,i #aafth ,,congress #ast ,session ,h4 ,r4 #iac ,,in ,,the ,,house ,,of ,,representatives ,january #cj1 #bjai,mr4 ,lujn 7for himself and ,mr4 ,bilirakis7 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 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 trials1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,covering ,life-saving ,investigations ,needed in ,cancer and ,other ,life-threatening ,conditions through ,timely use of ,resources for ,easy and ,affordable ,treatment from ,medicaid for ,enrollees in ,need ,today ,act or the ,,clinical ,,treatment ,act4 #b4 ,promoting 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 7a7 ,in general ,section #aije of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#bi71 by striking and at the end2 7,b7 by redesignating paragraph 7#cj7 as paragraph 7#ca72 and 7,c7 by inserting after paragraph 7#bi7 the following new paragraph3 7#cj7 subject to subsection 7ff71 routine patient costs for items and services furnished in connection with participation in a qualifying clinical trial 7as defined in such subsection72 and 2 and 7#b7 by adding at the end the following new subsection3 7ff7 7#a7 ,routine patient costs ,for purposes of subsection 7a77#cj71 with respect to a ,state and an individual enrolled under the ,state plan 7or a waiver of such plan7 who participates in a qualifying clinical trial1 routine patient costs-- 7,a7 include any item or service provided to the individual under the qualifying clinical trial1 including any item or service provided to prevent1 diagnose1 or treat complications resulting from such participation1 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 7or waiver72 and 7,b7 does not include-- 7i7 the investigational item or service that is the subject of the qualifying clinical trial2 or 7ii7 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 management of the individual4 7#b7 ,qualifying clinical trial defined 7,a7 ,in general ,for purposes of this subsection and subsection 7a77#cj71 the term qualifying clinical trial means a phase ,i1 phase ,,ii1 phase ,,iii1 or phase ,,iv clinical trial that is conducted in relation to the prevention1 detection1 or treatment of cancer or any other life-threatening condition and is described in any of the following clauses3 7i7 ,the study or investigation is approved or funded 7which may include funding through in-kind contributions7 by one or more of the following3 7,i7 ,the ,national ,institutes of ,health4 7,,ii7 ,the ,centers for ,disease ,control and ,prevention4 7,,iii7 ,the ,agency for ,healthcare ,research and ,quality4 7,,iv7 ,the ,centers for ,medicare ,medicaid ,services4 7,v7 ,a cooperative group or center of any of the entities described in subclauses 7,i7 through 7,,iv7 or the ,department of ,defense or the ,department of ,veterans ,affairs4 7,,vi7 ,a qualified non-governmental research entity identified in the guidelines issued by the ,national ,institutes of ,health for center support grants4 7,,vii7 ,any of the following if the conditions described in subparagraph 7,b7 are met3 7aa7 ,the ,department of ,veterans ,affairs4 7bb7 ,the ,department of ,defense4 7cc7 ,the ,department of ,energy4 7ii7 ,the clinical trial is conducted under an investigational new drug application reviewed by the ,food and ,drug ,administration4 7iii7 ,the clinical trial is a drug trial that is exempt from having such an investigational new drug application4 7,b7 ,conditions ,for purposes of subparagraph 7,a77i77,,vii71 the conditions described in this subparagraph1 with respect to a clinical trial approved or funded by an entity described in such subparagraph 7,a77i77,,vii71 are that the clinical trial has been reviewed and approved through a system of peer review that the ,secretary determines-- 7i7 to be comparable to the system of peer review of studies and investigations used by the ,national ,institutes of ,health2 and 7ii7 assures unbiased review of the highest scientific standards by qualified individuals with no interest in the outcome of the review4 7#c7 ,life-threatening condition defined ,for purposes of this subsection1 the term life-threatening condition means any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted4 7#d7 ,coverage determination requirements ,a determination with respect to coverage under subsection 7a77#cj7 for an individual participating in a qualifying clinical trial-- 7,a7 shall be expedited and completed within #dh hours2 7,b7 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 trial2 7,c7 shall be based solely on attestation regarding the appropriateness of the qualifying clinical trial by the health care provider and principal investigator described in subparagraph 7,b71 which shall be made using a streamlined1 uniform form developed for national use by the ,secretary and that includes the option to reference information regarding the qualifying clinical trial that is publicly available on a website maintained by the ,secretary1 such as clinicaltrials4gov 7or a successor website72 and 7,d7 shall not require submission of the protocols of the qualifying clinical trial1 or any other documentation that may be proprietary or determined by the ,secretary to be burdensome to provide4 4 7b7 ,requiring mandatory coverage under ,state plan ,section #aijb7;a77#aj77;,a7 of such ,act is amended1 in the matter preceding clause 7i71 by striking and 7#bi7 and inserting 7#bi71 and 7#cj74 7c7 ,ensuring access for ,medicaid expansion population ,section #aicg7;b77#e7 of such ,act is amended by inserting before the period at the end the following3 1 and beginning ,january #a1 #bjbj1 coverage of routine patient costs for items and services furnished in connection with participation in a qualifying clinical trial 7as defined in section #aije7;ff774 7d7 ,effective date 7#a7 ,in general ,the amendments made by this section shall apply with respect to items and services furnished on or after the date of the enactment of this ,act4 7#b7 ,exception for ,state legislation ,in the case of a ,state plan under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 that the ,secretary of ,health and ,human ,services determines requires ,state legislation in order for the respective plan to meet any requirement imposed by amendments made by this section1 the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement 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 the 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 the session shall be considered to be a separate regular session of the ,state legislature4