,i #aagth ,,congress #b;d ,session ,h4 ,r4 #hedf ,,in ,,the ,,house ,,of ,,representatives ,july #bg1 #bjbb,ms4 ,speier 7for herself and ,mr4 ,mc,caul7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to amend title ,,xxvii of the ,public ,health ,service ,act to require out-of-network coverage for qualified individuals participating in approved clinical trials1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,clinical ,trial ,coverage ,act of #bjbb4 #b4 ,amendments relating to coverage in individual and group market and under ,medicare program for qualified individuals participating in approved clinical trials 7a7 ,individual and group market 7#a7 ,requiring out-of-network coverage of routine patient costs ,section #bgji of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#h7 is amended-- 7,a7 in subsection 7a77#a7-- 7i7 in subparagraph 7,b7-- 7,i7 by striking subject to subsection 7c712 and 7,,ii7 by striking and at the end2 7ii7 by redesignating subparagraph 7,c7 as subparagraph 7,d72 and 7iii7 by inserting after subparagraph 7,b7 the following new subparagraph3 7,c7 in the case of routine patient costs for items or services furnished to the individual in connection with participation in the trial by a nonparticipating provider-- 7i7 shall impose the same cost-sharing requirement 7expressed as a copayment amount or coinsurance rate7 that would apply if such item or service was furnished by a participating provider2 and 7ii7 shall pay to such nonparticipating provider the amount by which the recognized amount for such item or service exceeds the cost-sharing amount for such item or service 7as determined in accordance with clause 7i772 and 2 7,b7 by striking subsection 7c72 7,c7 by redesignating subsections 7d7 through 7h7 as subsections 7c7 through 7g71 respectively2 and 7,d7 by adding at the end the following new subsection3 7h7 ,other definitions ,for purposes of this section1 the terms nonparticipating provider1 participating provider1 and recognized amount have the meaning given such terms in section #bgii;,a-#a7;a77#c74 4 7#b7 ,amendment relating to definition of routine patient costs ,section #bgji7;a77#b77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#h7;a77#b77;,a77 is amended-- 7,a7 by striking include all items and services and inserting include-- 7i7 all items and services 2 and 7,b7 by striking the period at the end and inserting 2 and 7ii7 consultation and referral services relating to approved clinical trials furnished to qualified individuals4 4 7#c7 ,amendment relating to definition of approved clinical trial ,section #bgji7;c77#a77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#h7;c77#a77;,a771 as redesignated by paragraph 7#a71 is amended by adding at the end the following new clause3 7viii7 ,the ,patient-,centered ,outcomes ,research ,institute4 4 7#d7 ,technical and conforming amendments ,section #bgji of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#h71 as amended by the preceding paragraphs1 is further amended-- 7,a7 in subsection 7a7-- 7i7 in paragraph 7#a77;,a71 by inserting before clinical trial referred to in subsection 7b77#b7 the following3 approved2 7ii7 in paragraph 7#b77;,a71 by striking a clinical trial and inserting an approved clinical trial2 7iii7 in paragraph 7#c7-- 7,i7 by striking in-network providers and inserting participating providers2 and 7,,ii7 by striking a clinical trial and inserting an approved clinical trial2 and 7iv7 in paragraph 7#d71 by striking out-of-network and inserting nonparticipating providers2 7,b7 in subsection 7b77#b77;,a71 by striking participating health care provider and inserting participating provider2 and 7,c7 in subsection 7d77#a77;,a77v71 by striking cooperative group and inserting ,a cooperative group4 7#e7 ,effective date ,the amendments made by this subsection shall apply with respect to plan years beginning on or after ,january #a1 #bjbd4 7b7 ,medicare 7#a7 ,amendment relating to definition of routine costs of care ,section #ahfb7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7m77 is amended-- 7,a7 in paragraph 7#a71 by inserting before as defined by the ,secretary the following3 subject to paragraph 7#c712 and 7,b7 by adding at the end the following new paragraph3 7#c7 ,routine costs of care ,in defining routine costs of care for purposes of paragraph 7#a71 the ,secretary shall define such term in a manner that provides for coverage of consultation and referral services furnished to an individual in the course of participation in a category ,a clinical trial4 4 7#b7 ,amendment relating to definition of category ,a clinical trial ,section #ahfb7m77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7m77#b77 is amended by inserting after means a trial the following3 7including a trial funded by the ,patient-,centered ,outcomes ,research ,institute74 7#c7 ,effective date ,the amendments made by this subsection shall apply with respect to items and services furnished on or after ,january #a1 #bjbd4 #c4 ,voluntary network of participating providers 7a7 ,in general ,the ,secretary of ,health and ,human ,services may issue a request for information from group health plans1 and health insurance issuers offering group or individual health coverage to identify an interest in establishing a voluntary network of participating providers administered by a third-party administrator 7as designated by the ,secretary7 for purposes of complying with coverage requirements for clinical trials under section #bgji of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#h74 7b7 ,definitions ,in this section3 7#a7 ,group health plan ,the term group health plan has the meaning given such term in section #fjg7a7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aafg7a774 7#b7 ,health insurance issuer ,the term health insurance issuer has the meaning given such term in section #bgia7;b77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia7;b77#a774 7#c7 ,participating provider ,the term participating provider has the meaning given such term in section #bgii;,a-#a7;a77#c77;,g77ii7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa7;a77#c77;,g77ii774