,i #aai? ,,congress #a/ ,session ,h4 ,r4 #fheb ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #ah1 #bjbe,mr4 ,evans ( ,colorado 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 am5d title ,,xviii ( ! ,social ,security ,act to adju/ paym5t = sk9 sub/itute products "u ! ,m$ic>e program4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,advanc$ ,w\nd ,c>e & ,reg5]ative ,m$ic9e ,access & ,re=m ,act4 #b4 ,paym5t re=m = sk9 sub/itute products 7a7 ,cov]age ( sk9 sub/itute products ,section #ahfa7s77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is am5d$-- 7#a7 9 subp>agraph 7,,ii71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,,jj71 by add+ & at ! end2 & 7#c7 by ins]t+ aft] subp>agraph 7,,jj7 ! foll[+ new subp>agraph3 7,,kk7 sk9 sub/itute products 7z def9$ 9 section #ahdg;,a7c77#f77;,j774 4 7b7 ,paym5t 7#a7 ,paym5t am\nt ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is am5d$-- 7,a7 9 subsection 7a77#a7-- 7i7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 7ii7 by /rik+ %all apply to & ins]t+ 8%all apply-- 7,a7 to 2 & 7iii7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 to paym5t = sk9 sub/itute products 7z def9$ 9 subsection 7c77#f77;,j77 t are furni%$ on or aft] ,janu>y #a1 #bjbf4 2 & 7,b7 9 subsection 7b7-- 7i7 9 p>agraph 7#a7-- 7,i7 9 ! text prec$+ subp>agraph 7,a71 by ins]t+ or a sk9 sub/itute product aft] drug or biological2 7,,ii7 9 subp>agraph 7,b71 by /rik+ or at ! end2 7,,iii7 9 subp>agraph 7,c71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,,iv7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 9 ! case ( a sk9 sub/itute product 7z def9$ 9 subsection 7c77#f77;,j771 ! am\nt det]m9$ "u p>agraph 7#i74 2 & 7ii7 9 p>agraph 7#b7-- 7,i7 9 subp>agraph 7,a71 by ins]t+ or a sk9 sub/itute product aft] drug or biological2 & 7,,ii7 9 subp>agraph 7,b71 by ins]t+ 1 &1 ) respect to a sk9 sub/itute product1 a squ>e c5timet] aft] p]ta9+ to liquids2 & 7iii7 by add+ at ! end ! foll[+3 7#i7 ,sk9 sub/itute products 7,a7 ,paym5t am\nt 7i7 ,initial paym5t am\nt ,= #bjbf1 ! am\nt det]m9$ "u ?is p>agraph = a sk9 sub/itute product is ! volume-weight$ av]age ( ! ,m$ic>e paym5t all[ance limits = sk9 sub/itute products1 z det]m9$ "u subp>agraph 7,b74 7ii7 ,annual update ,= #bjbg & ea* subsequ5t ye>1 ! am\nt det]m9$ "u ?is p>agraph = a sk9 sub/itute product = su* ye> is equal to ! am\nt det]m9$ "u ?is p>agraph = ! previ\s ye>1 adju/$ by ! p]c5tage increase 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( su* previ\s ye>4 7,b7 ,volume-weight$ av]age paym5t limit ,= purposes ( subp>agraph 7,a77i71 ! volume-weight$ av]age ( ! ,m$ic>e paym5t all[ance limits = sk9 sub/itute products is det]m9$ by-- 7i7 calculat+1 ) respect to ea* bill+ & paym5t code li/$ 9 ! ,april #bjbc ,,asp ,pric+ ,file = ea* sk9 sub/itute product1 an am\nt equal to ! product (-- 7,i7 ! paym5t limit includ$ 9 su* file ) respect to su* code2 & 7,,ii7 ! numb] ( units 7z specifi$ "u p>agraph 7#b77-- 7aa7 bill$ ) respect to su* code = a date ( s]vice 9 #bjbc2 & 7bb7 li/$ 9 ! ,,cms ,integrat$ ,data ,repository = ,"p ,b 7,c>ri] ,,dme7 claims data2 7ii7 calculat+ ! sum ( all am\nts det]m9$ "u clause 7i72 & 7iii7 divid+ ! sum calculat$ "u clause 7ii7 by ! total numb] ( units det]m9$ "u clause 7i77,,ii74 4 7#b7 ,con=m+ am5dm5ts ,section #ahcc7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is am5d$-- 7,a7 9 subp>agraph 7,s77i71 by /rik+ subject to subp>agraph 7,,ee7'' & ins]t+ #8#8subject to subp>agraphs 7,,ee7 & 7,,ii7' 2 7,b7 by /rik+ & 7,,hh7 & ins]t+ 7,,hh72 & 7,c7 by ins]t+ 1 & 7,,ii7 ) respect to sk9 sub/itute products "u section #ahfa7s77#b77,,kk71 ! am\nt paid %all be #hj p]c5t ( ! less] ( ! actual *>ge or ! paym5t am\nt e/abli%$ "u section #ahdg;,a7b77#i7 be=e ! semicolon at ! end4 7c7 ,sk9 sub/itute product def9$ ,section #ahdg;,a7c77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77 is am5d$ by add+ at ! end ! foll[+3 7,j7 ,sk9 sub/itute products ,! t]m sk9 sub/itute product-- 7i7 means a cellul>1 tissue1 biological or syn!tic mat]ial t-- 7,i7 is appli$ to a w\nd & int5d$ to rema9 )9 ! w\nd b$2 & 7,,ii7 is m>ket$ pursuant to section #eaj7k71 #eac7;f77#b71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 or section #cfa ( ! ,public ,heal? ,s]vice ,act2 & 7ii7 does n include a product t is int5d$ to tempor>ily protect or cov] ! w\nd b$ & be remov$ )\t resorption su* z a dress+2 & 7iii7 ! t]m sk9 sub/itute product %all include any products reimburs$ pursuant to sk9 sub/itutes codes by ! ,m$ic>e program at any "t prior to ,janu>y #a1 #bjbf4 4 7d7 ,exclusion f report+ requirem5ts ,section #ahdg;,a7f77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7f77#b77;,a77 is am5d$ by ins]t+ 7except t1 beg9n+ ,janu>y #a1 #bjbf1 a drug or biological s describ$ does n include a sk9 sub/itute product 7z def9$ 9 subsection 7c77#f77;,j777 aft] products t are payable "u ?is "p z a drug or biological4 7e7 ,consolidat$ bill+ & paym5t code ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y ( ,heal? & ,human ,s]vices %all e/abli% a new bill+ & paym5t code = all sk9 sub/itute products 7z def9$ 9 subp>agraph 7,j7 ( section #ahdg;,a7c77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f771 z add$ by subsection 7b774 #c4 ,equival5t reimbursem5t 9 outpati5t sites ( c>e ,! ,secret>y %all ensure t reimbursem5t = sk9 sub/itutes products & outpati5t applications ( sk9 sub/itute products are equival5t to ^? paym5t am\nts outl9$ 9 ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77#i771 reg>dless ( ! site ( c>e 9 :i* ! sk9 sub/itute product is appli$4 #d4 ,enhanc+ program integrity = sk9 sub/itute products ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7aa7 ,special paym5t rules = sk9 sub/itute products 7#a7 ,id5tification ( outli] provid]s ( sk9 sub/itute products 7,a7 ,9 g5]al ,n lat] ?an ,m>* #a1 #bjbf1 & e #b ye>s !reaft] ?r\gh ,m>* #a1 #bjce1 ! ,secret>y %all det]m9e ! #c p]c5t ( ! total numb] ( provid]s ( sk9 sub/itute products t are outli] provid]s ( sk9 sub/itute products4 7,b7 ,outli] provid]s ( sk9 sub/itute products ,! det]m9ation ( an outli] provid] ( sk9 sub/itute products "u ?is p>agraph %all be bas$ ^u ! provid]s 7z id5tifi$ by national provid] id5tification numb]7 t receiv$ ! greate/ total paym5t "u ?is title = sk9 sub/itute products furni%$ 9 ! ye> prec$+ ! ye> 9 :i* ! det]m9ation "u subp>agraph 7,a7 is made4 7,c7 ,ref]ral to oig ,! ,secret>y %all-- 7i7 make publicly available ! li/ ( outli] provid]s ( sk9 sub/itute products id5tifi$ "u ea* det]m9ation "u subp>agraph 7,a72 & 7ii7 transmit su* li/ to ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices = ! assessm5t ( pot5tial fraud1 wa/e1 or abuse4 7#b7 ,initial prepaym5t claim review = c]ta9 outli] provid]s 7,a7 ,9 g5]al ,beg9n+ ,m>* #a1 #bjbf1 ! ,secret>y %all conduct prepaym5t review ( claims = sk9 sub/itute products submitt$ "u ?is title by an outli] provid] ( sk9 sub/itute products unless #a or m ( ! conditions describ$ 9 subp>agraph 7,b7 is met ) respect to su* provid]4 7,b7 ,limitation ,= purposes ( subp>agraph 7,a71 ! conditions describ$ 9 ?is subp>agraph are1 ) respect to an outli] provid] ( sk9 sub/itute products1 ! foll[+3 7i7 ,sk9 sub/itute products furni%$ by ! provid] are subject to prior au?orization "u p>agraph 7#c74 7ii7 ,! rate ( approval = claims = sk9 sub/itute products furni%$ by su* provid] t are subject to prepaym5t review "u ?is p>agraph exce$s #ij p]c5t 7z det]m9$ ov] a p]iod ( "t or numb] ( claims specifi$ by ! ,secret>y74 7iii7 ,! ,secret>y det]m9es t ! bill+ practices ( ! provid] are consi/5t ) ! applicable cov]age crit]ia & requirem5ts "u ?is title4 7#c7 ,prior au?orization = outli] provid]s ( sk9 sub/itute products 7,a7 ,9 g5]al ,beg9n+ n lat] ?an ,janu>y #a1 #bjbg1 subject to subp>agraph 7,b71 ! ,secret>y %all1 = a p]iod det]m9$ appropriate by ! ,secret>y1 apply prior au?orization = sk9 sub/itute products t are furni%$ by an outli] provid] ( sk9 sub/itute products id5tifi$ "u p>agraph 7#a74 7,b7 ,removal f prior au?orization ,9 ! ev5t t ! ,secret>y det]m9es1 ) respect to an outli] provid] ( sk9 sub/itute products1 t ! rate ( approval = reque/s = prior au?orization "u ?is p>agraph = sk9 sub/itute products furni%$ by su* provid] exce$s #ij p]c5t 7z det]m9$ ov] a p]iod ( "t or numb] ( claims specifi$ by ! ,secret>y71 ! ,secret>y may cease to apply prior au?orization "u ?is p>agraph = sk9 sub/itute products furni%$ by su* provid]4 7,c7 ,fund+ ,= purposes ( c>ry+ out ?is p>agraph1 ! ,secret>y %all provide = ! transf]1 f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda1 to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt1 ( #e1jjj1jjj = ea* ( fiscal ye>s #bjbg ?r\gh #bjcj1 to rema9 available until exp5d$4 7#d7 ,enrollm5t revocation or exclusion ( noncompliant outli] provid]s 7,a7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbh1 if ! rate ( d5ial = reque/s = prior au?orization "u p>agraph 7#c7 = sk9 sub/itute products furni%$ by an outli] provid] ( sk9 sub/itute products exce$s #ge p]c5t ov] a p]iod ( #f or m consecutive mon?s1 ! ,secret>y %all det]m9e t an abuse ( bill+ privileges exi/s ) respect to su* provid] = purposes ( section #dbd4ece7;a77#h77;ii7 ( title #db1 ,code ( ,f$]al ,regulations4 7,b7 ,ref]ral = exclusion ,if ! ,secret>y det]m9es "u subp>agraph 7,a7 t an abuse ( bill+ privileges exi/s ) respect to an outli] provid] ( sk9 sub/itute products1 ! ,secret>y %all direct ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices to det]m9e :e!r su* provid] %\ld be exclud$ f p>ticipation 9 any ,f$]al heal? c>e program "u section #aabh7;b77#f74 7#e7 ,sk9 sub/itute product wa/age 7,a7 ,) respect to sk9 sub/itute products furni%$ = ! treatm5t ( *ronic or acute w\nds1 paym5t %all be only made = ! reasonable & necess>y portion ( ! sk9 sub/itute product us$ 9 ! treatm5t ( ! w\nd1 exclud+ wa/age4 7,b7 ,= ! purpose ( subp>agraph 7,a71 ! reasonable & necess>y portion ( ! sk9 sub/itute product is def9$ z ! great] ( 7i7 #c squ>e c5timet]s1 or 7ii7 #abj p]c5t ( ! size ( ! treat$ w\nd4 7#f7 ,sk9 sub/itute product def9$ ,9 ?is subsection1 ! t]m sk9 sub/itute product has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,j74 4 #e4 ,/reaml9+ approval processes = human cells1 tissues & cellul> & tissue-bas$ products 7a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all-- 7#a7 conduct a compreh5sive review ( ! approval process appli$ to human cellul> & tissue allografts & autografts t are n subject to regulation only "u section #cfa ( ! ,public ,heal? ,s]vice ,act1 includ+ ^? process$ into liquid1 gel1 or p[d] =ms2 7#b7 id5tify opportunities to /reaml9e application requirem5ts1 review timel9es1 & evid5ti>y /&>ds = su* products :ile ma9ta9+ appropriate safety & efficacy ov]sight2 7#c7 consid] ! developm5t ( a ti]$ review framework bas$ on risk assessm5t factors includ+ degree ( manipulation1 process+ me?ods1 mode or adm9i/ration1 & cl9ical safety pr(ile2 7#d7 evaluate ! ne$ = pre-m>ket cl9ical evaluation & ! appropriat5ess ( lev]ag+ exi/+ cl9ical data1 real-_w evid5ce1 & regi/ry data to r$uce duplicative cl9ical trial requirem5ts :]e sci5tifically ju/ifi$2 & 7#e7 assess me*anisms to h>monize requirem5ts betwe5 products curr5tly regulat$ only "u section #cfa ( ! ,public ,heal? ,s]vice ,act t may transition to section #cea regulation4 7b7 ,/akehold] consultation ,9 conduct+ ! review "u p>agraph 7#a71 ! ,secret>y %all consult )-- 7#a7 manufactur]s ( human tissue allografts2 7#b7 tissue banks & procurem5t organizations2 7#c7 cl9icians specializ+ 9 w\nd c>e1 surgical recon/ruction1 & reg5]ative m$ic9e2 7#d7 pati5t advocacy organizations2 7#e7 heal? insurance payors2 & 7#f7 relevant sci5tific & m$ical pr(essional societies4 7c7 ,consid]ations ,! review %all specifically consid]-- 7#a7 appropriate modifications to ,*emi/ry1 ,manufactur+1 & ,controls 7,,cmc7 requirem5ts reflect+ ! biological nature & donor-dep5d5t v>iability ( human tissue2 7#b7 pot5tial use ( exp$it$ review pa?ways1 includ+ priority review designations2 7#c7 opportunities = modul> or /ag$ application submissions2 7#d7 appropriate cl9ical endpo9t crit]ia & /udy designs = diff]5t types ( allografts & autografts2 7#e7 po/-m>ket surveillance requirem5ts z an alt]native to pre-m>ket evid5ce requirem5ts2 & 7#f7 int]national regulatory approa*es to simil> products4 7d7 ,guidance ,n lat] ?an #bd mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue draft guidance implem5t+ any /reaml9+ measures id5tifi$ "u subsection 7b71 & %all f9alize su* guidance n lat] ?an #ab mon?s aft] ! close ( ! public comm5t p]iod4 7e7 ,report to congress ,n lat] ?an #cj mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! review conduct$ "u subsection 7b71 includ+-- 7#a7 f9d+s & recomm5dations = regulatory /reaml9+2 7#b7 any adm9i/rative actions tak5 or propos$2 7#c7 recomm5dations = additional legislative action1 if any2 & 7#d7 e/imat$ impacts on pati5t access & public heal?4 7f7 ,pres]vation ( safety /&>ds ,no?+ 9 ?is section %all be con/ru$ to r$uce or elim9ate safety or efficacy /&>ds applicable to human tissue allografts or autografts subject to lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act4