,,ii #aaf? ,,congress #a/ ,session ,s4 #bje ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,janu>y #bd1 #bjai,mr4 ,wyd5 7= himself & ,mr4 ,grassley7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d title ,,xix ( ! ,social ,security ,act to prev5t ! misclassification ( drugs = purposes ( ! ,m$icaid drug rebate program4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,"r ,rebate ,act ( #bjai4 #b4 ,prev5t+ ! misclassification ( drugs "u ! ,m$icaid drug rebate program 7a7 ,application ( civil money p5alty = misclassification ( cov]$ outpati5t drugs 7#a7 ,9 g5]al ,section #aibg7;b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77 is am5d$-- 7,a7 9 ! p>agraph head+1 by ins]t+ & drug product aft] price2 7,b7 9 subp>agraph 7,a7-- 7i7 9 clause 7ii71 by /rik+ 2 & at ! end & ins]t+ a semicolon2 7ii7 9 clause 7iii71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 7iii7 9 clause 7iv71 by /rik+ ! semicolon at ! end & ins]t+ 2 &2 & 7iv7 by ins]t+ aft] clause 7iv7 ! foll[+ new clause3 7v7 n lat] ?an #cj days aft] ! la/ day ( ea* mon? ( a rebate p]iod "u ! agreem5t1 su* drug product in=mation z ! ,secret>y %all require = ea* ( ! manufactur]'s cov]$ outpati5t drugs4 2 7,c7 9 subp>agraph 7,c7-- 7i7 9 clause 7ii71 by ins]t+ 1 includ+ in=mation relat$ to drug pric+1 drug product in=mation1 & data relat$ to drug pric+ or drug product in=mation1 aft] provides false in=mation2 & 7ii7 by add+ at ! end ! foll[+ new clauses3 7iii7 ,misclassifi$ or misreport$ in=mation 7,i7 ,9 g5]al ,any manufacturer ) an agreem5t "u ?is section t kn[+ly 7z def9$ 9 section #ajjc4aaj ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation77 misclassifies a cov]$ outpati5t drug1 su* z by kn[+ly submitt+ incorrect drug category in=mation1 is subject to a civil money p5alty = ea* cov]$ outpati5t drug t is misclassifi$ 9 an am\nt n to exce$ #b times ! am\nt ( ! diff]5ce1 z det]m9$ by ! ,secret>y1 betwe5-- 7aa7 ! total am\nt ( rebates t ! manufactur] paid ) respect to ! drug to all ,/ates = all rebate p]iods dur+ :i* ! drug 0 misclassifi$2 & 7bb7 ! total am\nt ( rebates t ! manufactur] w\ld h be5 requir$ to pay1 z det]m9$ by ! ,secret>y1 ) respect to ! drug to all ,/ates = all rebate p]iods dur+ :i* ! drug 0 misclassifi$ if ! drug _h be5 correctly classifi$4 7,,ii7 ,o!r p5alties & recov]y ( und]paid rebates ,! civil money p5alties describ$ 9 subclause 7,i7 are 9 addition to o!r p5alties z may be prescrib$ by law & any o!r recov]y ( ! und]ly+ und]paym5t = rebates due "u ?is section or ! t]ms ( ! rebate agreem5t z det]m9$ by ! ,secret>y4 7iv7 ,increas+ ov]sight & en=cem5t ,ea* ye> ! ,secret>y %all reta91 9 addition to any am\nt reta9$ by ! ,secret>y to rec\p inve/igation & litigation co/s relat$ to ! en=cem5t ( ! civil money p5alties "u ?is subp>agraph & subsection 7c77#d77;,b77ii77,,iii71 an am\nt equal to #be p]c5t ( ! total am\nt ( civil money p5alties collect$ "u ?is subp>agraph & subsection 7c77#d77;,b77ii77,,iii7 = ! ye>1 & su* reta9$ am\nt %all be available to ! ,secret>y1 )\t fur!r appropriation & until exp5d$1 = activities relat$ to ! ov]sight & en=cem5t ( ?is section & agreem5ts "u ?is section1 includ+-- 7,i7 improv+ drug data report+ sy/ems2 7,,ii7 evaluat+ & ensur+ manufactur] compliance ) rebate obligations2 & 7,,iii7 ov]sight & en=cem5t relat$ to ensur+ t manufactur]s accurately & fully report drug in=mation1 includ+ data relat$ to drug classification4 2 & 7iii7 9 subp>agraph 7,d7-- 7,i7 9 clause 7iv71 by /rik+ 2 & & ins]t+ a comma2 7,,ii7 9 clause 7v71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iii7 by ins]t+ aft] clause 7v7 ! foll[+ new clause3 7vi7 9 ! case ( categories ( drug product or classification in=mation t 7 n consid]$ confid5tial by ! ,secret>y on ! day be=e ! date ( ! enactm5t ( ! ,"r ,rebate ,act ( #bjai4 4 7#b7 ,te*nical am5dm5ts 7,a7 ,section #aijc7;i77#aj7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#aj77 is am5d$-- 7i7 9 subp>agraph 7,c7-- 7,i7 by adju/+ ! left m>g9 s z to align ) ! left m>g9 ( subp>agraph 7,b72 & 7,,ii7 by /rik+ 1 & & ins]t+ a semicolon2 7ii7 9 subp>agraph 7,d71 by /rik+ 2 or & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ) respect to any am\nt exp5d$ = a cov]$ outpati5t drug = :i* a susp5sion "u section #aibg7;c77#d77;,b77ii77,,ii7 is 9 effect2 or 4 7,b7 ,section #aibg7;b77#c77;,c77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,c77ii77 is am5d$ by /rik+ subsections 7a7 & 7b7 & ins]t+ subsections 7a71 7b71 7f77#c71 & 7f77#d74 7b7 ,recov]y ( unpaid rebate am\nts due to misclassification ( cov]$ outpati5t drugs 7#a7 ,9 g5]al ,section #aibg7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,recov]y ( unpaid rebate am\nts due to misclassification ( cov]$ outpati5t drugs 7,a7 ,9 g5]al ,if ! ,secret>y det]m9es t a manufactur] ) an agreem5t "u ?is section paid a l[] p]-unit rebate am\nt to a ,/ate = a rebate p]iod z a result ( ! misclassification by ! manufactur] ( a cov]$ outpati5t drug 7)\t reg>d to :e!r ! manufactur] kn[+ly made ! misclassification or %\ld h kn[n t ! misclassification w\ld be made7 ?an ! p]-unit rebate am\nt t ! manufactur] w\ld h paid to ! ,/ate if ! drug _h be5 correctly classifi$1 ! manufactur] %all pay to ! ,/ate an am\nt equal to ! product (-- 7i7 ! diff]5ce betwe5-- 7,i7 ! p]-unit rebate am\nt paid to ! ,/ate = ! p]iod2 & 7,,ii7 ! p]-unit rebate am\nt t ! manufactur] w\ld h paid to ! ,/ate = ! p]iod1 z det]m9$ by ! ,secret>y1 if ! drug _h be5 correctly classifi$2 & 7ii7 ! total units ( ! drug paid = "u ! ,/ate plan 9 ! p]iod4 7,b7 ,au?ority to correct misclassifications 7i7 ,9 g5]al ,if ! ,secret>y det]m9es t a manufactur] ) an agreem5t "u ?is section has misclassifi$ a cov]$ outpati5t drug 7)\t reg>d to :e!r ! manufactur] kn[+ly made ! misclassification or %\ld h kn[n t ! misclassification w\ld be made71 ! ,secret>y %all notify ! manufactur] ( ! misclassification & require ! manufactur] to correct ! misclassification 9 a timely mann]4 7ii7 ,en=cem5t ,if1 aft] receiv+ notice ( a misclassification f ! ,secret>y "u clause 7i71 a manufactur] fails to correct ! misclassification by su* "t z ! ,secret>y %all require1 until ! manufactur] makes su* correction1 ! ,secret>y may-- 7,i7 correct ! misclassification on behalf ( ! manufactur]2 7,,ii7 susp5d ! misclassifi$ drug & ! drug's /atus z a cov]$ outpati5t drug "u ! manufactur]'s national rebate agreem5t2 or 7,,iii7 impose a civil money p5alty 7:i* %all be 9 addition to any o!r recov]y or p5alty :i* may be available "u ?is section or any o!r provision ( law7 = ea* rebate p]iod dur+ :i* ! drug is misclassifi$ n to exce$ an am\nt equal to ! product (-- 7aa7 ! total numb] ( units ( ea* dosage =m & /r5g? ( su* misclassifi$ drug paid = "u any ,/ate plan dur+ su* a rebate p]iod2 & 7bb7 #bc4a p]c5t ( ! av]age manufactur] price = ! dosage =m & /r5g? ( su* misclassifi$ drug4 7,c7 ,report+ & transp>5cy 7i7 ,9 g5]al ,! ,secret>y %all submit a report to ,congress on at lea/ an annual basis t includes in=mation on ! cov]$ outpati5t drugs t h be5 id5tifi$ z misclassifi$1 ! /eps tak5 to reclassify su* drugs1 ! actions ! ,secret>y has tak5 to ensure ! paym5t ( any rebate am\nts :i* 7 unpaid z a result ( su* misclassification1 & a disclosure ( exp5ditures f ! fund creat$ 9 subsection 7b77#c77;,c77iv71 includ+ an acc\nt+ ( h[ su* funds h be5 allocat$ & sp5t 9 accordance ) su* subsection4 7ii7 ,public access ,! ,secret>y %all make ! in=mation conta9$ 9 ! report requir$ "u clause 7i7 available to ! public on a timely basis4 7,d7 ,o!r p5alties & actions ,actions tak5 & p5alties impos$ "u ?is clause %all be 9 addition to o!r rem$ies available to ! ,secret>y includ+ t]m9at+ ! manufactur]'s rebate agreem5t = noncompliance ) ! t]ms ( su* agreem5t & %all n exempt a manufactur] f1 or preclude ! ,secret>y f pursu+1 any civil money p5alty "u ?is title or title ,,xi1 or any o!r p5alty or action z may be prescrib$ by law4 4 7#b7 ,(fset ( recov]$ am\nts aga9/ m$ical assi/ance ,section #aibg7;b77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#a77;,b77 is am5d$ by ins]t+ 1 includ+ am\nts receiv$ by a ,/ate "u subsection 7c77#d71 aft] 9 any qu>t]4 7c7 ,cl>ify+ def9itions ,section #aibg7k77#g77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#g77;,a77 is am5d$-- 7#a7 by /rik+ an orig9al new drug application & ins]t+ a new drug application ea* place x appe>s2 7#b7 9 clause 7i71 by ins]t+ b includ+ a drug product approv$ = m>ket+ z a non-prescription drug t is reg>d$ z a cov]$ outpati5t drug "u p>agraph 7#d7 aft] drug describ$ 9 p>agraph 7#e72 7#c7 9 clause 7ii71 by /rik+ 0 orig9ally m>ket$ & ins]t+ is m>ket$2 & 7#d7 9 clause 7iv7-- 7,a7 by ins]t+ 1 includ+ a drug product approv$ = m>ket+ z a non-prescription drug t is reg>d$ z a cov]$ outpati5t drug "u p>agraph 7#d71 aft] cov]$ outpati5t drug2 & 7,b7 by add+ at ! end ! foll[+ new s5t5ce3 ,su* t]m also includes a cov]$ outpati5t drug t is a biological product lic5s$1 produc$1 or di/ribut$ "u a biologics lic5se application approv$ by ! ,food & ,drug ,adm9i/ration44 7d7 ,exclusion ( manufactur]s = kn[+ misclassification ( cov]$ outpati5t drugs ,section #aabh7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#ag7 ,kn[+ly misclassify+ cov]$ outpati5t drugs ,any manufactur] or (fic]1 director1 ag5t1 or manag+ employee ( su* manufactur] t kn[+ly misclassifies a cov]$ outpati5t drug "u an agreem5t "u section #aibg1 kn[+ly fails to correct su* misclassification1 or kn[+ly provides false in=mation relat$ to drug pric+1 drug product in=mation1 or data relat$ to drug pric+ or drug product in=mation4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! date ( ! enactm5t ( ?is ,act1 & %all apply to cov]$ outpati5t drugs suppli$ by manufactur]s "u agreem5ts "u section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 on or aft] su* date4