,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #ebci ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,novemb] #ba1 #bjai,mr4 ,joyce ( ,ohio introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to require report+ on prescription drug exp5ditures "u gr\p heal? plans & on prescription drug price *anges1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,prescription ,drug ,price ,report+ ,act4 #b4 ,prescription drug price report+ requirem5ts 7a7 ,submission ( data 7#a7 ,9 g5]al ,ea* manufactur] ( a prescription drug %all submit to ! ,secret>y1 electronically1 9 su* mann] z ! ,secret>y may require1 by ,april #a ( ea* ye>1 a li/ ( ea* su* drug t is m>ket$ 9 ! ,unit$ ,/ates &1 ) respect to ea* su* drug1 all ( ! foll[+ in=mation ) respect to ! previ\s ye>3 7,a7 ,ea* applicable ,national ,drug ,code 7or ,j-,code74 7,b7 ,br& "n4 7,c7 ,g5]ic "n & *emical "n1 z applicable4 7,d7 ,!rapeutic class or classes1 z applicable4 7,e7 ,curr5t :olesale acquisition co/ p] #cj-;day supply or typical c\rse ( treatm5t4 7,f7 ,av]age :olesale acquisition co/ = ! drug p] #cj-;day supply or typical c\rse ( treatm5t dur+ ! previ\s cal5d> ye>1 or1 9 ! case ( a drug t has be5 m>ket$ = only a portion ( su* ye>1 dur+ ! portion ( "t 9 su* ye> t ! drug 0 m>ket$4 7,g7 ,av]age net price p] #cj-;day supply or typical c\rse ( treatm5t1 dur+ ! previ\s cal5d> ye>1 or1 9 ! case ( a drug t has be5 m>ket$ = only a portion ( su* ye>1 dur+ ! portion ( "t 9 su* ye> t ! drug 0 m>ket$1 tak+ into acc\nt all disc\nts1 rebates1 & o!r fees or paym5ts to heal? insurance plans or ph>macy b5efit manag]s ) respect to sales ( ! drug to individuals cov]$ by su* a plan4 7,h7 ,total rebates & o!r paym5ts to heal? insurance plans or ph>macy b5efit manag]s1 p] #cj-;day supply or typical c\rse ( treatm5t1 ) respect to individuals cov]$ by su* a plan1 dur+ ! previ\s cal5d> ye>1 or1 9 ! case ( a drug t has be5 m>ket$ = only a portion ( su* cal5d> ye>1 dur+ ! portion ( "t 9 su* cal5d> ye> t ! drug 0 m>ket$4 7#b7 ,timel9e = initial submission 7,a7 ,drugs m>ket$ be=e ,decemb] #ca1 #bjbj ,ea* manufactur] ( a prescription drug t is m>ket$ at any "t dur+ cal5d> ye> #bjbj1 %all submit to ! ,secret>y1 n lat] ?an ,april #a1 #bjba-- 7i7 ! in=mation requir$ "u p>agraph 7#a72 & 7ii7 9 addition to ! in=mation requir$ "u subp>agraphs 7,f71 7,g71 & 7,h7 ( p>agraph 7#a71 su* av]age :olesale acquisition co/1 av]age net price1 & total rebates & o!r paym5ts1 describ$ 9 ea* ( su* subp>agraphs1 respectively1 ) respect to ! cal5d> ye> imm$iately prec$+ ! cal5d> ye> = :i* su* in=mation is requir$ to be report$ "u su* subp>agraphs 7,f71 7,g71 & 7,h74 7,b7 ,subsequ5tly m>ket$ drugs ,) respect to a prescription drug t is fir/ m>ket$ aft] ,decemb] #ca1 #bjbj1 ea* manufactur] ( su* a drug %all submit ! in=mation requir$ "u subp>agraphs 7,a7 ?r\gh 7,e7 ( p>agraph 7#a7 n lat] ?an #fj days aft] ! date on :i* ! drug is fir/ m>ket$1 & %all submit annual reports ( all ( ! in=mation requir$ "u p>agraph 7#a7 beg9n+ on ! fir/ annual report+ date t is m ?an #cj days aft] ! date on :i* ! drug is fir/ m>ket$4 7b7 ,advance notification ( prescription drug pric+ *anges 7#a7 ,9 g5]al ,ea* manufactur] ( a prescription drug %all report to ! ,secret>y1 electronically1 9 su* mann] z ! ,secret>y may require1 any increase or decrease 9 ! :olesale acquisition co/ ( a prescription drug n lat] ?an #cj days prior to ! date on :i* ! price *ange takes effect4 7#b7 ,cont5t ,a price *ange report "u p>agraph 7#a7 %all include-- 7,a7 ! in=mation requir$ "u subp>agraphs 7,a71 7,b71 7,c71 7,d71 & 7,f7 ( subsection 7a77#a72 7,b7 ! :olesale acquisition co/ p] #cj-;day supply or typical c\rse ( treatm5t imm$iately prior to ! price *ange2 7,c7 ! new :olesale acquisition co/ p] #cj-;day supply or typical c\rse ( treatm5t1 :5 ! *ange takes effect2 & 7,d7 f9ancial & non-f9ancial factors ! manufactur] took into consid]ation :5 mak+ ! price *ange1 includ+ any *anges or improvem5ts to ! drug4 7c7 ,public database 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% an int]net-bas$ sy/em to po/ prescription drug in=mation report$ "u subsection 7a7 & price *ange reports requir$ "u subsection 7b74 7#b7 ,consum] subscription options ,! sy/em e/abli%$ "u p>agraph 7#a7 %all enable consum]s to subscribe to price *ange notifications-- 7,a7 =-- 7i7 all drugs2 7ii7 a p>ticul> drug2 or 7iii7 a p>ticul> !rapeutic class ( drugs2 & 7,b7 t are limit$ to price *anges t are at or ov] a specifi$ am\nt4 7#c7 ,tim+ ,! prescription drug in=mation report$ "u subsection 7a7 %all be made publicly available n lat] ?an #cj days aft] be+ report$ to ! ,secret>y4 ,9 ! case ( a price *ange report requir$ "u subsection 7b71 ! ,secret>y %all make publicly available a notice ( ! price *ange conta9$ 9 su* report on ! day su* *ange takes effect4 7d7 ,privacy protections ,! in=mation submitt$ "u subp>agraphs 7,a7 ?r\gh 7,f7 ( subsection 7a77#a7 & p>agraph 7#b77;,a77ii7 %all be publicly available ?r\gh ! database e/abli%$ "u subsection 7c74 ,no o!r in=mation submitt$ to ! ,secret>y pursuant to subsection 7a7 or 7b7 t is propriet>y1 confid5tial1 or trade secret in=mation %all be includ$ 9 su* database4 7e7 ,def9itions ,= purposes ( ?is section-- 7#a7 ! t]m manufactur] has ! mean+ giv5 su* t]m 9 section #eha ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;eee72 7#b7 ! t]m prescription drug means a drug approv$ section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or a biological product lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 t is subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#a772 7#c7 ! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices2 & 7#d7 ! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a 7c77#f77;,b774 7f7 ,preemption ,effective on ! date t ! public database "u subsection 7b77#c7 fir/ becomes op]ational1 no ,/ate or political subdivision ( a ,/ate may e/abli% or cont9ue 9 effect any law requir+ ! manufactur] to report or make public prescription drug pric+ in=mation4