C) a participating provider under the 3 State plan or has been deemed to be a partici- 4 pating provider under the State plan for pur- 5 poses of providing medical assistance to the in- 6 dividual during their participation in the ap- 7 proved clinical trial. 8 ‘‘(2) INFORMATIONAL MATERIALS.—The State 9 agency administering the plan approved under this 10 title shall develop informational materials and pro- 11 grams to encourage participating providers to make 12 appropriate referrals to physicians and other appro- 13 priate health care professionals who can provide in- 14 dividuals with access to approved clinical trials. 15 ‘‘(c) DEFINITION OF APPROVED CLINICAL TRIAL.— 16 The term ‘approved clinical trial’ has the same meaning 17 as provided under subsection (d) of section 2709 of the 18 Public Health Service Act that relates to coverage for indi- 19 viduals participating in approved clinical trials.’’. 20 (b) CONFORMING AMENDMENT.—Section 1902(a) of 21 the Social Security Act (42 U.S.C. 1396a(a)) is amend- 22 ed— 23 (1) by striking ‘‘and’’ at the end of paragraph 24 (84); 25 VerDate Sep 11 2014 21:58 Jan 07, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H9006.IH H9006 pbinns on DSKJLVW7X2PROD with BILLS 7 •HR 9006 IH (2) by striking the period at the end of para- 1 graph (85) and inserting ‘‘; and’’; and 2 (3) by inserting after paragraph (85) the fol- 3 lowing new paragraph: 4 ‘‘(86) provide that participation in an approved 5 clinical trial and coverage of routine patient costs 6 associated with such trial for an individual eligible 7 for medical assistance under this title is conducted 8 in accordance with the requirements under section 9 1947.’’. 10 (c) EFFECTIVE DATE.— 11 (1) IN GENERAL.—Except as provided in para- 12 graph (2), the amendments made by this section 13 shall apply to calendar quarters beginning on or 14 after October 1, 2020. 15 (2) DELAY PERMITTED FOR STATE PLAN 16 AMENDMENT.—In the case of a State plan for med- 17 ical assistance under title XIX of the Social Security 18 Act (42 U.S.C. 1396 et seq.) which the Secretary of 19 Health and Human Services determines requires 20 State legislation (other than legislation appro- 21 priating funds) in order for the plan to meet the ad- 22 ditional requirements imposed by the amendments 23 made by this section, the State plan shall not be re- 24 garded as failing to comply with the requirements of 25 VerDate Sep 11 2014 21:58 Jan 07, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H9006.IH H9006 pbinns on DSKJLVW7X2PROD with BILLS 8 •HR 9006 IH such title solely on the basis of its failure to meet 1 these additional requirements before the first day of 2 the first calendar quarter beginning after the close 3 of the first regular session of the State legislature 4 that begins after the date of enactment of this Act. 5 For purposes of the previous sentence, in the case 6 of a State that has a 2-year legislative session, each 7 year of such session shall be deemed to be a sepa- 8 rate regular session of the State legislature. 9 Æ VerDate Sep 11 2014 21:58 Jan 07, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\H9006.IH H9006 pbinns on DSKJLVW7X2PROD with BILLS