,i #aafth ,,congress #b;d ,session ,h4 ,r4 #ijjf ,,in ,,the ,,house ,,of ,,representatives ,december #ag1 #bjbj ,mr4 ,garca of ,illinois introduced the following bill2 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 trials1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,inclusive ,clinical ,trials ,act4 #b4 ,participation by ,medicaid beneficiaries in approved clinical trials 7a7 ,in general ,title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 is amended by adding at the end the following new section3 #aidg4 ,participation in an approved clinical trial 7a7 ,coverage of routine patient costs associated with approved clinical trials 7#a7 ,inclusion ,subject to paragraph 7#b71 routine patient costs shall include all items and services consistent with the medical assistance provided under the ,state plan that would otherwise be provided to the individual under such ,state plan if such individual was not enrolled in an approved clinical trial1 including any items or services related to the prevention1 detection1 and treatment of any medical complications that arise as a result of participation in the approved clinical trial4 7#b7 ,exclusion ,for purposes of paragraph 7#a71 routine patient costs does not include-- 7,a7 the investigational item1 device1 or service itself2 7,b7 items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient2 or 7,c7 a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis4 7#c7 ,information concerning clinical trials 7,a7 ,in general ,subject to subparagraph 7,b71 the ,secretary1 in consultation with relevant stakeholders1 shall develop a single standardized electronic form for use by the individual 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 approved clinical trial 7as defined in subsection 7c774 7,b7 ,excluded information ,for purposes of subparagraph 7,a7 or any such request by the ,state agency for information regarding a clinical trial1 an individual or referring health care provider shall not be required to submit-- 7i7 the clinical protocol document for the clinical trial2 or 7ii7 subject to subparagraph 7,c71 any additional information other than such information as is required pursuant to the form described in subparagraph 7,a74 7,c7 ,optional information ,for purposes of subparagraphs 7,a7 and 7,b77ii71 the form may include a requirement that the referring health care provider attest that the individual is eligible to participate in the clinical trial pursuant to the trial protocol and that individual participation in such trial would be appropriate4 7,d7 ,review of information 7i7 ,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 7,a7 and1 not later than #dh hours after receipt of such form1 confirmation that the information provided in such form satisfies the requirements established under such subparagraph1 with such process to include establishment and operation of a #bd-;hour1 toll-free telephone number and email address to provide for expedited communication4 7ii7 ,failure to respond ,if an individual or the referring health care provider does not receive a response or request for additional information from the ,state agency following the #dh-;hour period described in clause 7i71 the information provided in the form may be presumed to satisfy the requirements established under this paragraph4 7b7 ,encouragement of participation in approved clinical trials 7#a7 ,reasonably accessible provider ,for purposes of participation in an approved clinical trial by an individual eligible for medical assistance under this title1 the ,state agency administering the ,state plan shall make reasonable efforts to ensure that the individual is provided with access to a provider who is-- 7,a7 participating in the approved clinical trial2 7,b7 located not more than #be miles from the residence of the individual 7or1 if no such provider is available1 as close as possible to the residence of the individual72 and 7,c7 a participating provider under the ,state plan or has been deemed to be a participating provider under the ,state plan for purposes of providing medical assistance to the individual during their participation in the approved clinical trial4 7#b7 ,informational materials ,the ,state agency administering the plan approved under this title shall develop informational materials and programs to encourage participating providers to make appropriate referrals to physicians and other appropriate health care professionals who can provide individuals with access to approved clinical trials4 7c7 ,definition of approved clinical trial ,the term approved clinical trial has the same meaning as provided under subsection 7d7 of section #bgji of the ,public ,health ,service ,act that relates to coverage for individuals participating in approved clinical trials4 4 7b7 ,conforming amendment ,section #aijb7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77 is amended-- 7#a7 by striking and at the end of paragraph 7#hd72 7#b7 by striking the period at the end of paragraph 7#he7 and inserting 2 and2 and 7#c7 by inserting after paragraph 7#he7 the following new paragraph3 7#hf7 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 #aidg4 4 7c7 ,effective date 7#a7 ,in general ,except as provided in paragraph 7#b71 the amendments made by this section shall apply to calendar quarters beginning on or after ,october #a1 #bjbj4 7#b7 ,delay permitted for ,state plan amendment ,in the case of a ,state plan for medical assistance under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 which the ,secretary of ,health and ,human ,services determines requires ,state legislation 7other than legislation appropriating funds7 in order for the plan to meet the additional requirements imposed by the amendments made by this section1 the ,state plan shall not be regarded as failing to comply with the requirements of 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 ,act4 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of such session shall be deemed to be a separate regular session of the ,state legislature4