,,ii #aag? ,,congress #a/ ,session ,s4 #abhg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,april #ba1 #bjba,mr4 ,durb9 7= himself & ,mr4 ,portman7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,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 refunds ) 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$less ,drugs ,act ( #bjba or ! ,,refund ,act ( #bjba4 #b4 ,requir+ manufactur]s ( c]ta9 s+le-dose conta9] or s+le-use package drugs payable "u "p ,b ( ! ,m$ic>e program to provide refunds ) respect to disc>d$ am\nts ( su* drugs ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie-c;a71 z am5d$ by section #dje ( division ,,cc ( ! ,consolidat$ ,appropriations ,act1 #bjba1 is am5d$-- 7#a7 by r$esignat+ subsection 7h7 z subsection 7i72 & 7#b7 ins]t+ aft] subsection 7g7 ! foll[+3 7h7 ,refund = c]ta9 disc>d$ s+le-,dose conta9] or s+le-,use package drugs 7#a7 ,secret>ial provision ( in=mation 7,a7 ,9 g5]al ,= ea* cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjbb1 ! ,secret>y %all1 ) respect to a refundable s+le-dose conta9] or s+le-use package drug 7z def9$ 9 p>agraph 7#h771 report to ea* manufactur] 7z def9$ 9 subsection 7c77#f77;,a77 ( su* refundable s+le-dose conta9] or s+le-use package drug ! foll[+ = ! cal5d> qu>t]3 7i7 ,subject to subp>agraph 7,c71 in=mation on ! total numb] ( units ( ! bill+ & paym5t code ( su* drug1 if any1 t 7 disc>d$ dur+ su* qu>t]1 z det]m9$ us+ a me*anism su* z ! ,,jw modifi] us$ z ( ! date ( enactm5t ( ?is subsection 7or any su* successor modifi] t includes su* data z det]m9$ appropriate by ! ,secret>y74 7ii7 ,! refund am\nt t ! manufactur] is liable = pursuant to p>agraph 7#c74 7,b7 ,det]m9ation ( disc>d$ am\nts ,= purposes ( subp>agraph 7,a77i71 ) respect to a refundable s+le-dose conta9] or s+le-use package drug furni%$ dur+ a qu>t]1 ! am\nt ( su* drug t 0 disc>d$ %all be det]m9$ bas$ on ! am\nt ( su* drug t 0 unus$ & disc>d$ = ea* drug on ! date ( s]vice4 7,c7 ,exclusion ( units ( packag$ drugs ,! total numb] ( units ( ! bill+ & paym5t code ( a refundable s+le-dose conta9] or s+le-use package drug ( a manufactur] furni%$ dur+ a cal5d> qu>t] = purposes ( subp>agraph 7,a77i7 %all n include su* units t are packag$ into ! paym5t am\nt = an item or s]vice & are n sep>ately payable4 7#b7 ,manufactur] requirem5t ,= ea* cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjbb1 ! manufactur] ( a refundable s+le-dose conta9] or s+le-use package drug %all1 = su* drug1 provide to ! ,secret>y a refund t is equal to ! am\nt specifi$ 9 p>agraph 7#c7 = su* drug = su* qu>t]4 7#c7 ,refund am\nt 7,a7 ,9 g5]al ,! am\nt ( ! refund specifi$ 9 ?is p>agraph is1 ) respect to a refundable s+le-dose conta9] or s+le-use package drug ( a manufactur] assign$ to a bill+ & paym5t code = a cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjbb1 an am\nt equal to #ij p]c5t 7or1 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug describ$ 9 subclause 7,i7 or 7,,ii7 ( subp>agraph 7,b77ii71 ! p]c5t det]m9$ = su* drug "u subp>agraph 7,b77i77 ( ! product (-- 7i7 ! total numb] ( units ( ! bill+ & paym5t code = su* drug t 7 disc>d$ dur+ su* qu>t] 7z det]m9$ "u p>agraph 7#a772 & 7ii7 7,i7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug t is a s+le s\rce drug or biological1 ! am\nt det]m9$ = su* drug "u subsection 7b77#d72 or 7,,ii7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug t is a biosimil> biological product1 ! av]age sales price det]m9$ "u subsection 7b77#h77;,a74 7,b7 ,treatm5t ( drugs t require filtration or o!r unique circum/ances 7i7 ,9 g5]al ,! ,secret>y1 ?r\gh notice & comm5t rulemak+-- 7,i7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug describ$ 9 subclause 7,i7 ( clause 7ii71 %all adju/ ! p]c5tage o!rwise applicable = purposes ( det]m9+ ! refund am\nt ) respect to su* drug "u subp>agraph 7,a7 z det]m9$ appropriate by ! ,secret>y2 & 7,,ii7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug describ$ 9 subclause 7,,ii7 ( clause 7ii71 may adju/ ! p]c5tage o!rwise applicable = purposes ( det]m9+ ! refund am\nt ) respect to su* drug "u subp>agraph 7,a7 z det]m9$ appropriate by ! ,secret>y4 7ii7 ,drug describ$ ,= purposes ( clause 7i71 a refundable s+le-dose conta9] or s+le-use package drug describ$ 9 ?is clause is ei!r ( ! foll[+3 7,i7 ,a refundable s+le-dose conta9] or s+le-use package drug = :i* prep>ation in/ructions requir$ & approv$ by ! ,commission] ( ! ,food & ,drug ,adm9i/ration include filtration dur+ ! drug prep>ation process1 prior to dilution & adm9i/ration1 & require t any unus$ portion ( su* drug aft] ! filtration process be disc>d$ aft] ! completion ( su* filtration process4 7,,ii7 ,any o!r refundable s+le-dose conta9] or s+le-use package drug t has unique circum/ances involv+ simil> loss ( product4 7#d7 ,frequ5cy ,am\nts requir$ to be refund$ pursuant to p>agraph 7#b7 %all be paid 9 regul> int]vals 7z det]m9$ appropriate by ! ,secret>y74 7#e7 ,refund deposits ,am\nts paid z refunds pursuant to p>agraph 7#b7 %all be deposit$ into ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda4 7#f7 ,en=cem5t 7,a7 ,audits 7i7 ,manufactur] audits ,ea* manufactur] ( a refundable s+le-dose conta9] or s+le-use package drug t is requir$ to provide a refund "u ?is subsection %all be subject to p]iodic audit ) respect to su* drug & su* refunds by ! ,secret>y4 7ii7 ,provid] audits ,! ,secret>y %all conduct p]iodic audits ( claims submitt$ "u ?is "p ) respect to refundable s+le-dose conta9] or s+le-use package drugs 9 accordance ) ! au?ority "u section #ahcc7;e7 to ensure compliance ) ! requirem5ts applicable "u ?is subsection4 7,b7 ,civil money p5alty 7i7 ,9 g5]al ,! ,secret>y %all impose a civil money p5alty on a manufactur] ( a refundable s+le-dose conta9] or s+le-use package drug :o has fail$ to comply ) ! requirem5t "u p>agraph 7#b7 = su* drug = a cal5d> qu>t] 9 an am\nt equal to ! 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$+ "u section #aabh;,a7a74 7#g7 ,implem5tation ,! ,secret>y %all implem5t ?is subsection ?r\gh notice & comm5t rulemak+4 7#h7 ,def9ition ( refundable s+le-dose conta9] or s+le-use package drug 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 9 ?is subsection1 ! t]m refundable s+le-dose conta9] or s+le-use package drug means a s+le s\rce drug or biological 7z def9$ 9 section #ahdg;,a7c77#f77;,d77 or a biosimil> biological product 7z def9$ 9 section #ahdg;,a7c77#f77;,h77 = :i* paym5t is e/abli%$ "u ?is "p & t is furni%$ f a s+le-dose conta9] or s+le-use package4 7,b7 ,exclusions ,! t]m refundable s+le-dose conta9] or s+le-use package drug does n include a drug or biological t is ei!r a radioph>maceutical or an imag+ ag5t4 7#i7 ,report to ,congress 7,a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is subsection1 ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,food & ,drug ,adm9i/ration1 %all submit to ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives & ! ,committee on ,f9ance ( ! ,s5ate1 a report on any impact ?is subsection is demon/rat$ to h on-- 7i7 ! lic5sure1 m>ket entry1 m>ket ret5tion1 or m>ket+ ( biosimil> biological products2 & 7ii7 vial size *anges1 label adju/m5ts1 or te*nological developm5ts4 7,b7 ,updates ,at ! direction ( ! ,committees ref]r$ to 9 subp>agraph 7,a71 ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,food & ,drug ,adm9i/ration1 %all p]iodically update ! report "u su* subp>agraph4 4