,i #aac? ,,congress #a/ ,session ,h4 ,r4 #bjhe ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #bb1 #bjac ,mr4 ,roskam 7= himself1 ,mr4 ,neal1 ,mr4 ,lance1 ,mr4 ,k9d1 ,mr4 ,gu?rie1 ,mr4 ,pauls51 & ,mr4 ,tib]i7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,ways & ,means1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to create inc5tive = innovative diagno/ics by improv+ ! process = det]m9+ ,m$ic>e paym5t rates = new te/s4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,diagno/ic ,innovation ,te/+ & ,k ,advancem5t ,act ( #bjac4 #b4 ,creat+ inc5tives = innovative diagno/ics 7a7 ,improvem5ts ,to process = det]m9+ fee s*$ule am\nts = new te/s 7#a7 ,cl>ify+ factors = rate-sett+ ,9 det]m9+ ! paym5t am\nt "u gapfill+ proc$ures 7z describ$ 9 section #dad4ejh7;b7 ( title #db1 ,code ( ,f$]al ,regulations1 or any successor regulation to su* section7 = new cl9ical diagno/ic laboratory te/s "u section #ahcc7;h77#h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7h77#h771 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all take into acc\nt1 z applicable & available1 ! foll[+ factors ) respect to su* a new te/3 7,a7 ,impact on pati5t c>e ,! impact ( ! new te/ on pati5t c>e1 pati5t managem5t1 or pati5t treatm5t4 7,b7 ,te*nical *>act]i/ics ,! te*nical *>act]i/ics ( ! new te/1 & ! res\rces requir$ to develop1 validate1 & p]=m ! new te/4 7,c7 ,claims data ,data f claims = :i* paym5t is made "u "p ,b ( title ,,xviii ( ! ,social ,security ,act4 7,d7 ,laboratory *>ges ,am\nts *>g$ by laboratories to self-pay pati5ts = ! new te/4 7,e7 ,private insurance rates ,am\nts paid to laboratories = su* new te/ "u private heal? insurance cov]age (f]$ 9 ! gr\p m>ket & ! individual m>ket4 7,f7 ,advisory panel recomm5dations ,! f9d+s & recomm5dations ( ! indep5d5t advisory panel conv5$ "u p>agraph 7#b7 ) respect to t new te/ & any comm5ts receiv$ dur+ ! op5 meet+ ( ! advisory panel4 7,g7 ,additional factors ,su* o!r factors z ! ,secret>y may specify4 7#b7 ,input f pati5ts1 cl9icians1 & te*nical exp]ts 7,a7 ,requirem5t = indep5d5t advisory panel ,! ,secret>y %all conv5e an indep5d5t advisory panel f :i* ! ,secret>y %all reque/ in=mation & recomm5dations reg>d+ any new te/ 7z ref]r$ to "u subp>agraph 7,a7 ( section #ahcc7;h77#h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7h77#h777 = :i* paym5t is made "u su* section1 includ+ te*nical1 cl9ical1 & quality in=mation4 7,b7 ,composition ( indep5d5t advisory panel ,subject to subp>agraph 7,d71 ! indep5d5t advisory panel %all be compris$ ( #ai memb]s1 includ+-- 7i7 #g individuals ) exp]tise & exp]i5ce ) cl9ical diagno/ic laboratory te/s includ+ exp]tise 9 ! te*nical *>act]i/ics ( ! new te/ z well z exp]tise 9 ! requirem5ts to develop1 validate1 & p]=m ! new te/2 7ii7 #c repres5tatives ( pati5ts1 includ+ a pati5t repres5tative = r>e disord]s2 7iii7 #c cl9icians :o use results ( ! new te/ 9 pati5t c>e2 7iv7 #b laboratorians2 7v7 #b individuals ) exp]tise 9 ! area ( ph>macoeconomics or heal? te*nology assessm5t2 & 7vi7 #b individuals ) exp]tise on ! impact ( new te/s on quality ( pati5t c>e1 includ+ g5etic c\nselors4 7,c7 ,t]ms ,subject to subp>agraph 7,d71 a memb] ( ! panel %all be appo9t$ to s]ve a t]m ( #f ye>s1 except ) respect to ! memb]s fir/ appo9t$1 ^: t]ms ( appo9tm5t %all be /agg]$ ev5ly ov] #b-ye> increm5ts4 7,d7 ,tempor>y appo9tm5t ( exp]ts ,ins(> z ! ,secret>y det]m9es ) respect to a new te/ t !re are an insuffici5t numb] ( memb]s ( ! panel ) exp]tise ) respect to t specific te/1 ! ,secret>y may appo9t individuals :o h exp]tise p]ta9+ to ! new te/ involv$ to s]ve on ! panel4 7,e7 ,op5 meet+s ,! ,secret>y %all receive or review ! f9d+s & recomm5dations ( ! indep5d5t advisory panel ) respect to ! new te/s describ$ 9 subp>agraph 7,a7 involv$ dur+ a meet+ op5 to ! public & provide opportunity = public comm5t4 7,f7 ,cl>ification ( au?ority ( secret>y to consult c>ri]s ,no?+ 9 ?is section %all be con/ru$ z affect+ ! au?ority ( ! ,secret>y to consult ) appropriate ,m$ic>e adm9i/rative contractors4 7#c7 ,ju/ification = paym5t det]m9ations 7,a7 ,initial ju/ification ,) respect to decisions reg>d+ paym5ts made "u ! cl9ical laboratory fee s*$ule = new cl9ical diagno/ic laboratory te/s1 ! ,secret>y %all publicly provide a ju/ification = ! paym5t basis & paym5t rate det]m9ation1 includ+ a detail$ summ>y ( ! in=mation submitt$ to1 or obta9$ by1 ! ,secret>y reg>d+ ! factors specifi$ 9 p>agraph 7#a71 su* t int]e/$ /akehold]s c readily und]/& ! ,secret>y's rationale = ! paym5t basis & rate det]m9ations4 7,b7 ,reconsid]ation p]iod ,aft] provid+ su* ju/ification = a paym5t basis & paym5t rate det]m9ation1 ! ,secret>y %all provide = a reasonable p]iod ( reconsid]ation to receive any appeal ( ! det]m9ation & to evaluate any additional in=mation receiv$ reg>d+ ! ju/ification & ! factors specifi$ 9 p>agraph 7#a74 7,c7 ,f9al det]m9ation ,aft] ! p]iod ( reconsid]ation ! ,secret>y %all make a f9al paym5t basis & paym5t rate det]m9ation & provide a ju/ification = su* f9al det]m9ation expla9+ :at additional in=mation 0 evaluat$ dur+ ! reconsid]ation & h[ su* in=mation 0 tak5 into acc\nt ) respect to ! f9al det]m9ation4 ,no?+ 9 ?is p>agraph %all be con/ru$ z au?oriz+ ! ,secret>y to reveal propriet>y in=mation :i* is o!rwise prohibit$ f disclosure "u law4 7b7 ,process = assignm5t ( tempor>y codes = diagno/ic te/s ,! ,secret>y %all e/abli% a process = application = ! assignm5t ( a tempor>y national ,,hcpcs code to uniquely id5tify a diagno/ic te/ until a p]man5t national ,,hcpcs code is available = assignm5t to t te/4 ,assignm5ts ( a tempor>y national ,,hcpcs code %all occur on a qu>t]ly basis4 ,! ,secret>y %all provide public notice ?r\gh ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,web site ( applications made = su* tempor>y national ,,hcpcs codes4 ,^u assignm5t ( a tempor>y code "u ?is process1 ! ,secret>y %all treat su* te/ z a new te/ = purposes ( section #ahcc7;h77#h7 ( ! ,social ,security ,act4 7c7 ,developm5t ( fur!r improvem5ts 9 rate-,sett+ processes ,! ,secret>y %all analyze ! process us$ = ! gapfill+ proc$ure us$ 9 det]m9+ paym5t am\nts = new cl9ical diagno/ic laboratory te/s "u section #ahcc7;h77#h7 ( ! ,social ,security ,act4 ,tak+ into acc\nt ! *anges made by ?is section1 ! ,secret>y %all id5tify fur!r *anges to improve ! accuracy & appropriat5ess ( result+ rates & ! op5ness1 transp>5cy1 & pr$ictability ( ! process4 ,! ,secret>y %all exam9e :at & h[ _m entities %\ld p]=m gapfill+1 "u contract or o!rwise1 & h[ to ensure t ! process is in=m$ by appropriate exp]tise & proce$s 9 a transp>5t & acc\ntable mann]4 ,! ,secret>y %all implem5t improvem5ts 9 ! process1 ins(> z ^! are possible "u ! law ?r\gh regulations1 aft] public notice & opportunity = comm5t4 ,= *anges ! ,secret>y det]m9es w\ld require a *ange 9 law1 ! ,secret>y %all transmit recomm5dations to ! ,speak] ( ! ,h\se & ! ,presid5t ( ! ,s5ate n lat] ?an ,july #a1 #bjad4 7d7 ,def9itions ,= purposes ( ?is section3 7#a7 ,new cl9ical diagno/ic laboratory te/s ,! t]m new cl9ical diagno/ic laboratory te/ means a cl9ical diagno/ic laboratory te/-- 7,a7 t is assign$ a new or sub/antially revis$ code on or aft] ,janu>y #a1 #bjac2 or 7,b7 = :i* a tempor>y national ,,hcpcs code is grant$ "u subsection 7b7 on or aft] ,janu>y #a1 #bjad4 7#b7 ,self-pay pati5t ,! t]m self-pay pati5t means1 ) respect to a heal? c>e item or s]vice1 an individual :o pays out ( pocket = su* item or s]vice & :o does n h heal? insurance cov]age = su* item or s]vice4 7e7 ,effective date 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ?is section %all take effect on ! date ( enactm5t ( ?is ,act & %all apply ) respect to new cl9ical diagno/ic laboratory te/s4 7#b7 ,application ( ju/ifications to curr5t rate det]m9ations ,subsection 7a77#c7 %all apply to paym5t basis & paym5t rate det]m9ations made on or aft] ,janu>y #a1 #bjac4