,,ib ,union ,cal5d> ,no4 #agj #aaf? ,,congress #a/ ,session ,h4 ,r4 #bbif ,report ,no4 #aaf-bae ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #ab1 #bjai ,ms4 ,s*ak[sky 7= h]self & ,mr4 ,rooney ( ,florida7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,septemb] #bd1 #bjai;,additional sponsors3 ,mr4 ,doggett1 ,mr4 ,s>banes1 ,ms4 ,und]wood1 ,mr4 ,griffi?1 ,mr4 ,suozzi1 ,mr4 ,pocan1 & ,mr4 ,c>t] ( ,georgia ,septemb] #bd1 #bjai ,report$ ) am5dm5ts1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be pr9t$ ,/rike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,= text ( introduc$ bill1 see copy ( bill z introduc$ on ,april #ab1 #bjai ,a ,,bill ,to require report+ reg>d+ c]ta9 drug price increases1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,m ,effici5t ,tools to ,realize ,in=mation = ,consum]s ,act or ! ,,metric ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,sec4 #b4 ,report+ on explanation = drug price increases4 ,sec4 #c4 ,public disclosure ( drug disc\nts4 ,sec4 #d4 ,/udy ( ph>maceutical supply *a9 int]m$i>ies & m]g] activity4 ,sec4 #e4 ,requir+ c]ta9 manufactur]s to report drug pric+ in=mation ) respect to drugs "u ! ,m$ic>e program4 ,sec4 #f4 ,mak+ prescription drug m>ket+ sample in=mation report$ by manufactur]s available to c]ta9 individuals & entities4 ,sec4 #g4 ,requir+ prescription drug plan sponsors to include real-"t b5efit in=mation z "p ( su* sponsor's electronic prescription program "u ! ,m$ic>e program4 ,sec4 #h4 ,s5se ( ,congress reg>d+ ! ne$ to exp& comm]cially available drug pric+ comp>ison plat=ms4 ,sec4 #i4 ,te*nical corrections4 #b4 ,report+ on explanation = drug price increases 7a7 ,9 g5]al ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by add+ at ! end ! foll[+3 ,w ,drug ,price ,report+2 ,drug ,value ,fund #cii,,oo4 ,report+ on explanation = drug price increases 7a7 ,def9itions ,9 ?is section3 7#a7 ,manufactur] ,! t]m manufactur] means ! p]son-- 7,a7 t holds ! application = a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ?is ,act2 or 7,b7 :o is responsible = sett+ ! :olesale acquisition co/ = ! drug4 7#b7 ,qualify+ drug ,! t]m qualify+ drug means any drug t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ?is ,act-- 7,a7 t has a :olesale acquisition co/ ( #ajj or m1 adju/$ = inflation occurr+ aft] ! date ( enactm5t ( ! ,m ,effici5t ,tools to ,realize ,in=mation = ,consum]s ,act1 = a mon?'s supply or a typical c\rse ( treatm5t t la/s less ?an a mon?1 & is-- 7i7 subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7ii7 adm9i/]$ or o!rwise disp5s$ to treat a disease or condition affect+ m ?an #bjj1jjj p]sons 9 ! ,unit$ ,/ates2 & 7iii7 n a vacc9e2 & 7,b7 = :i*1 dur+ ! previ\s cal5d> ye>1 at lea/ #a doll> ( ! total am\nt ( sales 7 = individuals enroll$ "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or "u a ,/ate ,m$icaid plan "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq47 or "u a waiv] ( su* plan4 7#c7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,report requir$ ,! manufactur] ( a qualify+ drug %all submit a report to ! ,secret>y = ea* increase 9 ! price ( a qualify+ drug t results 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7,a7 #aj p]c5t or m )9 a s+le cal5d> ye> beg9n+ on or aft] ,janu>y #a1 #bjai2 or 7,b7 #be p]c5t or m )9 ?ree consecutive cal5d> ye>s = :i* ! fir/ su* cal5d> ye> beg9s on or aft] ,janu>y #a1 #bjai4 7#b7 ,report deadl9e ,ea* report describ$ 9 p>agraph 7#a7 %all be submitt$ to ! ,secret>y-- 7,a7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs dur+ ! p]iod beg9n+ on ,janu>y #a1 #bjai1 & end+ on ! day t is #fj days aft] ! date ( ! enactm5t ( ! ,m ,effici5t ,tools to ,realize ,in=mation = ,consum]s ,act1 n lat] ?an #ij days aft] su* date ( enactm5t2 & 7,b7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs aft] ! p]iod describ$ 9 subp>agraph 7,a71 n lat] ?an #cj days prior to ! plann$ effective date ( su* price increase = su* qualify+ drug4 7c7 ,cont5ts ,a report "u subsection 7b71 consi/5t ) ! /&>d = disclosures describ$ 9 section #bac4c7;d7 ( title #ab1 ,code ( ,f$]al ,regulations 7z 9 effect on ! date ( enactm5t ( ! ,m ,effici5t ,tools to ,realize ,in=mation = ,consum]s ,act71 %all1 at a m9imum1 include-- 7#a7 ) respect to ! qualify+ drug-- 7,a7 ! p]c5tage by :i* ! manufactur] w raise ! :olesale acquisition co/ ( ! drug )9 ! cal5d> ye> or ?ree consecutive cal5d> ye>s z describ$ 9 subsection 7b77#a77;,a7 or 7b77#a77;,b71 & ! effective date ( su* price increase2 7,b7 an explanation =1 & description (1 ea* price increase = su* drug t w occur dur+ ! cal5d> ye> p]iod describ$ 9 subsection 7b77#a77;,a7 or ! ?ree consecutive cal5d> ye> p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable2 7,c7 if kn[n & diff]5t f ! manufactur] ( ! qualify+ drug1 ! id5tity (-- 7i7 ! sponsor or sponsors ( any inve/igational new drug applications "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = cl9ical inve/igations ) respect to su* drug1 = :i* ! full reports are submitt$ z "p ( ! application-- 7,i7 = approval ( ! drug "u section #eje ( su* ,act2 or 7,,ii7 = lic5sure ( ! drug "u section #cea ( ?is ,act2 & 7ii7 ! sponsor ( an application = ! drug approv$ "u su* section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ?is ,act2 7,d7 a description ( ! hi/ory ( ! manufactur]'s price increases = ! drug s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea ( ?is ,act1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se1 if applicable2 7,e7 ! curr5t :olesale acquisition co/ ( ! drug2 7,f7 ! total exp5ditures ( ! manufactur] on-- 7i7 mat]ials & manufactur+ = su* drug2 & 7ii7 acquir+ pat5ts & lic5s+ = su* drug2 7,g7 ! p]c5tage ( total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t 0 d]iv$ f ,f$]al funds2 7,h7 ! total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t is necess>y to demon/rate t x meets applicable /atutory /&>ds = approval "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u section #cea ( ?is ,act1 z applicable2 7,i7 ! total exp5ditures ( ! manufactur] on pursu+ new or exp&$ indications or dosage *anges = su* drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ?is ,act2 7,j7 ! total exp5ditures ( ! manufactur] on c>ry+ out po/m>ket requirem5ts relat$ to su* drug1 includ+ "u section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7,k7 ! total rev5ue & ! net pr(it g5]at$ f ! qualify+ drug = ea* cal5d> ye> s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se2 & 7,l7 ! total co/s associat$ ) m>ket+ & adv]tis+ = ! qualify+ drug2 7#b7 ) respect to ! manufactur]-- 7,a7 ! total rev5ue & ! net pr(it ( ! manufactur] = ea* ( ! #a-ye> p]iod describ$ 9 subsection 7b77#a77;,a7 or ! #c-ye> p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable2 7,b7 all /ock-bas$ p]=mance metrics us$ by ! manufactur] to det]m9e executive comp5sation = ea* ( ! #a-ye> p]iod describ$ 9 subsection 7b77#a77;,a7 or ! #c-ye> p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable2 & 7,c7 any additional in=mation ! manufactur] *ooses to provide relat$ to drug pric+ decisions1 su* z total exp5ditures on-- 7i7 drug rese>* & developm5t2 or 7ii7 cl9ical trials1 includ+ on drugs t fail$ to receive approval by ! ,food & ,drug ,adm9i/ration2 & 7#c7 su* o!r relat$ in=mation z ! ,secret>y consid]s appropriate & z specifi$ by ! ,secret>y ?r\gh notice-&-comm5t rulemak+4 7d7 ,in=mation provid$ ,! manufactur] ( a qualify+ drug t is requir$ to submit a report "u subsection 7b71 %all ensure t su* report & any explanation =1 & description (1 ea* price increase describ$ 9 subsection 7c77#a77;,b7 %all be tru?ful1 n mislead+1 & accurate4 7e7 ,civil monet>y p5alty ,any manufactur] ( a qualify+ drug t fails to submit a report = ! drug z requir$ by ?is section1 foll[+ notification by ! ,secret>y to ! manufactur] t ! manufactur] is n 9 compliance ) ?is section1 %all be subject to a civil monet>y p5alty ( #ge1jjj = ea* day on :i* ! violation cont9ues4 7f7 ,false in=mation ,any manufactur] t submits a report = a drug z requir$ by ?is section t kn[+ly provides false in=mation 9 su* report is subject to a civil monet>y p5alty 9 an am\nt n to exce$ #ge1jjj = ea* item ( false in=mation4 7g7 ,public po/+ 7#a7 ,9 g5]al ,subject to p>agraph 7#c71 ! ,secret>y %all po/ ea* report submitt$ "u subsection 7b7 on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ! day ! price increase ( a qualify+ drug is s*$ul$ to g into effect4 7#b7 ,=mat ,9 develop+ ! =mat 9 :i* reports w be publicly po/$ "u p>agraph 7#a71 ! ,secret>y %all consult ) /akehold]s1 includ+ b5efici>y gr\ps1 & %all seek fe$back f consum] advocates & readability exp]ts on ! =mat & pres5tation ( ! cont5t ( su* reports to ensure t su* reports are-- 7,a7 us]-fri5dly to ! public2 & 7,b7 writt5 9 pla9 language t consum]s c readily und]/&4 7#c7 ,protect$ in=mation ,no?+ 9 ?is section %all be con/ru$ to au?orize ! public disclosure ( in=mation submitt$ by a manufactur] t is prohibit$ f disclosure by applicable laws conc]n+ ! protection ( trade secrets1 comm]cial in=mation1 & o!r in=mation cov]$ "u su* laws4 #cii,,oo-#a4 ,annual report to ,congress 7a7 ,9 ,g5]al ,subject to subsection 7b71 ! ,secret>y %all submit to ,congress1 & po/ on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 a way t is us]-fri5dly to ! public & writt5 9 pla9 language t consum]s c readily und]/&1 an annual report-- 7#a7 summ>iz+ ! in=mation report$ pursuant to section #cii,,oo2 7#b7 includ+ copies ( ! reports & support+ detail$ economic analyses submitt$ pursuant to su* section2 7#c7 detail+ ! co/s & exp5ditures incurr$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 c>ry+ out section #cii,,oo2 & 7#d7 expla9+ h[ ! ,dep>tm5t ( ,heal? & ,human ,s]vices is improv+ consum] & provid] in=mation ab\t drug value & drug price transp>5cy4 7b7 ,protect$ in=mation ,no?+ 9 ?is section %all be con/ru$ to au?orize ! public disclosure ( in=mation submitt$ by a manufactur] t is prohibit$ f disclosure by applicable laws conc]n+ ! protection ( trade secrets1 comm]cial in=mation1 & o!r in=mation cov]$ "u su* laws4 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 takes effect on ! date ( enactm5t ( ?is ,act4 #c4 ,public disclosure ( drug disc\nts ,section #aaej;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#bc7 is am5d$-- 7#a7 9 subsection 7c71 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ 7o!r ?an z p]mitt$ "u subsection 7e77 aft] disclos$ by ! ,secret>y2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7e7 ,public availability ( c]ta9 in=mation 7#a7 ,9 g5]al ,9 ord] to all[ ! comp>ison ( ,p,b,ms' ability to negotiate rebates1 disc\nts1 direct & indirect remun]ation fees1 adm9i/rative fees1 & price concessions & ! am\nt ( su* rebates1 disc\nts1 direct & indirect remun]ation fees1 adm9i/rative fees1 & price concessions t are pass$ ?r\gh to plan sponsors1 beg9n+ ,janu>y #a1 #bjbj1 ! ,secret>y %all make available on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ! in=mation ) respect to ! second prec$+ cal5d> ye> provid$ to ! ,secret>y on g5]ic disp5s+ rates 7z describ$ 9 p>agraph 7#a7 ( subsection 7b77 & in=mation provid$ to ! ,secret>y "u p>agraphs 7#b7 & 7#c7 ( su* subsection t1 z det]m9$ by ! ,secret>y1 is ) respect to ea* ,,pbm4 7#b7 ,availability ( data ,9 c>ry+ out p>agraph 7#a71 ! ,secret>y %all ensure ! foll[+3 7,a7 ,confid5tiality ,! in=mation describ$ 9 su* p>agraph is display$ 9 a mann] t prev5ts ! disclosure ( in=mation1 ) respect to an individual drug or an individual plan1 on rebates1 disc\nts1 direct & indirect remun]ation fees1 adm9i/rative fees1 & price concessions4 7,b7 ,class ( drug ,! in=mation describ$ 9 su* p>agraph is made available by class ( drug1 us+ an exi/+ classification sy/em1 b only if ! class conta9s su* numb] ( drugs1 z specifi$ by ! ,secret>y 7b n few] ?an ?ree drugs71 to ensure confid5tiality ( propriet>y in=mation or o!r in=mation t is prev5t$ to be disclos$ "u subp>agraph 7,a74 4 #d4 ,/udy ( ph>maceutical supply *a9 int]m$i>ies & m]g] activity 7a7 ,initial report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,commission %all submit to ! appropriate committees ( ,congress a report t-- 7#a7 addresses at m9imum-- 7,a7 :e!r ph>macy b5efit manag]s-- 7i7 *>ge pay]s a high] price ?an ! reimbursem5t rate at :i* ! ph>macy b5efit manag]s reimburse compet+ ph>macies2 7ii7 /e] pati5ts = anticompetitive purposes to any ph>macies1 includ+ retail1 mail-ord]1 or any o!r type ( ph>macy1 9 :i* ! ph>macy b5efit manag] has an own]%ip int]e/2 7iii7 audit or review propriet>y data1 includ+ acquisition co/s1 pati5t in=mation1 or disp5s+ in=mation1 ( compet+ ph>macies t c be us$ = anticompetitive purposes2 or 7iv7 use =mul>y designs to increase ! m>ket %>e ( high] co/ prescription drugs & depress ! m>ket %>e ( l[] co/ prescription drugs 7ea* net ( rebates & disc\nts72 7,b7 h[ companies & pay]s assess ! b5efits1 co/s1 & risks ( contract+ ) int]m$i>ies1 includ+ ph>macy s]vices adm9i/rative organizations1 & :e!r m in=mation ab\t ! roles ( int]m$i>ies %\ld be available to consum]s & pay]s2 & 7,c7 :e!r !re are any specific legal or regulatory ob/acles ! ,commission curr5tly faces 9 ensur+ a competitive & transp>5t m>ketplace 9 ! ph>maceutical supply *a91 includ+ ! ph>macy b5efit manag] m>ketplace & ph>macy s]vices adm9i/rative organizations2 & 7#b7 provides-- 7,a7 obs]vations or conclusions drawn f ! ,novemb] #bjag r\ndtable entitl$ ,und]/&+ ,competition 9 ,prescription ,drug ,m>kets3 ,entry & ,supply ,*a9 ,dynamics1 & any simil> ef=ts2 7,b7 specific actions ! ,commission int5ds to take z a result ( ! ,novemb] #bjag r\ndtable1 & any simil> ef=ts1 includ+ a detail$ description ( relevant =?com+ actions1 additional rese>* or r\ndtable discussions1 consum] education ef=ts1 or en=cem5t actions2 & 7,c7 policy or legislative recomm5dations to-- 7i7 improve transp>5cy & competition 9 ! ph>maceutical supply *a92 7ii7 prev5t & det] anticompetitive behavior 9 ! ph>maceutical supply *a92 & 7iii7 be/ ensure t consum]s b5efit f any co/ sav+s or effici5cies t may result f m]g]s & consolidations4 7b7 ,int]im report ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,commission %all submit to ! appropriate committees ( ,congress an int]im report on ! progress ( ! report requir$ by subsection 7a71 along ) prelim9>y f9d+s & conclusions bas$ on in=mation collect$ to t date4 7c7 ,def9itions ,9 ?is section3 7#a7 ,appropriate committees ( congress ,! t]m appropriate committees ( ,congress means-- 7,a7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7,b7 ! ,committee on ! ,judici>y ( ! ,s5ate2 & 7,c7 ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives4 7#b7 ,commission ,! t]m ,commission means ! ,f$]al ,trade ,commission4 #e4 ,requir+ c]ta9 manufactur]s to report drug pric+ in=mation ) respect to drugs "u ! ,m$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 ,if ! manufactur] ( a drug or biological describ$ 9 subp>agraph 7,c71 7,e71 or 7,g7 ( section #ahdb7o77#a7 or 9 section #ahha7;b77#ad77;,b7 t is payable "u ?is "p has n ent]$ into & does n h 9 effect a rebate agreem5t describ$ 9 subsection 7b7 ( 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* drug or biological 9 a "t & mann] specifi$ by ! ,secret>y4 ,= purposes ( apply+ ?is p>agraph1 a drug or biological describ$ 9 ! previ\s s5t5ce includes items1 s]vices1 supplies1 & products t are payable "u ?is "p z a drug or biological4 7,b7 ,audit ,in=mation report$ "u subp>agraph 7,a7 is subject to audit by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7,c7 ,v]ification ,! ,secret>y may survey :olesal]s & manufactur]s t directly di/ribute drugs describ$ 9 subp>agraph 7,a71 :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$+ "u section #aabh;,a7a74 7,d7 ,confid5tiality ,not)/&+ any o!r provision ( law1 in=mation disclos$ 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$ = drugs 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 ( ! ,unit$ ,/ates 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 a 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 ( a drug or biological f su* t]m44 7c7 ,manufactur]s ) a rebate agreem5t 7#a7 ,9 g5]al ,section #aibg7;b77#c77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,= purposes ( apply+ clause 7iii71 a drug or biological describ$ 9 ! flu% matt] foll[+ su* clause includes items1 s]vices1 supplies1 & products t are payable "u ?is "p z a drug or biological44 7#b7 ,te*nical am5dm5t ,section #aibg7;b77#c77;,a77iii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77iii77 is am5d$ by /rik+ section #ahha7;b77#ac77;,a77ii7 & ins]t+ section #ahha7;b77#ad77;,b74 7d7 ,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 #f4 ,mak+ prescription drug m>ket+ sample in=mation report$ by manufactur]s available to c]ta9 individuals & entities 7a7 ,9 g5]al ,section #aabh;,h ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;i7 is am5d$-- 7#a7 by r$esignat+ subsection 7b7 z subsection 7e72 & 7#b7 by ins]t+ aft] subsection 7a7 ! foll[+ new subsections3 7b7 ,data %>+ agreem5ts 7#a7 ,9 g5]al ,! ,secret>y %all ent] into agreem5ts ) ! specifi$ data %>+ individuals & entities describ$ 9 p>agraph 7#b7 "u :i*-- 7,a7 ^u reque/ ( su* an individual or entity1 z applicable1 ! ,secret>y makes available to su* individual or entity ! in=mation submitt$ "u subsection 7a7 by manufactur]s & au?oriz$ di/ributors ( record2 & 7,b7 su* individual or entity agrees to n disclose publicly or to ano!r individual or entity any in=mation t id5tifies a p>ticul> practition] or heal? c>e facility4 7#b7 ,specifi$ data %>+ individuals & entities ,= purposes ( p>agraph 7#a71 ! specifi$ data %>+ individuals & entities describ$ 9 ?is p>agraph are ! foll[+3 7,a7 ,ov]sight ag5cies ,heal? ov]sight ag5cies 7z def9$ 9 section #afd4eja ( title #de1 ,code ( ,f$]al ,regulations71 includ+ ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,gov]nm5t ,acc\ntability ,(fice1 ! ,congressional ,budget ,(fice1 ! ,m$ic>e ,paym5t ,advisory ,commission1 & ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission4 7,b7 ,rese>*]s ,individuals :o conduct sci5tific rese>* 7z def9$ 9 section #afd4eja ( title #de1 ,code ( ,f$]al ,regulations7 9 relevant areas z det]m9$ by ! ,secret>y4 7,c7 ,pay]s ,private & public heal? c>e pay]s1 includ+ gr\p heal? plans1 heal? insurance cov]age (f]$ by heal? insurance issu]s1 ,f$]al heal? programs1 & ,/ate heal? programs4 7#c7 ,exemption f ,fre$om ( ,in=mation ,act ,except z describ$ 9 p>agraph 7#a71 ! ,secret>y may n be compell$ to disclose ! in=mation submitt$ "u subsection 7a7 to any individual or entity4 ,= purposes ( section #eeb ( title #e1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,fre$om ( ,in=mation ,act71 ?is p>agraph %all be consid]$ a /atute describ$ 9 subsection 7b77#c77;,b7 ( su* section4 7c7 ,p5alties 7#a7 ,data %>+ agreem5ts ,subject to p>agraph 7#c71 any specifi$ data %>+ individual or entity describ$ 9 subsection 7b77#b7 t violates ! t]ms ( a data %>+ agreem5t ! individual or entity has ) ! ,secret>y "u subsection 7b77#a7 %all be subject to a civil money p5alty ( n less ?an #a1jjj1 b n m ?an #aj1jjj1 = ea* su* violation4 ,su* p5alty %all be impos$ & collect$ 9 ! same mann] z civil money p5alties "u subsection 7a7 ( section #aabh;,a are impos$ & collect$ "u t section4 7#b7 ,failure to report ,subject to p>agraph 7#c71 any manufactur] or au?oriz$ di/ributor ( record ( an applicable drug "u subsection 7a7 t fails to submit in=mation requir$ "u su* subsection 9 a timely mann] 9 accordance ) rules or regulations promulgat$ to c>ry out su* subsection %all be subject to a civil money p5alty ( n less ?an #a1jjj1 b n m ?an #aj1jjj1 = ea* su* failure4 ,su* p5alty %all be impos$ & collect$ 9 ! same mann] z civil money p5alties "u subsection 7a7 ( section #aabh;,a are impos$ & collect$ "u t section4 7#c7 ,limitation ,! total am\nt ( civil money p5alties impos$ "u p>agraph 7#a7 or 7#b7 ) respect to a ye> & an individual or entity describ$ 9 subp>agraph 7,a7 or a manufactur] or di/ributor describ$ 9 subp>agraph 7,b71 respectively1 %all n exce$ #aej1jjj4 7d7 ,drug sample di/ribution in=mation 7#a7 ,9 g5]al ,n lat] ?an ,janu>y #a ( ea* ye> 7beg9n+ ) #bjba71 ! ,secret>y %all ma9ta9 a li/ conta9+ in=mation relat$ to ! di/ribution ( samples ( applicable drugs4 ,su* li/ %all provide ! foll[+ in=mation ) respect to ! prec$+ ye>3 7,a7 ,! "n ( ! manufactur] or au?oriz$ di/ributor ( record ( an applicable drug = :i* samples 7 reque/$ or di/ribut$ "u ?is section4 7,b7 ,! quantity & class ( drug samples reque/$4 7,c7 ,! quantity & class ( drug samples di/ribut$4 7#b7 ,public availability ,! ,secret>y %all make ! in=mation 9 su* li/ available to ! public on ! ,int]net ,web site ( ! ,food & ,drug ,adm9i/ration4 4 7b7 ,,fda ma9t5ance ( in=mation ,! ,food & ,drug ,adm9i/ration %all ma9ta9 in=mation available to affect$ report+ companies to ensure _! ability to fully comply ) ! requirem5ts ( section #aabh;,h ( ! ,social ,security ,act4 7c7 ,prohibition on di/ribution ( samples ( opioids ,section #ejc7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;d77 is am5d$-- 7#a7 by mov+ ! m>g9 ( p>agraph 7#d7 #b ems to ! left2 & 7#b7 by add+ at ! end ! foll[+3 7#e7 ,no p]son may di/ribute a drug sample ( a drug t is-- 7,a7 an applicable drug 7z def9$ 9 section #aabh;,h7d7 ( ! ,social ,security ,act72 7,b7 a controll$ sub/ance 7z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act7 = :i* ! f9d+s requir$ "u section #bjb7;b77#b7 ( su* ,act h be5 made2 & 7,c7 approv$ "u section #eje = use 9 ! managem5t or treatm5t ( pa9 7o!r ?an = ! managem5t or treatm5t ( a sub/ance use disord]74 4 7d7 ,med,p,a,c report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,m$ic>e ,paym5t ,advisory ,commission %all conduct a /udy on ! impact ( drug samples on provid] prescrib+ practices & heal? c>e co/s & may1 z ! ,commission deems appropriate1 make recomm5dations on su* /udy4 #g4 ,requir+ prescription drug plan sponsors to include real-"t b5efit in=mation z "p ( su* sponsor's electronic prescription program "u ! ,m$ic>e program ,section #ahfj;,d-#d7;e77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77#b77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ ,to ! ext5t & ins]t+ ,except z provid$ 9 subp>agraph 7,f71 to ! ext5t2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,real-"t b5efit in=mation 7i7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjba1 ! program %all implem5t real-"t b5efit tools t are capable ( integrat+ ) a prescrib+ heal? c>e pr(essional's electronic prescrib+ or electronic heal? record sy/em = ! transmission ( =mul>y & b5efit in=mation 9 real "t to prescrib+ heal? c>e pr(essionals4 ,) respect to a cov]$ "p ,d drug1 su* tools %all be capable ( transmitt+ su* in=mation specific to an individual enroll$ 9 a prescription drug plan4 ,su* in=mation %all include ! foll[+3 7,i7 ,a li/ ( any cl9ically-appropriate alt]natives to su* drug includ$ 9 ! =mul>y ( su* plan4 7,,ii7 ,co/-%>+ in=mation = su* drug & su* alt]natives1 includ+ a description ( any v>iance 9 co/ %>+ bas$ on ! ph>macy disp5s+ su* drug or su* alt]natives4 7,,iii7 ,in=mation relat+ to :e!r su* drug is includ$ 9 ! =mul>y ( su* plan & any prior au?orization or o!r utilization managem5t requirem5ts applicable to su* drug & su* alt]natives s includ$4 7ii7 ,electronic transmission ,! provisions ( subclauses 7,i7 & 7,,ii7 ( clause 7ii7 ( subp>agraph 7,e7 %all apply to an electronic transmission describ$ 9 clause 7i7 9 ! same mann] z su* provisions apply ) respect to an electronic transmission describ$ 9 clause 7i7 ( su* subp>agraph4 7iii7 ,special rule = #bjba ,! program %all be deem$ to be 9 compliance ) clause 7i7 = #bjba if ! program complies ) ! provisions ( section #dbc4afj7;b77#g7 ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation71 = su* ye>4 7iv7 ,rule ( con/ruction ,no?+ 9 ?is subp>agraph %all be con/ru$ z to all[ a real "t b5efits tool to /e] an individual1 )\t ! cons5t ( ! individual1 to a p>ticul> ph>macy or ph>macy sett+ ov] _! pref]r$ ph>macy sett+ nor prohibit ! designation ( a pref]r$ ph>macy "u su* tool4 4 #h4 ,s5se ( ,congress reg>d+ ! ne$ to exp& comm]cially available drug pric+ comp>ison plat=ms ,x is ! s5se ( ,congress t-- 7#a7 comm]cially available drug pric+ comp>ison plat=ms c1 at no co/1 help pati5ts f9d ! l[e/ price = _! m$ications at _! local ph>macy2 7#b7 su* plat=ms %\ld be integrat$1 to ! maximum ext5t possible1 9 ! heal? c>e deliv]y ecosy/em2 & 7#c7 ph>macy b5efit manag]s %\ld "w to disclose g5]ic & br& "n drug prices to su* plat=ms to ensure t-- 7,a7 pati5ts c b5efit f ! l[e/ possible price available to !m2 & 7,b7 ov]all drug prices c be r$uc$ z m educat$ pur*as+ decisions are made bas$ on price transp>5cy4 #i4 ,te*nical corrections 7a7 ,9 g5]al ,section #cjbb7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#eb7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,application ( au?orities "u ,inspector ,g5]al ,act ( #aigh ,9 c>ry+ out ?is subsection1 ! ,inspector ,g5]al %all h ! same au?orities z provid$ "u section #f ( ! ,inspector ,g5]al ,act ( #aigh 7#e ,u4,s4,c4 ,app474 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all take effect z if includ$ 9 ! enactm5t ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee74 ,am5d ! title s z to read3 ,a bill to require report+ = c]ta9 drug price in=mation1 & = o!r purposes44 ,septemb] #bd1 #bjai ,report$ ) am5dm5ts1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be pr9t$