,,ii #aaf? ,,congress #a/ ,session ,s4 #cgh ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,febru>y #g1 #bjai,mr4 ,br[n 7= himself1 ,mrs4 ,gillibr&1 & ,ms4 ,hassan7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d ! ,int]nal ,rev5ue ,code ( #aihf to e/abli% an excise tax on c]ta9 prescription drugs :i* h be5 subject to a price spike1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,/op ,price ,g\g+ ,act4 #b4 ,id5tification ( prescription drug price spikes 7a7 ,def9itions ,9 ?is section3 7#a7 ,applicable entity ,! t]m applicable entity means ! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or ( a lic5se issu$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 = a drug describ$ 9 p>agraph 7#e77;,a74 7#b7 ,av]age manufactur] price ,! t]m av]age manufactur] price-- 7,a7 has ! same mean+ giv5 su* t]m "u section #aibg7k77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a772 or 7,b7 ) respect to a drug = :i* !re is no av]age manufactur] price z s def9$1 su* t]m %all mean ! :olesale acquisition co/ ( ! drug4 7#c7 ,comm]ce ,! t]m comm]ce has ! mean+ giv5 su* t]m 9 section #d ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd74 7#d7 ,inspector ,g5]al ,! t]m ,inspector ,g5]al means ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#e7 ,prescription drug 7,a7 ,9 g5]al ,! t]m prescription drug means any drug 7z def9$ 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g7771 includ+ a comb9ation product ^: prim>y mode ( action is det]m9$ "u section #ejc7;g7 ( su* ,act 7#ba ,u4,s4,c4 #cec7;g77 to be t ( a drug1 & t-- 7i7 is subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#a772 & 7ii7 is cov]$ by a ,f$]al heal? c>e program 7z def9$ 9 section #aabh;,b7f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f7774 7,b7 ,treatm5t ( re=mulat$ drugs ,= purposes ( ?is section1 a prescription drug ) respect to :i* ! ,secret>y ( ,heal? & ,human ,s]vices has approv$ any m9or re=mulation t does n produce a mean+ful !rapeutic b5efit1 ! drug t 0 approv$ prior to any su* re=mulation & ! drug ) any su* re=mulation %all be consid]$ "o prescription drug4 7#f7 ,price spike 7,a7 ,9 g5]al ,! t]m price spike means an increase 9 ! av]age manufactur] price 9 comm]ce ( a prescription drug = :i* ! price spike p]c5tage is equal to or great] ?an applicable price increase all[ance4 7,b7 ,price spike p]c5tage ,! price spike p]c5tage is ! p]c5tage 7if any7 by :i*-- 7i7 ! av]age manufactur] price ( a prescription drug 9 comm]ce = ! cal5d> ye>2 exce$s 7ii7 ! av]age manufactur] price ( su* prescription drug 9 comm]ce = ! cal5d> ye> prec$+ su* ye>4 7,c7 ,applicable price increase all[ance ,! applicable price increase all[ance = any cal5d> ye> is ! p]c5tage 7r\nd$ to ! ne>e/ "o-t5? ( #a p]c5t7 by :i* ! ,c-,,cpi-,u 7z def9$ 9 section #a7;f77#f7 ( ! ,int]nal ,rev5ue ,code ( #aihf7 = t ye> exce$s ! ,c-,,cpi-,u = ! prec$+ cal5d> ye>4 7#g7 ,price spike rev5ue 7,a7 ,9 g5]al ,! price spike rev5ue = any cal5d> ye> is an am\nt equal to-- 7i7 ! gross price spike rev5ue1 m9us 7ii7 ! adju/m5t am\nt4 7,b7 ,gross price spike rev5ue ,! gross price spike rev5ue = any cal5d> ye> is an am\nt equal to ! product (-- 7i7 an am\nt equal to ! diff]5ce betwe5 clause 7i7 ( p>agraph 7#f77;,b7 & clause 7ii7 ( su* p>agraph2 & 7ii7 ! total numb] ( units ( ! prescription drug :i* 7 sold 9 comm]ce 9 su* cal5d> ye>4 7,c7 ,adju/m5t am\nt ,! adju/m5t am\nt is ! am\nt1 if any1 ( ! gross price spike rev5ue :i* ! ,inspector ,g5]al has det]m9$ is due solely to an increase 9 ! co/ ( ! inputs necess>y to manufacture ! prescription drug subject to ! price spike4 7b7 ,submission by ph>maceutical companies ( in=mation to ,inspector ,g5]al 7#a7 ,9 g5]al ,= ea* prescription drug1 ! applicable entity %all submit to ! ,inspector ,g5]al a qu>t]ly report t includes ! foll[+3 7,a7 ,= ea* prescription drug ( ! applicable entity-- 7i7 ! total numb] ( units ( ! prescription drug :i* 7 sold 9 comm]ce 9 ! prec$+ cal5d> qu>t]2 7ii7 ! av]age & m$ian price p] unit ( su* prescription drug 9 comm]ce 9 ! prec$+ cal5d> qu>t]1 disaggregated by mon?2 & 7iii7 ! gross rev5ues f sales ( su* prescription drug 9 comm]ce 9 ! prec$+ cal5d> qu>t]4 7,b7 ,su* in=mation relat$ to increas$ input co/s or public heal? consid]ations z ! applicable entity may wi% ! ,inspector ,g5]al to consid] 9 mak+ a det]m9ation "u clause 7ii7 ( subsection 7c77#b77;,b7 or an assessm5t 9 clause 7iii7 ( su* subsection = ! prec$+ cal5d> qu>t]4 7,c7 ,su* in=mation relat$ to any anticipat$ increas$ input co/s = ! subsequ5t cal5d> qu>t] z ! applicable entity may wi% ! ,inspector ,g5]al to consid] 9 mak+ a det]m9ation "u clause 7ii7 ( subsection 7c77#b77;,b7 or an assessm5t 9 clause 7iii7 ( su* subsection = su* cal5d> qu>t]4 7#b7 ,p5alty = failure to submit 7,a7 ,9 g5]al ,an applicable entity describ$ 9 p>agraph 7#a7 t fails to submit in=mation to ! ,inspector ,g5]al reg>d+ a prescription drug1 z requir$ by su* p>agraph1 be=e ! date specifi$ 9 p>agraph 7#c7 %all be liable = a civil p5alty1 z det]m9$ "u subp>agraph 7,b74 7,b7 ,am\nt ( p5alty ,! am\nt ( ! civil p5alty %all be equal to ! product (-- 7i7 an am\nt1 z det]m9$ appropriate by ! ,inspector ,g5]al1 :i* is-- 7,i7 n less ?an #j4e p]c5t ( ! gross rev5ues f sales ( ! prescription drug describ$ 9 subp>agraph 7,a7 = ! prec$+ cal5d> ye>1 & 7,,ii7 n great] ?an #a p]c5t ( ! gross rev5ues f sales ( su* prescription drug = ! prec$+ cal5d> ye>1 & 7ii7 ! numb] ( days 9 ! p]iod betwe5-- 7,i7 ! applicable date specifi$ 9 p>agraph 7#c71 & 7,,ii7 ! date on :i* ! ,inspector ,g5]al receives ! in=mation describ$ 9 p>agraph 7#a7 f ! applicable entity4 7#c7 ,submission deadl9e ,an applicable entity %all submit ea* qu>t]ly report describ$ 9 p>agraph 7#a7 n lat] ?an ,janu>y #ag1 ,april #ah1 ,june #ae1 & ,septemb] #ae ( ea* cal5d> ye>4 7c7 ,assessm5t by ,inspector ,g5]al 7#a7 ,9 g5]al ,n lat] ?an ! la/ day 9 ,febru>y ( ea* ye>1 ! ,inspector ,g5]al1 9 consultation ) o!r relevant ,f$]al ag5cies 7includ+ ! ,f$]al ,trade ,commission71 %all-- 7,a7 complete an assessm5t ( ! in=mation ! ,inspector ,g5]al receiv$ pursuant to subsection 7b77#a7 ) respect to sales ( prescription drugs 9 ! prec$+ cal5d> ye>2 & 7,b7 9 ! case ( any prescription drug :i* satisfies ! conditions describ$ 9 p>agraph 7#a7 or 7#b7 ( subsection 7d71 submit a recomm5dation to ! ,secret>y ( ,heal? & ,human ,s]vices t su* drug be exempt$ f application ( ! tax impos$ "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf 7z add$ by section #c ( ?is ,act7 = su* ye>4 7#b7 ,elem5ts ,! assessm5t requir$ by p>agraph 7#a77;,a7 %all include ! foll[+3 7,a7 ,id5tification ( ea* price spike relat+ to a prescription drug 9 ! prec$+ cal5d> ye>4 7,b7 ,= ea* price spike id5tifi$ "u subp>agraph 7,a7-- 7i7 a det]m9ation ( ! price spike rev5ue2 7ii7 a det]m9ation reg>d+ ! accuracy ( ! in=mation submitt$ by ! applicable entity reg>d+ increas$ input co/s2 & 7iii7 an assessm5t ( ! rationale ( ! applicable entity = ! price spike4 7d7 ,exemption ( c]ta9 drugs 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 ^u recomm5dation ( ! ,inspector ,g5]al pursuant to subsection 7c77#a77;,b71 may exempt any prescription drug :i* has be5 subject to a price spike dur+ ! prec$+ cal5d> ye> f application ( ! tax impos$ "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf = su* ye>1 if ! ,secret>y det]m9es t-- 7,a7 bas$ on in=mation submitt$ pursuant to subsection 7b77#a77;,b71 a =-cause price increase exemption %\ld apply2 or 7,b7 7i7 ! prescription drug :i* has be5 subject to a price spike has an av]age manufactur] price ( n great] ?an #aj = a #cj day supply2 & 7ii7 su* drug is m>ket$ by n less ?an #c o!r hold]s ( applications approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 :]e su* applications approv$ "u su* subsection 7j7 use z a ref]5ce drug ! drug s approv$ "u su* subsection 7c74 7#b7 ,cl>ification ,9 consid]+1 "u p>agraph 7#a77;,a71 in=mation submitt$ pursuant to subsection 7b77#a77;,b71 ! ,secret>y-- 7,a7 has ! discretion to det]m9e t su* in=mation does n w>rant a =-cause price increase exemption2 & 7,b7 %all exclude f su* consid]ation any in=mation submitt$ by ! applicable entity ?reat5+ to curtail or limit production ( ! prescription drug if ! ,secret>y does n grant an exemption f ! application ( ! tax "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf4 7e7 ,inspector ,g5]al report to ,int]nal ,rev5ue ,s]vice 7#a7 ,9 g5]al ,subject to p>agraph 7#c71 n lat] ?an ! la/ day 9 ,febru>y ( ea* ye>1 ! ,inspector ,g5]al %all transmit to ! ,int]nal ,rev5ue ,s]vice a report on ! f9d+s ( ! ,inspector ,g5]al ) respect to ! in=mation ! ,inspector ,g5]al receiv$ "u subsection 7b77#a7 ) respect to ! prec$+ cal5d> ye> & ! assessm5t c>ri$ out by ! ,inspector ,g5]al "u subsection 7c77#a77;,a7 ) respect to su* in=mation4 7#b7 ,cont5ts ,! report transmitt$ "u p>agraph 7#a7 %all include ! foll[+3 7,a7 ,! in=mation receiv$ "u subsection 7b77#a7 ) respect to ! prec$+ cal5d> ye>4 7,b7 ,! price spikes id5tifi$ "u subp>agraph 7,a7 ( subsection 7c77#b74 7,c7 ,! price spike rev5ue det]m9ations made "u subp>agraph 7,b77i7 ( su* subsection4 7,d7 ,! det]m9ations & assessm5ts made "u clauses 7ii7 & 7iii7 ( subp>agraph 7,b7 ( su* subsection4 7#c7 ,notice & opportunity = he>+ 7,a7 ,9 g5]al ,no report %all be transmitt$ to ! ,int]nal ,rev5ue ,s]vice "u p>agraph 7#a7 9 reg>ds to a prescription drug unless ! ,inspector ,g5]al has provid$ ! applicable entity )-- 7i7 ! assessm5t ( su* drug "u subsection 7c77#a77;,a72 & 7ii7 notice ( _! "r to a he>+ 9 reg>ds to su* assessm5t4 7,b7 ,notice ,! notice requir$ "u subp>agraph 7,a7 %all be provid$ to ! applicable entity n lat] ?an #cj days aft] completion ( ! assessm5t "u subsection 7c77#a77;,a74 7,c7 ,reque/ = he>+ ,subject to subp>agraph 7,e71 an applicable entity may reque/ a he>+ be=e ! ,secret>y ( ,heal? & ,human ,s]vices n lat] ?an #cj days aft] ! date on :i* ! notice "u subp>agraph 7,b7 is receiv$4 7,d7 ,completion ( he>+ ,9 ! case ( an applicable entity :i* reque/s a he>+ pursuant to subp>agraph 7,c71 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 n lat] ?an #ab mon?s aft] ! date on :i* ! assessm5t "u subsection 7c77#a77;,a7 0 complet$ by ! ,inspector ,g5]al-- 7i7 make a f9al det]m9ation 9 reg>ds ! accuracy ( su* assessm5t2 & 7ii7 provide ! report describ$ 9 p>agraph 7#b7 to ! ,int]nal ,rev5ue ,s]vice4 7,e7 ,limitation ,an applicable entity may reque/ a he>+ "u subp>agraph 7,c7 ) respect to a p>ticul> prescription drug only once )9 a #e-ye> p]iod4 7#d7 ,publication 7,a7 ,9 g5]al ,n lat] ?an ! la/ day 9 ,febru>y ( ea* ye>1 subject to subp>agraph 7,b71 ! ,inspector ,g5]al %all make ! report transmitt$ "u p>agraph 7#a7 available to ! public1 includ+ on ! ,int]net website ( ! ,inspector ,g5]al1 subject to subp>agraph 7,b74 7,b7 ,propriet>y in=mation ,! ,inspector ,g5]al %all ensure t any in=mation made public 9 accordance ) subp>agraph 7,a7 excludes trade secrets & confid5tial comm]cial in=mation4 7f7 ,notification ,! ,secret>y ( ! ,treasury1 9 conjunction ) ! ,inspector ,g5]al1 %all notify1 at su* "t & 9 su* mann] z ! ,secret>y ( ! ,treasury %all provide1 ea* applicable entity 9 reg>d to any prescription drug :i* has be5 det]m9$ to h be5 subject to a price spike dur+ ! prec$+ cal5d> ye> & ! am\nt ( ! tax impos$ on su* applicable entity pursuant to section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf4 #c4 ,excise tax on prescription drugs subject to price spikes 7a7 ,9 g5]al ,sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #daib4 ,prescription drugs subject to price spikes 7a7 ,imposition ( tax 7#a7 ,9 g5]al ,subject to p>agraph 7#c71 = ea* taxable prescription drug sold by an applicable entity dur+ ! cal5d> ye>1 !re is h]eby impos$ on su* entity a tax equal to ! great] (-- 7,a7 ! annual price spike tax = su* prescription drug1 or 7,b7 subject to p>agraph 7#b71 ! cumulative price spike tax = su* prescription drug4 7#b7 ,limitation ,9 ! case ( a taxable prescription drug = :i* ! applicable p]iod 7z det]m9$ "u subsection 7c77#b77;,e77i77 is less ?an #b cal5d> ye>s1 ! cumulative price spike tax %all n apply4 7#c7 ,exemption ,= any cal5d> ye> 9 :i* ! ,secret>y ( ,heal? & ,human ,s]vices has provid$ an exemption = a taxable prescription drug pursuant to section #b7;d7 ( ! ,/op ,price ,g\g+ ,act1 ! am\nt ( ! tax det]m9$ "u p>agraph 7#a7 = su* drug or device = su* cal5d> ye> %all be r$uc$ to z]o4 7b7 ,annual price spike tax 7#a7 ,9 g5]al ,! am\nt ( ! annual price spike tax %all be equal to ! applicable p]c5tage ( ! price spike rev5ue receiv$ by ! applicable entity on ! sale ( ! taxable prescription drug dur+ ! cal5d> ye>4 7#b7 ,applicable p]c5tage ,= purposes ( p>agraph 7#a71 ! applicable p]c5tage %all be equal to-- 7,a7 9 ! case ( a taxable prescription drug :i* has be5 subject to a price spike p]c5tage great] ?an ! applicable price increase all[ance 7z def9$ 9 section #b7;a77#f77;,c7 ( ! ,/op ,price ,g\g+ ,act7 b less ?an #ae p]c5t1 #ej p]c5t1 7,b7 9 ! case ( a taxable prescription drug :i* has be5 subject to a price spike p]c5tage equal to or great] ?an #ae p]c5t b less ?an #bj p]c5t1 #ge p]c5t1 & 7,c7 9 ! case ( a taxable prescription drug :i* has be5 subject to a price spike p]c5tage equal to or great] ?an #bj p]c5t1 #ajj p]c5t4 7c7 ,cumulative price spike tax 7#a7 ,9 g5]al ,! am\nt ( ! cumulative price spike tax %all be equal to ! applicable p]c5tage ( ! cumulative price spike rev5ue receiv$ by ! applicable entity on ! sale ( ! taxable prescription drug dur+ ! cal5d> ye>4 7#b7 ,applicable p]c5tage 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 ! applicable p]c5tage %all be equal to-- 7i7 9 ! case ( a taxable prescription drug :i* has be5 subject to a cumulative price spike p]c5tage great] ?an ! cumulative price increase all[ance b less ?an ! fir/ multi-ye> p]c5tage1 #ej p]c5t1 7ii7 9 ! case ( a taxable prescription drug :i* has be5 subject to a cumulative price spike p]c5tage equal to or great] ?an ! fir/ multi-ye> p]c5tage b less ?an ! second multi-ye> p]c5tage1 #ge p]c5t1 & 7iii7 9 ! case ( a taxable prescription drug :i* has be5 subject to a cumulative price spike p]c5tage equal to or great] ?an ! second multi-ye> p]c5tage1 #ajj p]c5t4 7,b7 ,cumulative price spike p]c5tage ,! cumulative price spike p]c5tage is ! p]c5tage 7if any7 by :i*-- 7i7 ! av]age manufactur] price ( ! taxable prescription drug 9 comm]ce = ! prec$+ cal5d> ye>1 exce$s 7ii7 ! av]age manufactur] price ( su* prescription drug 9 comm]ce = ! base ye>4 7,c7 ,cumulative price increase all[ance ,= purposes ( clause 7i7 ( subp>agraph 7,a71 ! cumulative price increase all[ance = any cal5d> ye> is ! p]c5tage 7r\nd$ to ! ne>e/ "o-t5? ( #a p]c5t7 by :i* ! ,c-,,cpi-,u 7z def9$ 9 section #a7;f77#f77 = t ye> exce$s ! ,c-,,cpi-,u = ! base ye>4 7,d7 ,multi-ye> p]c5tages ,= purposes ( subp>agraph 7,a71 ! fir/ multi-ye> p]c5tage & second multi-ye> p]c5tage %all be det]m9$ 9 accordance ) ! foll[+ table3 ,numb] ( ye>s 9 applicable period,first multi-ye> percentage,second multi-ye> p]c5tage#b ye>s#ag4ebb4ec ye>s#bj4jbe4jd ye>s#bb4ebg4ee ye>s#be4jcj4j4 7,e7 ,applicable p]iod & base ye> 7i7 ,applicable p]iod ,! applicable p]iod %all be ! less] (-- 7,i7 ! #e prec$+ cal5d> ye>s1 7,,ii7 all cal5d> ye>s beg9n+ aft] ! date ( enactm5t ( ?is section1 or 7,,iii7 all cal5d> ye>s 9 :i* ! taxable prescription drug 0 sold 9 comm]ce4 7ii7 ,base ye> ,! base ye> %all be ! cal5d> ye> imm$iately prec$+ ! applicable p]iod4 7#c7 ,cumulative price spike rev5ue ,= purposes ( p>agraph 7#a71 ! cumulative price spike rev5ue = any taxable prescription drug %all be an am\nt equal to-- 7,a7 an am\nt equal to ! product (-- 7i7 an am\nt 7n less ?an z]o7 equal to-- 7,i7 ! av]age manufactur] price ( su* prescription drug 9 comm]ce = ! prec$+ cal5d> ye>1 m9us 7,,ii7 ! av]age manufactur] price ( su* prescription drug 9 comm]ce = ! base ye>1 & 7ii7 ! total numb] ( units ( su* prescription drug :i* 7 sold 9 comm]ce 9 ! prec$+ cal5d> ye>1 m9us 7,b7 an am\nt equal to ! sum ( ! adju/m5t am\nts1 if any1 det]m9$ "u section #b7;a77#g77;,c7 ( ! ,/op ,price ,g\g+ ,act = ea* cal5d> ye> dur+ ! applicable p]iod4 7d7 ,def9itions ,= purposes ( ?is section-- 7#a7 ,taxable prescription drug ,! t]m taxable prescription drug means a prescription drug 7z def9$ 9 section #b7;a77#e7 ( ! ,/op ,price ,g\g+ ,act7 :i* has be5 id5tifi$ by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 "u section #b7;c77#b77;,a7 ( su* ,act1 z be+ subject to a price spike4 7#b7 ,o!r t]ms ,! t]ms applicable entity1 av]age manufactur] price1 price spike1 price spike p]c5tage1 & price spike rev5ue h ! same mean+ giv5 su* t]ms "u section #b7;a7 ( ! ,/op ,price ,g\g+ ,act4 4 7b7 ,cl]ical am5dm5ts 7#a7 ,! head+ ( sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ ,m$ical devices & ins]t+ ,c]ta9 m$ical devices & prescription drugs4 7#b7 ,! table ( sub*apt]s = *apt] #cb ( su* ,code is am5d$ by /rik+ ! item relat+ to sub*apt] ,e & ins]t+ ! foll[+ new item3 ,sub*apt] ,e4 ,c]ta9 m$ical devices & prescription drugs 4 7#c7 ,! table ( sections = sub*apt] ,e ( *apt] #cb ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #daib4 ,prescription drugs subject to price spikes4 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to sales aft] ! date ( ! enactm5t ( ?is ,act4 #d4 ,/udy on monopoly m$ical products 7a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy t exam9es-- 7#a7 h[ drug manufactur]s & heal? plans 7includ+ private insur]s1 ! ,m$ic>e program1 & ,/ate ,m$icaid programs7 e/abli% initial laun* prices = newly approv$ drugs2 & 7#b7 alt]native me?ods t h be5 propos$ = sett+ ! price ( new drugs4 7b7 ,/udy ( specific drugs ,z "p ( ! /udy describ$ 9 subsection 7a71 ! ,comptroll] ,g5]al %all exam9e drug pric+ ) respect to sev]al drugs approv$ )9 ! #e-ye> p]iod imm$iately prec$+ ! date ( enactm5t ( ?is ,act & explore pot5tial alt]native approa*es to e/abli% new drug prices t c\ld help make new drugs m af=dable1 bett] reflect ! cl9ical value ( su* drugs 9 treat+ pati5ts1 & ma9ta9 inc5tives = innovation4 7c7 ,factors ,9 conduct+ ! /udy describ$ 9 subsection 7a71 ! ,comptroll] ,g5]al %all consid]-- 7#a7 :at factors drug manufactur]s & heal? plans consid] 9 e/abli%+ initial laun* prices2 7#b7 h[ initial pric+ decisions by drug manufactur]s & heal? plans affect co/s & use ( s]vices = pati5ts & public programs su* z ! ,m$ic>e & ,m$icaid programs2 7#c7 ef=ts by heal? plans to limit co/s1 includ+ ?r\gh b5efit design or cov]age limitations2 7#d7 h[ prices *ange 9 ! fir/ few ye>s foll[+ a new drug's laun*2 & 7#e7 recomm5dations manufactur]s1 heal? plans1 & o!r exp]ts h = alt]native approa*es to e/abli%+ new drug prices & ! b5efits & *all5ges associat$ ) su* alt]native approa*es4 #e4 ,rev5ues collect$ ,!re are au?oriz$ to be appropriat$ to ! ,secret>y ( ,heal? & ,human ,s]vices su* sums z are equal to any increase 9 rev5ue to ! ,treasury by reason ( ! provisions ( ?is ,act or ! am5dm5ts made by ?is ,act = ! purposes ( increas+ am\nts available to ! ,national ,in/itutes ( ,heal? = rese>* & developm5t ( drugs4