,,ii #aaf? ,,congress #a/ ,session ,s4 #bjea ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #bh 7legislative day1 ,june #bg71 #bjai,mr4 ,m55dez 7= himself & ,mr4 ,"y7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d ,,xviii ( ! ,social ,security ,act to require c]ta9 manufactur]s to report drug pric+ in=mation ) respect to drugs "u ! ,m$ic>e program4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,/r5g!n+ ,av]age ,sales ,price ,report+ ,act ( #bjai4 #b4 ,requir+ c]ta9 manufactur]s to report drug pric+ in=mation ) respect to drugs "u ! ,m$ic>e program 7a7 ,9 g5]al ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#b77;,a71 by ins]t+ or subsection 7f77#b71 z applicable be=e ! p]iod at ! end2 7,b7 9 p>agraph 7#c71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ or subsection 7f77#b71 z applicable1 be=e det]m9$ by2 & 7,c7 9 p>agraph 7#f77;,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ or subsection 7f77#b71 z applicable1 be=e det]m9$ by2 & 7#b7 9 subsection 7f7-- 7,a7 by /rik+ ,= requirem5ts & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,= requirem5ts 2 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#b7 ,manufactur]s )\t a rebate agreem5t "u title ,,xix 7,a7 ,9 g5]al ,9 ! case ( a manufactur] ( an applicable drug or biological t does n h a rebate agreem5t 9 effect "u section #aibg1 = cal5d> qu>t]s beg9n+ on or aft] ,janu>y #a1 #bjbj1 su* manufactur] %all report to ! ,secret>y ! in=mation describ$ 9 subsection 7b77#c77;,a77iii7 ( su* section #aibg ) respect to su* applicable drug or biological 9 a "t & mann] specifi$ by ! ,secret>y4 7,b7 ,def9ition ( applicable drug or biological ,9 ?is p>agraph1 ! t]m applicable drug or biological means-- 7i7 a drug or biological describ$ 9-- 7,i7 subp>agraph 7,c71 7,e71 or 7,g7 ( section #ahdb7o77#a72 or 7,,ii7 clause 7ii7 or 7iii7 ( section #ahha7;b77#ad77;,b72 & 7ii7 an item = :i* paym5t is e/abli%$ "u ?is section4 7,c7 ,audit ,in=mation report$ "u subp>agraph 7,a7 is subject to audit by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7,d7 ,v]ification ,! ,secret>y may survey :olesal]s & manufactur]s t directly di/ribute an applicable drug or biological1 :5 necess>y1 to v]ify manufactur] prices & manufactur]'s av]age sales prices 7includ+ :olesale acquisition co/7 if requir$ to make paym5t report$ "u subp>agraph 7,a74 ,! ,secret>y may impose a civil monet>y p5alty 9 an am\nt n to exce$ #ajj1jjj on a :olesal]1 manufactur]1 or direct sell]1 if ! :olesal]1 manufactur]1 or direct sell] ( su* a drug refuses a reque/ = in=mation ab\t *>ges or prices by ! ,secret>y 9 connection ) a survey "u ?is subp>agraph or kn[+ly provides false in=mation4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 7) respect to am\nts ( p5alties or additional assessm5ts7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7,e7 ,confid5tiality ,not)/&+ any o!r provision ( law1 in=mation disclos$ by manufactur]s or :olesal]s "u ?is p>agraph 7o!r ?an ! :olesale acquisition co/ = purposes ( c>ry+ out ?is section7 is confid5tial & %all n be disclos$ by ! ,secret>y 9 a =m :i* discloses ! id5tity ( a specific manufactur] or :olesal] or prices *>g$ = an applicable drug or biological by su* manufactur] or :olesal]1 except-- 7i7 z ! ,secret>y det]m9es to be necess>y to c>ry out ?is section 7includ+ ! det]m9ation & implem5tation ( ! paym5t am\nt71 or to c>ry out section #ahdg;,b2 7ii7 to p]mit ! ,comptroll] ,g5]al to review ! in=mation provid$2 & 7iii7 to p]mit ! ,director ( ! ,congressional ,budget ,(fice to review ! in=mation provid$4 4 7b7 ,en=cem5t ,section #ahdg;,a su* ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is fur!r am5d$-- 7#a7 9 subsection 7d77#d7-- 7,a7 9 subp>agraph 7,a71 by /rik+ ,9 g5]al & ins]t+ ,misrepres5tation2 7,b7 9 subp>agraph 7,b71 by /rik+ subp>agraph 7,b7 & ins]t+ subp>agraph 7,a71 7,b71 or 7,c72 7,c7 by r$esignat+ subp>agraph 7,b7 z subp>agraph 7,d72 & 7,d7 by ins]t+ aft] subp>agraph 7,a7 ! foll[+ new subp>agraphs3 7,b7 ,failure to provide timely in=mation ,if ! ,secret>y det]m9es t a manufactur] describ$ 9 subsection 7f77#b7 has fail$ to report on in=mation describ$ 9 section #aibg7;b77#c77;,a77iii7 ) respect to an applicable drug or biological 9 accordance ) su* subsection1 ! ,secret>y %all apply a civil money p5alty 9 an am\nt ( #aj1jjj = ea* day ! manufactur] has fail$ to report su* in=mation & su* am\nt %all be paid to ! ,treasury4 7,c7 ,false in=mation ,any manufactur] requir$ to submit in=mation "u subsection 7f77#b7 t kn[+ly provides false in=mation is subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil money p5alties are 9 addition to o!r p5alties z may be prescrib$ by law4 2 & 7#b7 9 subsection 7c77#f77;,a71 by /rik+ ! p]iod at ! end & ins]t+ 1 except t1 = purposes ( subsection 7f77#b71 ! ,secret>y may1 if ! ,secret>y det]m9es appropriate1 exclude repackag]s ( an applicable drug or biological f su* t]m44 7c7 ,report ,n lat] ?an ,janu>y #a1 #bjba1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all assess & submit to ,congress a report on ! accuracy ( av]age sales price in=mation submitt$ by manufactur]s "u section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a74 ,su* report %all include any recomm5dations on h[ to improve ! accuracy ( su* in=mation4