,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #dagh ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,augu/ #i1 #bjai,mr4 ,engel introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,ways & ,means1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d title ,,xviii ( ! ,social ,security ,act to require manufactur]s ( c]ta9 s+le-dose vial drugs payable "u "p ,b ( ! ,m$ic>e program to provide rebates ) respect to am\nts ( su* drugs disc>d$1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,recov]+ ,excessive ,funds = ,unus$ & ,ne$less ,drugs ,act ( #bjai or ! ,,refund ,act ( #bjai4 #b4 ,requir+ manufactur]s ( c]ta9 s+le-dose vial drugs payable "u "p ,b ( ! ,m$ic>e program to provide rebates ) respect to disc>d$ am\nts ( su* drugs 7a7 ,9 g5]al ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7x7 ,rebate = c]ta9 disc>d$ s+le-,dose vial drugs 7#a7 ,9 g5]al ,! manufactur] 7z def9$ 9 section #ahdg;,a7c77#f77;,a77 ( a rebatable s+le-dose vial drug furni%$ 9 a cal5d> qu>t] %all1 n lat] ?an #cj days aft] ! date ( receipt ( in=mation describ$ 9 p>agraph 7#b77;,a77iii7 ) respect to su* qu>t]1 provide to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 p>agraph 7#c7 = su* drug = su* qu>t]4 7#b7 ,secret>ial duties 7,a7 ,9 g5]al ,= ea* cal5d> qu>t]1 ! ,secret>y %all1 ) respect to a rebatable s+le-dose vial drug ( a manufactur] furni%$ dur+ su* qu>t]-- 7i7 require1 ?r\gh use ( a modifi] su* z ! ,,jw modifi] us$ z ( ! date ( enactm5t ( ?is subsection 7or any su* successor code t includes su* data z det]m9$ appropriate by ! ,secret>y71 an indication on a claim = su* drug ( ! am\nt ( su* drug t 0 disc>d$ aft] su* drug 0 furni%$1 if any2 7ii7 det]m9e ! rebatable am\nt 7z def9$ 9 subp>agraph 7,b77 ) respect to su* drug2 & 7iii7 n lat] ?an #fj days aft] ! end ( su* qu>t]1 provide to su* manufactur] notice (-- 7,i7 ! total numb] ( units ( su* drug disc>d$ dur+ su* qu>t] 7z det]m9$ by ! ,secret>y bas$ on ! aggregate rebatable am\nt 7z s def9$7 ) respect to su* drug = su* qu>t]71 if any2 & 7,,ii7 ! rebate am\nt specifi$ 9 p>agraph 7#c7 = su* drug & su* qu>t]4 7,b7 ,rebatable am\nt ,! t]m rebatable am\nt means1 ) respect to a rebatable s+le-dose vial drug ( a manufactur] furni%$ dur+ a qu>t]1 #ij p]c5t ( ! am\nt 7if any7 ( su* drug t 0 disc>d$ z indicat$ pursuant to subp>agraph 7,a77i74 7#c7 ,rebate am\nt ,! am\nt ( ! rebate specifi$ 9 ?is p>agraph is1 ) respect to a rebatable s+le-dose vial drug ( a manufactur] furni%$ 9 a cal5d> qu>t]1 an am\nt equal to ! product (-- 7,a7 ! total numb] ( units ( su* drug disc>d$ dur+ su* qu>t] z det]m9$ "u p>agraph 7#b77;,a77iii77,i72 & 7,b7 ! less] (-- 7i7 ! av]age sales price 7z def9$ 9 section #ahdg;,a7c77#a77 = a unit ( su* drug = su* qu>t] 7or1 9 ! case ( a drug subject to an agreem5t ) su* manufactur] "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act1 ! price = a unit ( su* drug = su* qu>t] "u su* agreem5t72 or 7ii7 ! :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77;,b77 = a unit ( su* drug4 7#d7 ,rebate deposits ,am\nts paid z rebates pursuant to p>agraph 7#a7 %all be deposit$ into ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda4 7#e7 ,en=cem5t 7,a7 ,audits ,ea* manufactur] ( a rebatable s+le dose-vial drug t is requir$ to provide a rebate "u ?is subsection %all be subject to p]iodic audit ) respect to su* drug & su* rebates by ! ,secret>y4 7,b7 ,civil money p5alty 7i7 ,9 g5]al ,! ,secret>y %all impose a civil money p5alty on a manufactur] ( a rebatable s+le dose-vial drug :o has fail$ to comply ) ! requirem5t "u p>agraph 7#a7 = su* drug = a cal5d> qu>t] 9 an am\nt ! ,secret>y det]m9es is comm5surate ) ! sum (-- 7,i7 ! am\nt t ! manufactur] w\ld h paid "u su* p>agraph ) respect to su* drug = su* qu>t]2 & 7,,ii7 #be p]c5t ( su* am\nt4 7ii7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7#f7 ,def9itions ,9 ?is subsection3 7,a7 ,rebatable s+le-dose vial drug ,! t]m rebatable s+le-dose vial drug means a s+le s\rce drug or biological 7z def9$ 9 section #ahdg;,a7c77#f77;,d77 paid = "u ?is "p & furni%$ on or aft] ,janu>y #a1 #bjbj1 f a s+le-dose vial4 7,b7 ,unit ,! t]m unit has ! mean+ giv5 su* t]m 9 section #ahdg;,a7b77#b77;,b74 4 7b7 ,collection ( co9surance only = portion ( rebatable s+le-,dose vial drug adm9i/]$ ,section #ahcc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is am5d$-- 7#a7 9 subsection 7a77#a77,s71 by ins]t+ subject to subsection 7cc71 be=e ) respect to2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7cc7 ,collection ( co9surance only = portion ( rebatable s+le-,dose vial drug adm9i/]$ ,:5 process+ a claim = a rebatable s+le-dose vial drug 7z def9$ 9 section #ahcd7w77#f771 ! ,secret>y1 act+ ?r\gh ! relevant ,m$ic>e adm9i/rative contractor ) respect to su* claim1 %all only collect co9surance f a b5efici>y1 tak+ into acc\nt any cov]age "u a ,m$ic>e supplem5tal policy c]tifi$ "u section #ahhb or any o!r supplem5tal insurance cov]age ( ! b5efici>y1 ) respect to ! portion ( ! drug adm9i/]$ 7z indicat$ by ! ,j-portion ( ! claim = ! drug us$ z ( ! date ( enactm5t ( ?is subsection1 or any successor code t includes su* data z det]m9$ appropriate by ! ,secret>y71 9 an am\nt equal to #bj p]c5t ( ! am\nt ( paym5t t w\ld be made if paym5t = ! claim 0 bas$ only on ! portion ( ! drug adm9i/]$ 7z s indicat$74 ,no?+ 9 ! prec$+ s5t5ce %all affect ! am\nt paid to ! provid] ( s]vices or suppli] ) respect to ! drug "u ?is "p 7z det]m9$ bas$ on ! total am\nt ( ! drug = :i* ! claim 0 submitt$1 includ+ ! portion ( ! drug adm9i/]$ & ! portion disc>d$1 z indicat$ by ! ,j-portion ( ! claim & ! ,,jw modifi]1 respectively1 us$ z ( su* date ( enactm5t or any successor codes t include su* data z det]m9$ appropriate by ! ,secret>y74 4