,,ii #aai? ,,congress #a/ ,session ,s4 #befa ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #ca1 #bjbe,mr4 ,cassidy introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d title ,,xviii ( ! ,social ,security ,act to re=m ! paym5t rules reg>d+ sk9 sub/itute products4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,sk9 ,sub/itute ,access & ,paym5t ,re=m ,act ( #bjbe4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,sk9 sub/itute products are advanc$ biological !rapies us$ to treat *ronic1 non-heal+ w\nds1 su* z diabetic foot ulc]s & v5\s leg ulc]s4 ,ea* ye>1 m ?an #aj1ejj1jjj ,m$ic>e b5efici>ies w require m$ical c>e = treatm5t ( a w\nd4 ,by improv+ heal+ rates & r$uc+ ! rate ( l[] limb amputation1 sk9 sub/itute products improve ! heal? & wellness ( ,m$ic>e b5efici>ies4 7#b7 ,^! treatm5ts v>y 9 makeup & s\rce mat]ial1 includ+ human tissue-d]iv$ products1 non-human1 animal-d]iv$ products1 & syn!tic products4 ,/udies %[ t diff]5t sk9 sub/itute products are simil>ly safe & effective 9 treat+ *ronic w\nds1 & ,m$ic>e cov]age does n curr5tly diff]5tiate betwe5 diff]5t types ( lawfully m>ket$ sk9 sub/itutes4 ,heal?c>e provid]s are well-in=m$ ab\t alt]native sk9 sub/itute products & are 9 ! be/ position to det]m9e :i* specific product w\ld be/ suit ea* specific pati5t bas$ on ! pati5t's specific ne$s & ! provid]'s k & exp]i5ce4 7#c7 ,! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices has fac$ *all5ges 9 det]m9+ consi/5t & accurate pric+ & paym5t = s]vices t involve sk9 sub/itute products1 result+ 9 unc]ta9ty & significant price diff]5ces among ^! products4 7#d7 ,! ,m$ic>e paym5t sy/ems 9 place at ! date ( enactm5t ( ?is ,act inc5tivize use ( m exp5sive products & cont9u$ price increases :ile fail+ to recognize ! simil> cl9ical effects ( sk9 sub/itute products4 ,m$ic>e exp5ditures = sk9 sub/itute products rose significantly 9 #bjbd & #bjbe4 7#e7 ,x is !re=e necess>y to re=m ! ,m$ic>e paym5t & cov]age rules = sk9 sub/itute products to appropriately recognize ! well-e/abli%$ & kn[n cl9ical value ( ^! treatm5ts :ile conta9+ co/s4 #c4 ,paym5t re=m = sk9 sub/itute products 7a7 ,9 g5]al ,section #ahdg;,a7b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 subp>agraph 7,b71 by /rik+ or at ! end2 7,b7 9 subp>agraph 7,c71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 9 ! case ( a sk9 sub/itute product 7z def9$ 9 subsection 7c77#f77;,j771 ! am\nt det]m9$ "u p>agraph 7#i74 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,sk9 sub/itute products 7,a7 ,9 g5]al ,beg9n+ on ,janu>y #a1 #bjbf1 = any sk9 sub/itute product 7z def9$ 9 subsection 7c77#f771 ! am\nt specifi$ 9 ?is p>agraph is ! volume-weight$ av]age ( ! paym5t all[ance limit calculat$ "u subp>agraph 7,b74 7,b7 ,volume-weight$ av]age paym5t limit ,! volume-weight$ av]age ( ! paym5t all[ance limit ( a sk9 sub/itute product "u ?is p>agraph is det]m9$ by-- 7i7 calculat+ ! sum ( ! products (-- 7,i7 ! publi%$ paym5t all[ance limit = ea* bill+ & paym5t code li/$ 9 ! ,,asp ,pric+ ,file publi%$ by ! ,secret>y = ! f\r? cal5d> qu>t] ( #bjbc = ea* sk9 sub/itute product2 & 7,,ii7 ! total numb] ( units1 z specifi$ "u p>agraph 7#b71 = ea* bill+ & paym5t code describ$ 9 subclause 7,i71 bill$ ) dates ( s]vice f ,octob] #a1 #bjbc1 to ,decemb] #ca1 #bjbc1 & li/$ 9 ! ,integrat$ ,data ,repository = ,"p ,b claims data2 & 7ii7 divid+ ! sum calculat$ "u clause 7i7 by ! total numb] ( units "u subclause 7,,ii74 7,c7 ,updates to paym5t am\nts ,= #bjbg & ea* subsequ5t ye>1 ! am\nt specifi$ 9 ?is p>agraph %all be adju/$ = ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,u4,s4 city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( ! previ\s ye>4 4 7b7 ,def9ition & o!r rules = sk9 sub/itute products ,section #ahdg;,a7c77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,j7 ,sk9 sub/itute products 7i7 ,9 g5]al ,! t]m sk9 sub/itute product-- 7,i7 means a cellul>1 biological or syn!tic mat]ial or tissue appli$ to a w\nd & int5d$ to rema9 )9 ! w\nd b$1 includ+ a product approv$1 cle>$1 or au?oriz$ to section #eaj7k71 #eac7;f77#b71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k71 #bfj;c7f77#b71 #cfj;e7 or section #cfa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfd71 & _! implem5t+ regulations2 & 7,,ii7 does n include-- 7aa7 any product t is int5d$ to tempor>ily protect or cov] ! w\nd b$ & be remov$ be=e complete resorption1 su* z a dress+2 7bb7 any liquid1 gel1 p[d]1 or o!r simil>ly con/itut$ item2 or 7cc7 any product t w\ld o!rwise meet ! requirem5ts ( subclause 7,i71 b is approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a774 7ii7 ,consolidat$ bill+ & paym5t code ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y %all e/abli% a new bill+ & paym5t code = all sk9 sub/itute products4 7iii7 ,special rules ,beg9n+ on ,janu>y #a1 #bjbf1 ! foll[+ rules %all apply3 7,i7 ,ea* sk9 sub/itute product %all be subject to ! same crit]ia :5 det]m9+ :e!r su* sk9 sub/itute product is reasonable & necess>y = ! diagnosis or treatm5t ( illness or injury "u section #ahfb7;a77#a77;,a71 unless det]m9$ by ! ,secret>y t su* product is unsafe bas$ on evid5ce ( contam9ation1 s]i\s infecti\s disease1 or s]i\s adv]se reactions caus$ by su* product4 7,,ii7 ,! ,secret>y may n det]m9e t a sk9 sub/itute product is n consid]$ reasonable & necess>y = ! diagnosis or treatm5t ( illness or injury "u section #ahfb7;a77#a77;,a7 bas$ solely on analysis ( any cl9ical evid5ce relat+ to su* product4 7,,iii7 ,a manufactur] ( a sk9 sub/itute product %all n be requir$ to report ! av]age sales price = su* product "u section #aibg7;b77#c77;,a77iii7 or subsection 7f77#b74 4