,,ii #aae? ,,congress #a/ ,session ,s4 #cdh ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,febru>y #i1 #bjag ,mr4 ,frank5 7= himself1 ,mr4 ,re$1 & ,mr4 ,br[n7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d title ,,xviii ( ! ,social ,security ,act to require ! ,secret>y ( ,heal? & ,human ,s]vices to negotiate l[] cov]$ "p ,d drug prices on behalf ( ,m$ic>e b5efici>ies4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,prescription ,drug & ,heal? ,improvem5t ,act ( #bjag4 #b4 ,negotiat+ fair prices = ,m$ic>e prescription drugs 7a7 ,negotiat+ fair prices 7#a7 ,9 g5]al ,section #ahfj;,d-#aa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$ by /rik+ subsection 7i7 7relat+ to non9t]f]5ce7 & by ins]t+ ! foll[+3 7i7 ,negotiat+ fair prices ) drug manufactur]s 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 9 fur!rance ( ! goals ( provid+ quality c>e & conta9+ co/s "u ?is "p1 ! ,secret>y %all1 ) respect to applicable cov]$ "p ,d drugs1 & may1 ) respect to o!r cov]$ "p ,d drugs1 negotiate1 us+ ! negotiation te*nique t ! ,secret>y det]m9es w maximize sav+s & value = a cov]$ "p ,d drug & plan enrollees 79 a mann] t may be simil> to ,f$]al entities & t may include1 b is n limit$ to1 =mul>ies1 ref]5ce pric+1 disc\nts1 rebates1 & o!r price concessions71 ) drug manufactur]s ! prices t may be *>g$ to ,,pdp sponsors & ,,ma organizations = su* drugs = "p ,d eligible individuals :o are enroll$ 9 a prescription drug plan or 9 an ,,ma-,,pd plan4 ,9 conduct+ su* negotiations1 ! ,secret>y %all consid] ! drug's curr5t price1 initial laun* price1 preval5ce & usage1 & approv$ indications1 ! numb] ( simil>ly effective alt]native treatm5ts = ea* approv$ use ( ! drug1 ! budget>y impact ( provid+ cov]age "u ?is "p = su* drug = all individuals :o w\ld likely b5efit f ! drug1 & evid5ce on ! drug's effectiv5ess comp>$ to simil> drugs4 7#b7 ,use ( l[] ( ,,va or big f\r price if negotiations fail ,if1 aft] attempt+ to negotiate = a price ) respect to a cov]$ "p ,d drug "u p>agraph 7#a7 = a p]iod ( #a ye>1 ! ,secret>y is n successful 9 obta9+ an appropriate price = ! drug 7z det]m9$ by ! ,secret>y71 ! ,secret>y %all e/abli% ! price t may be *>g$ to ,,pdp sponsors & ,,ma organizations = su* drug = "p ,d eligible individuals :o are enroll$ 9 a prescription drug plan or 9 an ,,ma-,,pd plan at an am\nt equal to ! less] (-- 7,a7 ! price paid by ! ,secret>y ( ,vet]ans ,affairs to procure ! drug "u ! laws adm9i/]$ by ! ,secret>y ( ,vet]ans ,affairs2 or 7,b7 ! price paid to procure ! drug "u section #habf ( title #ch1 ,unit$ ,/ates ,code4 7#c7 ,applicable cov]$ "p ,d drug def9$ ,= purposes ( ?is subsection1 ! t]m applicable cov]$ "p ,d drug means a cov]$ "p ,d drug t ! ,secret>y det]m9es to be appropriate = negotiation "u p>agraph 7#a7 bas$ on "o or m ( ! foll[+ factors z appli$ to su* drug3 7,a7 ,sp5d+ on a p] b5efici>y basis4 7,b7 ,sp5d+ "u ?is title4 7,c7 ,unit price increases ov] ! prec$+ ye>s4 7,d7 ,initial laun* price4 7,e7 ,availability ( simil>ly effective alt]native treatm5ts4 7,f7 ,/atus ( ! drug z a foll[-on to previ\sly approv$ drugs4 7,g7 ,any o!r crit]ia det]m9$ by ! ,secret>y4 7#d7 ,,pdp sponsors & ,,ma organization may negotiate l[] prices ,no?+ 9 ?is subsection %all be con/ru$ z prev5t+ ! sponsor ( a prescription drug plan1 or an organization (f]+ an ,,ma-,,pd plan1 f obta9+ a disc\nt or r$uction ( ! price = a cov]$ "p ,d drug bel[ ! price negotiat$ "u p>agraph 7#a7 or ! price e/abli%$ "u p>agraph 7#b74 7#e7 ,no affect on exi/+ appeals process ,no?+ 9 ?is subsection %all be con/ru$ to affect ! appeals proc$ures "u subsections 7g7 & 7h7 ( section #ahfj;,d-#d4 4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all take effect on ! date ( ! enactm5t ( ?is ,act & %all fir/ apply to negotiations & prices = plan ye>s beg9n+ on ,janu>y #a1 #bjai4 7b7 ,reports to ,congress 7#a7 ,secret>y ( ,,hhs 7,a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 & e #f mon?s !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report on ! foll[+3 7i7 ,! negotiations conduct$ by ! ,secret>y "u section #ahfj;,d-#aa7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i771 z am5d$ by subsection 7a71 includ+ a description ( h[ su* negotiations are a*iev+ l[] prices = cov]$ "p ,d drugs 7z def9$ 9 section #ahfj;,d-#b7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e777 = ,m$ic>e b5efici>ies4 7ii7 ,data on sp5d+ "u "p ,d ( ! ,m$ic>e program on cov]$ "p ,d drugs1 includ+ data on cov]$ "p ,d drugs )-- 7,i7 sp5d+ on a p] b5efici>y basis t is above ! m$ian sp5d+ on o!r drugs 9 ! same class or above ! m$ian sp5d+ ( o!r drug classes2 & 7,,ii7 high unit co/ increases ov] ! pa/ five ye>s1 especially :]e su* increases are great] ?an ! increases = cov]$ "p ,d drugs 9 g5]al4 7iii7 ,a li/ ( ! cov]$ "p ,d drugs ) no !rapeutic sub/itute & data on sp5d+ "u "p ,d ( ! ,m$ic>e program on su* drugs4 7iv7 ,access to cov]$ "p ,d drugs4 7v7 ,appeals by enrollees ) respect to cov]$ "p ,d drugs n includ$ on plan =mul>ies4 7,b7 ,public availability ( report ,! ,secret>y ( ,heal? & ,human ,s]vices %all publi% on ! ,int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices a copy ( ea* report submitt$ "u subp>agraph 7,a74 7#b7 ,med,p,a,c 7,a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! negotiations conduct$ by ! ,secret>y "u section #ahfj;,d-#aa7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i771 z am5d$ by subsection 7a71 includ+ a description ( h[ su* negotiations are a*iev+ l[] prices = cov]$ "p ,d drugs 7z def9$ 9 section #ahfj;,d-#b7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e777 = ,m$ic>e b5efici>ies4 7,b7 ,report ,n lat] ?an ,janu>y #a1 #bjbb1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report on ! /udy conduct$ "u subp>agraph 7,a71 toge!r ) recomm5dations = improv+ su* negotiations4 7c7 ,,cmi te/+ ( negotiat+ drug & biological prices ,to improve value ,section #aaae;,a7b77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by add+ at ! end ! foll[+ new s5t5ce3 ,! models select$ "u ?is subp>agraph %all include at lea/ #c ( ! models describ$ 9 subp>agraph 7,d71 :i* %all be implem5t$ by n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ! ,prescription ,drug & ,heal? ,improvem5t ,act ( #bjag2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,models ( negotiat+ drug & biological prices to improve value ,! models describ$ 9 ?is subp>agraph are ! foll[+ models = negotiat+ drug & biological prices "u ! applicable titles 7includ+ "u bo? p>ts ,b & ,d ( title ,,xviii7 9 ord] to improve ! value ( paym5ts = su* drugs & biologicals "u su* titles3 7i7 ,disc\nt+ or elim9at+ pati5t co/-%>+ on high-value drugs & biologicals4 7ii7 ,value-bas$ =mul>ies4 7iii7 ,indications-bas$ pric+4 7iv7 ,ref]5ce pric+4 7v7 ,risk-%>+ agreem5ts bas$ on outcomes4 7vi7 ,pric+ bas$ on comp>ative effectiv5ess rese>*4 7vii7 ,episode-bas$ paym5ts = *emo!rapy & o!r conditions det]m9$ appropriate by ! ,secret>y4 4